louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02379169: Effects of Sea Buckthorn Oil and Lutein on Eye Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Risk Factors for Age Related Macular Degeneration
Keywords: macular pigment optical density, age related macular degeneration, dry eye, vision
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Aromtech Ltd.
First posted: 2015-03-04
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Low macular pigment optical density has been associated with increased risk of age-related macular degeneration, an important cause of vision problems in the elderly population. Dry eye is multifactorial disease of tears and the ocular surface associated with symptoms of dryness, grittiness, burning and redness of eyes. The risk of dry eye increases with age. The aim is to investigate the effects of sea buckthorn oil complemented with lutein on eye health, specifically on the macula.


Eligibility criteria: Inclusion Criteria:

- macular pigment optical density equal to or less than 0,40 OD

Exclusion Criteria:

* diabetic retinopathy
* macular changes associated with high blood pressure
* signs of macular degeneration: classes 2, 3 and 4 according to the Rotterdam study (Mol Vis 2012: 657-74)
* severe eye diseases, exluding cataract. The intervention will begina after surgery and recovery from cataract

Primary outcomes:
measure: Change in macular pigment optical density from baseline to 6 mo
timeFrame: 0 mo, 3 mo, 6 mo
Secondary outcomes:
measure: Change in symptoms of dry eye from baseline to 6 mo
timeFrame: 0 months, 3 months, 6 months
measure: Change in serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol) from baseline to 6 mo
timeFrame: 0 months, 6 months
measure: Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo
timeFrame: 0 months, 6 months
measure: Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo
timeFrame: 0 months, 6 months
measure: Change in contrast sensitivity from baseline to 6 mo
timeFrame: 0 mo, 3 mo, 6 mo
measure: Change in vision aquity from baseline to 6 mo
timeFrame: 0 mo, 3 mo, 6 mo
measure: Change in vision functioning from baseline to 6 mo
timeFrame: 0 mo, 3 mo, 6 mo
measure: Change in tear film osmolarity from baseline to 6 mo
timeFrame: 0 mo, 3 mo, 6 mo
Other outcomes:
measure: Change in serum markers of sea buckthorn oil and lutein intake
timeFrame: 0 months, 6 months
Locations:
Study officials:
References:
Clinical trial NCT05922969: Safety of Low PEEP Maneuvers During ARDS Management
Official title: Safety of Low PEEP Maneuvers During ARDS Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome
Positive End Expiratory Pressure
Keywords: Acute Respiratory distress syndrome
Positive end expiratory pressure
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier VALENCIENNES
First posted: 2023-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PEEP in patients with moderate or severe ARDS

Brief summary: Acute Respiratory distress syndrome (ARDS) is a severe condition in which protective ventilation is a critical point in its management. Positive end expiratory pressure (PEEP) setting can be challenging for clinicians and high PEEP has been associated with better outcome in moderate and severe ARDS. Recently, recruitment to inflation ratio and airway closure have been investigated in order to help PEEP adjustment. However, ventilatory maneuvers are performed with a low level of PEEP and therefore expose to derecruitment and oxygen desaturation. So far, the risk of oxygen desaturation has not been investigated and risk factors are unknown.

The aim of this study is to evaluate the prevalence of oxygen desaturation during ventilatory maneuvers at low level of PEEP in patients with moderate or severe ARDS


Eligibility criteria: Inclusion Criteria:

* age : \> 18 yo
* inclusion criteria: ARDS, Mechanical ventilation, low PEEP maneuvers

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: prevalence of oxygen desaturation
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT02962869: Human Photoallergy Test (824/2016)
Official title: Human Photoallergy Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 53
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: To evaluate the potential of a test material to produce a photoallergic response


Eligibility criteria: Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive
* be lightly pigmented (Fitzpatrick Skin Type I, II, III)
* have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form (Health Insurance Portability and Accountability Act) in conformance with 45CFR Parts 160 and 164
* be in general good health as determined by the subject's medical history and in the discretion of the investigator

Exclusion Criteria:

* have a visible sunburn
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses
* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products
* subjects who are employees of the CRO (Contract Research Organization) and/or Bayer or is a household member of an employee

Primary outcomes:
measure: Intensity of skin reactions is evaluated by 5 point scale
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00490269: Ph1 Marinol Interaction Study - Part 2 - 1
Official title: Phase 1, Pilot Study to Examine the Cardiovascular Effects of Smoked Marijuana, Interactions With Oral Dronabinol, and Effects of Dronabinol on Withdrawal in Marijuana Dependent Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Marijuana Dependence
Keywords: Marijuana dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2007-06-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies.


Eligibility criteria: Inclusion Criteria:

* Must be between 18 and 45 years of age
* Must be in good general health and who meet DSM-IV diagnostic criteria for marijuana dependence
* Must be seeking treatment at time of study entry
* Must be able to understand and provide written informed consent
* Must provide 1 marijuana positive urine specimen (\> 50 ng/mL) within the 28-day screening period
* If female and of child bearing potential, agrees to use birth control.

Exclusion

Criteria:

* Please contact site for more information

Primary outcomes:
measure: Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.
timeFrame: Day 9 and 10
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of Health Science
state: Maryland
Study officials:
affiliation: Uniformed Services University of Health Science
name: Louis Cantilena, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03594669: Training for Injury Prevention in Collegiate Soccer Players
Official title: Sensorimotor Training for Injury Prevention in Collegiate Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletic Injuries
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Mississippi College
First posted: 2018-07-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will be conducted as pilot of a one-arm intervention using,1) pre- and post-participation measures of sensorimotor control and 2) injury incidence rate over the sports-season directly after completion of the intervention compared to injury incidence rate of a historical control (the 2017 soccer season at Mississippi College). Participants will include men and women athletes on soccer teams from one Division II institution.
Primary purpose: PREVENTION

Brief summary: The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players.

Detailed description: The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players. The hypothesis is that measures of sensorimotor control will improve and injury incidence rate will decrease after participation in an intervention aimed at restoration/refinement of sensorimotor control. This study will be conducted as a 1-arm intervention with pre- and post-participation measurement of sensorimotor control and completion of an exercise intervention. Statistical analyses will be completed to determine within group change pre-to post-intervention and injury risk by comparing injury rate in 2018 to injury rate of a historical control.

Eligibility criteria: Inclusion Criteria:

* Male and female athletes on the soccer roster who are eligible to play in the fall 2018 season at Mississippi College

Exclusion Criteria:

* Any athlete who has a current diagnosis of concussion (i.e. a non-medically cleared concussion), lower-extremity musculoskeletal injury, or other medical diagnosis that will prevent the athlete from participation in the intervention.

Primary outcomes:
measure: Change in clinical measures of sensorimotor control
timeFrame: Pre to post-treatment (1 month)
Secondary outcomes:
measure: Injury incidence rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Jennifer C Reneker, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05192369: A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers
Official title: A Four-Arm, Randomized, Crossover, Placebo and Active Controlled Study for the Evaluation of the Effect of Therapeutic and Supratherapeutic Doses of CTP-543 on the QT/QTc Intervals in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: CTP-543
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a four-arm, randomized, crossover, placebo and active controlled study to evaluate of the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking, adult males or females aged 18-60
* Body mass index of 18 to 32 mg/m2 at Screening
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or Electrocardiograms (ECGs)
* If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication
* Understands the study procedures in the informed consent form and be willing and able to comply with the protocol

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
* History of prolonged QT syndrome or a Corrected QT-interval (QTc) with Fridericia's correction (QTcF) \> 450 msec for males or QTcF \> 470 msec for females obtained at Screening visit or prior to the first dosing
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
* Positive results at Screening for human immunodeficiency virus, hepatitis B surface antigen or hepatitis C virus
* A positive test or history of incompletely treated or untreated tuberculosis

Primary outcomes:
measure: TQT Analysis
timeFrame: Before dosing (pre-dose) through 24 hours post-dose on Day 1, Day 4, Day 7, and Day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
Study officials:
References:
Clinical trial NCT04725669: Seroprevalence of Pertussis Among Children and Adolescents in Croatia
Official title: Seroprevalence of Pertussis Antibodies Among Children and Adolescents in Croatia - Investigation of the Waning Vaccine-induced Immunity in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immunogenicity, Vaccine
Lead sponsor: University Hospital for Infectious Diseases, Croatia
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2021-01-27
Enrollment: 1500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pertussis is a vaccine preventable disease caused by Bordetella pertussis. Older children and adolescents with pertussis continue to be a significant source of infection for incompletely vaccinated infants who are in harm for developing severe disease. The primary objective of our study is to estimate the duration of protection elicited by the current vaccination schedule against pertussis in Croatia.


Eligibility criteria: Inclusion Criteria:

* children and adolescents from 6 to 18 years of age treated through Emergency room and/or Day hospital of Pediatric Infectious Diseases Department at UHID;
* appropriate vaccination with pertussis component containing vaccine by date and at the appropriate time, according to Croatian NIP proven by insight in the Vaccination Record Card
* written informed consent obtained from the subject's parent or caregiver, as well as from participants ≥ 16 years old.

Exclusion Criteria:

* children under 6 years
* children and adolescents with acute respiratory symptoms
* children and adolescents with pertussis-like illness within 12 months
* children and adolescents with unknown, uncompleted or irregular vaccination record
* inpatients
* children and adolescents with immunodeficiencies

Primary outcomes:
measure: Waning of vaccine-induced immunity
timeFrame: 1 day
Secondary outcomes:
measure: Seroprevalence
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital for Infectious Diseases "Dr Fran Mihaljević"
Study officials:
affiliation: University Hospital for Infectious Diseases "Dr Fran Mihaljević"
name: Goran Tešović
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03064269: CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
Official title: CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: B-cell Acute Lymphocytic Leukemia
Keywords: CNS B cell acute lymphocytic leukemia
Lead sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Soochow University
First posted: 2017-02-27
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

Detailed description: CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Eligibility criteria: Inclusion Criteria:

1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
2. ALT/ AST 《 3x normal
3. Creatinine 《 3x normal
4. Age:10-60.
5. Signed informed consent

Exclusion Criteria:

1. Active hepatitis B , hepatitis C or HIV infection
2. Uncontrolled active infection
3. Pregnancy or breast-feeding women
4. Survival less than four weeks

Primary outcomes:
measure: The complete remission (CR) rate
timeFrame: Participants will be followed for the duration of the treatment, an expected average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Sheng-Li Xue, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen LY, Kang LQ, Zhou HX, Gao HQ, Zhu XF, Xu N, Yu L, Wu DP, Xue SL, Sun AN. Successful application of anti-CD19 CAR-T therapy with IL-6 knocking down to patients with central nervous system B-cell acute lymphocytic leukemia. Transl Oncol. 2020 Nov;13(11):100838. doi: 10.1016/j.tranon.2020.100838. Epub 2020 Jul 31.
Clinical trial NCT02376569: An Observational Pilot Study to Characterize Relationships Between Self-reported Information, Game Performance, and Passive Physiology Measures Throughout a Daily Cycle
Official title: An Observational Pilot Study to Characterize Relationships Between Self-reported Information, Game Performance, and Passive Physiology Measures Throughout a Daily Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Energy and Cognition
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population \>=18 years old

Brief summary: This study intends to collect self-reported information with multiple surveys about lifestyle habits, food and drink, state of mind (happy, sad, etc.) and traits (decision making, general personality, etc.) The purpose of this study is to understand relationships between self-reported information, game performance, and passive physiology measures throughout a daily cycle.


Eligibility criteria: Inclusion Criteria:

Must be \>=18 years old Must agree to participate via electronic consent Must agree to share e-mail and physical address (final dataset de-identified) Must own a computer and/or smartphone Must be a member of the survey panel and agree to take multiple surveys over 4-6 weeks Must complete the full surveys and not fail attention filters Must be able to access cognition games website and play the games Must be willing to wear a lifestyle assessment sensing device for 1 week

Exclusion Criteria:

Known skin reaction or allergy to metal Known skin reaction or allergy to medical adhesive Participation in another research study, behavior or new drug testing

Primary outcomes:
measure: To test the hypothesis that there are relationships between self-reported information, game performance, and passive physiology measures throughout a daily cycle.
timeFrame: 4-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PepsiCo Global R&D
name: Douglas A Marsteller, PhD
role: PRINCIPAL_INVESTIGATOR
References: