louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01821820: Pistachios, Performance, Metabolomics
Official title: Influence of Pistachios on Performance and Exercise-induced Inflammation, Oxidative Stress, and Immune Dysfunction in Athletes: a Metabolomics-based Approach.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Oxidative Stress
Immune Dysfunction
Keywords: Inflammation
Oxidative stress
Immune dysfunction
Metabolites
Lead sponsor: Appalachian State University
Sponsor class: OTHER
Collaborators: name: American Pistachio Growers
First posted: 2013-04-01
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Ingestion of 3 ounces of pistachio nuts per day for two weeks before and the day of cycling intensely for 75 kilometers will support substrate utilization during exercise (as determined through metabolomics) and improve performance compared to water only, and attenuate inflammation, oxidative stress, and immune dysfunction during 24 hours of recovery.


Eligibility criteria: Inclusion Criteria:

* Male endurance cyclists
* Capable of exercising for 2.5 h at a high intensity in the lab
* Ages 18-55
* Agree to train normally and stay weight stable.
* Agree to avoid the use of large dose vitamin/mineral supplements
* Agree to avoid herbs and medications that influence inflammation

Exclusion Criteria:

* Regularly take supplements or medicines known to effect inflammation.
* At moderate or high risk for cardiovascular disease.
* Younger than 18 or older than 55 years of age.
* No history of competing in cycling races.

Primary outcomes:
measure: Shifts in metabolites (metabolomics)
timeFrame: 14-day period
Secondary outcomes:
measure: Inflammation
timeFrame: 14-day period
measure: Immune Function
timeFrame: 14-day period
measure: Oxidative Stress
timeFrame: 14-day period
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: ASU Human Performance Laboratory, North Carolina Research Campus
state: North Carolina
Study officials:
affiliation: Appalachian State University
name: David C. Nieman, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dreher ML. Pistachio nuts: composition and potential health benefits. Nutr Rev. 2012 Apr;70(4):234-40. doi: 10.1111/j.1753-4887.2011.00467.x.
citation: Nieman DC, Scherr J, Luo B, Meaney MP, Dreau D, Sha W, Dew DA, Henson DA, Pappan KL. Influence of pistachios on performance and exercise-induced inflammation, oxidative stress, immune dysfunction, and metabolite shifts in cyclists: a randomized, crossover trial. PLoS One. 2014 Nov 19;9(11):e113725. doi: 10.1371/journal.pone.0113725. eCollection 2014.
Clinical trial NCT02213120: To Study the Characteristics of Different Types of Vertigo in Patients Attending the Ear Nose & Throat (ENT) Clinics.
Official title: To Study the Characteristics of Different Types of Vertigo in Patients Attending the ENT Clinics.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertigo
Keywords: Vertigo, Dizziness
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Dimension Research
First posted: 2014-08-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic/Private Clinic

Brief summary: The VERTIGO study is likely to help determine characteristics of different types of vertigo in patients presenting in the Ear Nose \& Throat (ENT) clinics with complaints of dizziness. Moreover, it will also help to develop an understanding about the current management practices of this condition at local level.


Eligibility criteria: Inclusion Criteria:

* Male or female patients 18 years of age and older
* Patients with vestibular vertigo of known or unknown origin
* Patients who are willing and able to provide written informed consent

Exclusion Criteria:

* Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion based on clinical judgment
* Patient with psychiatric disorders, significant neurological disorder or spinal cord damage that would make the evaluation difficult for the investigator
* Patients who are not willing to give informed consent
* Patients with a known history of hypersensitivity to betahistine
* Patients with a history of pheochromocytoma

Primary outcomes:
measure: Characteristics (Different Types) of dizziness
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life (QoL) of patients at baselines
timeFrame: 6 months
measure: Management of vertigo currently in practice
timeFrame: 6 months
measure: QoL of patients post treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Hyderabad
country: Pakistan
facility: Research facility ID ORG-001139
city: Islamabad
country: Pakistan
facility: Research facility ID ORG-001053
city: Karachi
country: Pakistan
facility: Research facility ID ORG-001070
city: Karachi
country: Pakistan
facility: Research facility ID ORG-001051
city: Karachi
country: Pakistan
facility: Research facility ID ORG-001069
city: Karachi
country: Pakistan
facility: Research facility ID ORG-001050
city: Lahore
country: Pakistan
facility: Research facility ID ORG-001060
city: Lahore
country: Pakistan
facility: Research facility ID ORG-001054
city: Lahore
country: Pakistan
facility: Research facility ID ORG-001055
city: Lahore
country: Pakistan
facility: Research facility ID ORG-001061
city: Peshawar
country: Pakistan
facility: Research facility ID ORG-001052
Study officials:
affiliation: Abbott
name: Raeefuddin Ahmed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02540720: The Research of Standard Diagnosis and Treatment for Severe HSP in Children
Official title: The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Henoch-Schoenlein Purpura
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.

Detailed description: Henoch-Schonlein purpura (HSP) is a systemic vasculitis affecting small vessels with immunoglobulin A (IgA)-dominant immune deposits. The clinical manifestations of severe HSP vary from massive hemorrhage and necrosis of the skin to severe gastrointestinal symptoms. The course of the disease would encounter delay and relapse. To some extent, the traditional therapy alleviate the clinical symptoms, but fail to timely clear up the immune depositions, causing the damage to the kidney.

In the study, the patients will be given dexamethasone 0.5mg/kg/d, then be randomised to receive either gamma globulin i.v. or hemoperfusion if the disease can't be controlled with steroid treatment for more than two days.

The investigators will explore the biological markers and compare the efficacy and safety of both measures in the treatment of serve HSP in children. The purpose of the study is to optimize the treatment of severe HSP for children with different ages.

Eligibility criteria: Inclusion Criteria:

* Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days

Exclusion Criteria:

* The children with congenital diseases

Primary outcomes:
measure: The Symptoms of Digestive Tract
timeFrame: 2 weeks
measure: The Symptoms of Joint System
timeFrame: 2 weeks
Secondary outcomes:
measure: The Skin Rash
timeFrame: 2 weeks
measure: Renal function
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Children's Hospital
state: Jiangsu
Study officials:
affiliation: Department of Nephrology, Nanjing children's hospital
name: Aihua Zhang, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06647420: The Effect of Music Listening on Nursing Students
Official title: The Effect of Sedative and Stimulative Music Listening on State-Anxiety, Heart Rate, and Galvanic Skin Response in Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Physiological Stress
Keywords: Heart rate
Skin conductance
Music
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the effect of sedative and stimulative music listening on physiological responses among nursing students.


Eligibility criteria: Inclusion criteria:

* a senior, junior, or second-semester sophomore in the traditional undergraduate Bachelor of Science in Nursing (BSN) program
* a student in the accelerated BSN program

Exclusion criteria:

•self-reported hearing impairments.

Primary outcomes:
measure: Change in Heart Rate
timeFrame: baseline, up to 12 minutes
measure: Change in Skin Conductance
timeFrame: baseline, up to 12 minutes
measure: Change in Anxiety Level
timeFrame: baseline, up to 12 minutes
Secondary outcomes:
measure: The Degree of Stress Experienced by A Nursing Student measured by the Perceived Stress Scale for Nursing Students (PSS) Likert Scale
timeFrame: up to 5 minutes
measure: Liking Song Scale (4-point Likert Scale)
timeFrame: up to 5 minutes
measure: Familiarity Song Scale (Rating scale)
timeFrame: up to 5 minutes
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami School of Nursing and Health Studies
state: Florida
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Coral Gables
country: United States
facility: Weeks Music Library and Technology Center
state: Florida
Study officials:
affiliation: University of Miami
name: Teresa Lesiuk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02233920: Post-marketing Surveillance of Ventilat® Metered Dose Inhaler in Chronic Obstructive Bronchitis
Official title: Postmarketing Surveillance Study (as Per § 67(6) AMG [German Drug Law]) of Ventilat® Metered-dose Inhaler in Chronic Obstructive Bronchitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-09
Enrollment: 716
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with chronic obstructive bronchitis disease recruited at pneumologists

Brief summary: Study to obtain further information on the tolerability and efficacy of Ventilat® metered-dose inhaler in the treatment of Chronic Obstructive bronchitis under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Primarily Patients of both genders older than 40 years, who suffer from Chronic Obstructive bronchitis
* Only patients who have not been treated with an anticholinergic within the last year are to be considered for inclusion

Exclusion Criteria:

•Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Ventilat® metered dose inhaler

Primary outcomes:
measure: Change in the clinical picture
timeFrame: after 4 weeks
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 4-point scale
timeFrame: after 4 weeks
measure: Assessment of efficacy by patient on a 4-point scale
timeFrame: after 4 weeks
measure: Number of patients with adverse drug reactions
timeFrame: up to 4 weeks
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: after 4 weeks
measure: Assessment of patient by investigator on a 4-point scale
timeFrame: after 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06110520: Violet Light for the Suppression of Myopia
Official title: Violet Light for Treatment of Myopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Phototherapy
Keywords: Myopia
Violet Light
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 72
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three single groups:

1. Violet + / Lens + Lamp emits violet light and subjects are either wearing no refractive correction or wearing CR-39 lenses that completely transmit violet light.
2. Violet + / Lens - Lamp emits violet light and subjects are wearing violet-filtering glasses that block out violet light from reaching their eyes.
3. Violet - / Lens - Lamp does not violet light and subjects are wearing CR-39 lenses that completely transmit violet light.
Primary purpose: TREATMENT

Brief summary: The study explores the suppression of myopia via violet light.

Detailed description: The study uses violet light-emitting lamps as the variable and regular, white light lamps as the control in assessing whether violet light, especially during over periods of dawn and dusk could help suppress the progression of myopia in developing children.

Eligibility criteria: Inclusion Criteria:

* Children must be between 5 to \<13 years old.
* Diagnosis of Myopia (ICD-10-CM Diagnosis

Code H52.13) with refractive error:

1. Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
2. Astigmatism \<=1.50D in both eyes
3. Anisometropia \<=1.00D SE • Relocation outside of the CCHMC area within the next 12 months is not anticipated.

Exclusion Criteria:

Current or previous myopia treatment with atropine, pirenzepine, or other antimuscarinic agents

* Current or previous use of bifocals, progressive addition lenses, or multi-focal contact lenses
* Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression
* Current or prior history of manifest strabismus, amblyopia, or nystagmus
* Abnormality of cornea, lens, central retina, iris, or ciliary body
* Prior eyelid, strabismus, intraocular, or refractive surgery
* Down syndrome or cerebral palsy

Primary outcomes:
measure: Axial Length
timeFrame: Measured at baseline, and 12 months.
measure: Refractive Error
timeFrame: Measured at baseline, and 12 months.
measure: Visual Acuity
timeFrame: Measured at baseline, and 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT04385082: Cannabis Effects as a Function of Sex
Official title: Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pain
Abuse, Drug
Keywords: Pain
Cannabis
THC
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-05-12
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women

Detailed description: The proposed study will compare smoked cannabis's dose-dependent, analgesic and abuse-related effects between men and women and variables that underlie these sex-dependent differences, including pharmacokinetics of THC.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female aged 21-55 years
* Report use of cannabis an average of 1-7 days per week
* Not currently seeking treatment for their cannabis use
* Urine test positive for recent cannabis use for heavy users
* No reported adverse effects with cannabis smoking in light users
* Have a Body Mass Index from 18.5 - 34kg/m2.
* Able to perform all study procedures
* FEMALES: Currently practicing a non-hormonal effective form of birth control
* FEMALES: Must be regularly cycling

Exclusion Criteria:

* Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or cannabis use disorder
* Report using other illicit drugs in the prior 4 weeks
* History or current evidence of severe psychiatric illness or medical condition judged by the study physician and PI to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
* Current use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
* Current pain
* Insensitivity to the cold water stimulus of the Cold Pressor Test
* FEMALES: using a hormonal contraceptive

Primary outcomes:
measure: Subject-rated drug effects
timeFrame: 5 hours
measure: Analgesia as measured using the Cold Pressor Test
timeFrame: 5 hours
measure: Pharmacokinetics of THC and metabolites
timeFrame: 5 hours
Secondary outcomes:
measure: Drug reinforcement using the cannabis self-administration task
timeFrame: 5 hours
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: Ziva Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04391582: Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds
Official title: Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds: a Randomized Controlled Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Burns
Keywords: Burns
Wounds and Injuries
Biocompatible Materials
Nile Tilapia
Oreochromis niloticus
Lead sponsor: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was an open-label, monocentric, randomized phase II clinical trial.
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of Nile tilapia skin as a xenograft for the treatment of partial-thickness burn wounds in children.

Detailed description: This is an open-label, monocentric, randomized phase II pilot study conducted in Fortaleza, Brazil. The study population consisted of 30 children between the ages of 2 and 12 years with superficial "partial-thickness" burns admitted less than 72 hours from the thermal injury. In the test group, the tilapia skin was applied. In the control group, a thin layer of silver sulfadiazine cream 1% was applied.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 2 and 12 years admitted to our institution with superficial partial thickness burns less than 72 hours from the thermal injury

Exclusion Criteria:

* Patients were excluded for a burn greater than 15% total body surface area (TBSA);
* Presence of a previous treatment for the current burn;
* Presence of a chemical or electrical burn;
* Presence of other significant diseases that could impact the volunteer's participation in the study;
* Presence of hypersensitivity to materials used in the study or to related compounds.

Primary outcomes:
measure: Complete burn wound healing
timeFrame: Day 11
measure: Assessment of pain via the Faces Pain Scale-Revised (FPS-R).
timeFrame: Day 11
measure: Assessment of pain via CONFORT-B scale.
timeFrame: Day 11
measure: Assessment of pain via FLACCr scale.
timeFrame: Day 11
Secondary outcomes:
measure: Number of dressings performed.
timeFrame: Day 11
measure: Total amount of anesthetics and analgesics required throughout the treatment
timeFrame: Day 11
measure: Evaluation of burn improvement via the Clinical Global Impression Scale-Improvement (CGI-I).
timeFrame: Day 3, day 5, day 7, day 9 and day 11
measure: Evaluation of burn severity via the Clinical Global Impression Scale- Severity (CGI-S).
timeFrame: Day 1, day 3, day 5, day 7, day 9 and day 11
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Burn Treatment Center, Dr. José Frota Institute
state: Ceará
Study officials:
References:
Clinical trial NCT01912482: Cardiorespiratory Training and Ventilatory Muscle Strength
Official title: Chronic Effect of Cardiorespiratory Training on Ventilatory Muscle Strength in Elderly Women: Controlled Trial, Randomized and Double Blind.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Universidade Gama Filho
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The cardiorespiratory training can increase muscle strength ventilatory.

Detailed description: Specifically for being an experiment parallel factorial intervention after met the eligibility criteria for the participants will be randomly allocated to three groups: control, respiratory training, cardiorespiratory training (indoor Bike).

Eligibility criteria: Inclusion Criteria:

- Have lower maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values normative reference proposed by the Brazilian Society of Thoracic.

Exclusion Criteria:

* Not be voluntary to the present study.
* Conditions that oblige participants are absent for more than two weeks of activities performed in the experiment.

Primary outcomes:
measure: Ventilatory muscle strength
timeFrame: The ventilatory muscle strength (MIP and MEP) will be measured after 18 cardiorespiratory training sessions held in 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Gama Filho University
state: RJ
Study officials:
affiliation: Gama Filho University
name: Fabio D Pereira, MSc
role: PRINCIPAL_INVESTIGATOR
References: