louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01364519: A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers
Official title: A Randomized, Double-Blind (3rd Party Open), Placebo-Controlled, 2-Way Crossover Study To Determine The Effects Of A Single Inhaled Dose Of 500 MCG Fluticasone Propionate On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment of inflammation will be via sputum induction.

Detailed description: Methodology Validation

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Normoresponsive airways - histamine PC20\>16mg/mL
* Able to complete sputum induction successfully

Exclusion Criteria:

* Non (or ex) smokers
* No LPS challenge in previous 4 weeks

Primary outcomes:
measure: Sputum Neutrophil (%)
timeFrame: 6 hours post LPS challenge
Secondary outcomes:
measure: Sputum Inflammatory cytokines (IL-6, MCP-1 and MIP1beta)
timeFrame: 6 hours post LPS challenge
measure: Blood Inflammatory Cytokines (IL-6, MCP-1, fibrinogen, CC16, CRP and MIP1beta)
timeFrame: 1, 4 and 6 hours post LPS challenge
measure: Sputum cells (macrophages and total cell count)
timeFrame: 6 hours post LPS challenge
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
state: Greater Manchester
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06617819: Influence of Different Prostheses on Postoperative Clinical Function in Total Knee Arthroplasty
Official title: Influence of Different Prostheses(CR Vs. PS) on Postoperative Clinical Functional Scores in Total Knee Arthroplasty Based on Extramedullary Femoral Osteotomy Techniques and Functionalist Alignment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Arthropathy
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS))


Eligibility criteria: Inclusion Criteria:

1. Age 45-80 years, any gender, BMI \< 35 kg/m2
2. Initial diagnosis of bilateral knee OA (Kellgren-Lawrence classification grades 3 or 4). Patients who are to undergo simultaneous primary bilateral knee arthroplasty
3. Inversion deformity ≤ 15°
4. Posterior cruciate ligament integrity

Exclusion Criteria:

1. History of knee surgery (ligament, osteotomy, etc.)
2. knee flexion\<90°.
3. flexion contracture of one knee \> 10°
4. Comorbidity with other diseases, such as peripheral neuropathy, malignant tumors, rheumatism, etc.
5. Posterior cruciate ligament injury
6. Those assessed to be intolerant of surgery

Primary outcomes:
measure: Knee Society Score, KSS
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Secondary outcomes:
measure: WOMAC
timeFrame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
measure: Stride length
timeFrame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
measure: Stride frequency
timeFrame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
measure: Percentage of stance phase
timeFrame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
state: Jiangsu
Study officials:
affiliation: Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
name: Zhihong Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01156519: Contribution of Salivary Cortisol in the Detection of Infra-clinic Cortisol Adenoma (ACIC)
Official title: Detection of Infra-clinic Cortisol Adenoma (ACIC) in a Population of Android Obese With High Metabolic Risk: Contribution of Salivary Cortisol at 23 Hours
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Infra-clinic cortisol adenoma
Salivary cortisol
Obesity
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-07-05
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test (Suppression of serum cortisol \<1.8 μg/dL ) as the reference method for the detection of ACIC in obese subjects


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years)
* Signed informed consent
* Subjects affiliated with an appropriate social security system
* Body mass index above 30 kg/m2 and
* Pathological waist circumference according to criteria of NCEP ATPIII (men : 94 cm and women : 80 cm)

Exclusion Criteria:

* Pregnancy
* Sepsis
* Recent surgery (less than 30 days)
* Any recent severe acute conditions requiring hospitalisation (less than 30 days)
* Recent use (\< 7 days) of oral steroids, inhaled, dermal, collyrium, infiltration
* Long-term oral corticosteroids
* Nicotinic substitute or per os licorice in 2 weeks before the inclusion

Primary outcomes:
measure: Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage
Secondary outcomes:
measure: Number of patients with negative salivary cortisol dosage among patients with negative serum cortisol dosage
measure: Comparing the results of salivary cortisol dosage and serum cortisol dosage
measure: Comparing the results of the two salivary samples
measure: Number of patients with metabolic complications of obesity among patients with ACIC
measure: Number of patients with severe type 2 diabetes among patients with ACIC
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Bertrand CARIOU, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03915119: Fuzzy AI Using VR for Collision Prevention
Official title: Genetic Fuzzy Artificial Intelligence Driven Virtual Reality for Prevention of Collision-based Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 45
Sex: ALL
Minimum age (years): 14
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to develop and test a VR training system that integrates GFT AI with virtual obstacle scenarios that, when compared to a sham-VR training system, is hypothesized to increase neuromechanical and perceptual-motor fitness, decrease collision frequency and impact forces for soccer athletes, during a single training session and also when assessed at approximately 1 week and 1 month following training.

Detailed description: Player collisions cause over 70% of concussion injuries in contact sports, in addition to 50% of lower extremity injuries and 40% of catastrophic knee ligament injuries. The majority of these collisions are unanticipated, and associated with reduced neuromechanical and perceptual-motor fitness underlying an athlete's adaptability to on-field conditions. Thus, training collision anticipation necessitates a method that taps into neuromechanical and perceptual-motor fitness. Virtual reality (VR) is a tool that can target these mechanisms, while providing a safe, well-controlled environment for assessment and training. The current proposal innovates on VR with the integration of genetic fuzzy tree (GFT) artificial intelligence (AI) to drive scenario configuration designed to target modifiable mechanisms and tailored to the individual athlete's performance capabilities, for the optimization of behavior modification and skill transfer. The current study will examine test a GFT AI-driven VR collision anticipation training compared to a sham-VR training system in healthy soccer athletes.

Eligibility criteria: Inclusion Criteria:

* healthy
* varsity high school or collegiate soccer athlete

Exclusion Criteria:

* unable to participate in soccer
* history of congenital or acquired cognitive, ophthalmologic, or neurological disorders including developmental delay, brain tumor, stroke, or known peripheral or central vestibular disorders
* patients who have begun anti-depressant, stimulant or anti-seizure medications for treatment of their symptoms or for other, unrelated reasons within two months of testing will be excluded from testing

Primary outcomes:
measure: Pro-saccades test
timeFrame: 10 minutes
Secondary outcomes:
measure: Self paced saccades
timeFrame: 10 minutes
measure: Anti-saccades test
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinanti Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinanti Childrens Hospital
name: Adam Kiefer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02901119: Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation
Official title: Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Disease
Nutrition Disorders
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Malnutrition is prevalent among chronic liver disease patients. Inadequate ingestion and/or metabolic alterations modify the body composition and biological functions. The purpose of this study is to determine whether whey protein comsumption, due to amino acid profile, digestibility and bioactive compounds may be beneficial for patients waiting for liver transplantation

Detailed description: A randomized, double-blind, intervention study in which patients are randomly assigned to receive packages of 20g of whey protein (WP) or casein (CA) to take twice a day (20g in the morning and 20g at night), as a supplement, during 15 days. They are monitored weekly by calls. Regular usual diet is maintained. Patients underwent muscle functionality assessment by handgrip dynamometry and 6-min. walking test and, the inflammatory response by plasmatic cytokines. All tests are performed at the beginning and the end of intervention.

Eligibility criteria: Inclusion Criteria:

* Chronic liver disease, liver transplantation

Exclusion Criteria:

* Children, illiterate, elderly, renal failure

Primary outcomes:
measure: Nutritional status
timeFrame: Two years
measure: Nutritional status
timeFrame: Two years
Secondary outcomes:
measure: Heart rate variability
timeFrame: Two years
measure: Resting energy expenditure
timeFrame: Two years
Other outcomes:
Locations:
city: Belo horizonte
country: Brazil
facility: UFMG Hospital
state: Minas Gerais
Study officials:
References:
Clinical trial NCT04520919: Feasibility Study of a Hemodynamic Parameter Algorithm
Official title: Feasibility Study of a Hemodynamic Parameter Algorithm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who need surgery

Brief summary: An algorithm to calculate hemodynamic parameters based on blood pressure waveform was developed by collecting arterial blood pressure of patients during surgery


Eligibility criteria: Inclusion Criteria:

* surgery patients

Exclusion Criteria:

* Weight ≤18kg arrhythmology cardiac disfunction

Primary outcomes:
measure: arterial blood pressure
timeFrame: 30min~1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department
state: Zhejiang
Study officials:
References:
Clinical trial NCT02712619: Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers
Official title: An Open-label, Parallel Group Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of 250/1000 mg of Metformin IR After Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two doses of metformin with 12 hour interval

* low dose group (375/250 mg)
* high dose group (1000/1000mg)

Detailed description: A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between different metformin dose groups.

Eligibility criteria: Inclusion Criteria:

* Age 20 to 45
* Body weight 50 to 100 kg
* fasting serum glucose 70 to 125 mg/dL
* who provide informed consent voluntarily

Exclusion Criteria:

* any significant renal, gastrointestinal, hepatic, and metabolic condition
* any co/prior medication within 14 days of study drug administration

Primary outcomes:
measure: Maximum plasma concentration
timeFrame: 0-12 hour
measure: Area under the metformin concentration curve
timeFrame: 0-12 hour
measure: Area under the glucose curve
timeFrame: 2-5 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chung H, Oh J, Yoon SH, Yu KS, Cho JY, Chung JY. A non-linear pharmacokinetic-pharmacodynamic relationship of metformin in healthy volunteers: An open-label, parallel group, randomized clinical study. PLoS One. 2018 Jan 17;13(1):e0191258. doi: 10.1371/journal.pone.0191258. eCollection 2018.
Clinical trial NCT04015219: Management of Signs and Symptoms Associated With Dry Eye Disease
Official title: A Prospective, Randomized, and Controlled Clinical Study to Evaluate PROKERA® in the Management of Signs and Symptoms Associated With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: BioTissue Holdings, Inc
Sponsor class: INDUSTRY
First posted: 2019-07-10
Enrollment: 3
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: A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited.


Eligibility criteria: Inclusion Criteria:

* Subjects with moderate dry eye defined as corneal fluorescein staining score of ≥ 3
* Age ≥ 18 years
* Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
* Willing to sign a written informed consent to participate
* Able to follow study instructions, with the intention of completing all required visits

Exclusion Criteria:

* Presence of persistent corneal epithelial defect or ulcer in either eye
* Presence of active ocular infection in either eye
* Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis
* Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis
* Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD)
* Contact lens wear
* History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
* Presence of cicatricial ocular surface diseases
* A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
* Any scheduled or planned ocular or systemic surgery or procedure during the study
* Pregnancy and women who are expecting to be pregnant.
* Current enrolment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study

Primary outcomes:
measure: Corneal Fluorescein Staining
timeFrame: 1 month
Secondary outcomes:
measure: Eye Dryness Score
timeFrame: 1 month
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 1 month
Other outcomes:
Locations:
city: Miami
country: United States
facility: Center of Excellence in Eye Care
state: Florida
Study officials:
References:
Clinical trial NCT01257919: Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Official title: Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Papulopustular Rosacea
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2010-12-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel.

Assessment of safety after repeated skin application.


Eligibility criteria: Inclusion Criteria:

* diagnosis of moderate papulopustular rosacea
* free of any clinically significant disease

Exclusion Criteria:

* body weight less than 50 or more than 130 kg
* clinically significant disease which could interfere with the study

Primary outcomes:
measure: Baseline corrected area under the curve (AUC)
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Novum Pharmaceutical Research Services of Nevada Inc.
state: Nevada
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03855319: Neurofeedback Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment
Official title: SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Neurofeedback
Electroencephalography
MCI
Alzheimer
Lead sponsor: Broca Hospital
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: no randomized, no controlled
Primary purpose: PREVENTION

Brief summary: This is a non-pharmacological pilot study showing the improvement of a SMR/theta neurofeedback training program on cognitive performance and EEG activity in Elderly with Mild Cognitive Impairment.

Detailed description: Neurofeedback training (NF) as self-regulation method of brain activity, may be beneficial in elderly with mild cognitive impairment. In this pilot study, the investigators studied whether a sensorimotor(SMR)/theta NF training could improve cognitive performance and brain electrical activity in a sample group of elderly patients with mild cognitive impairment. Twenty participants performed an electroencephalography recording, a battery of neuropsychological tests before the neurofeedback training program (T0), following the neurofeedback training program (T1) and 1-month follow-up (T2).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Mild Cognitive Impairment
* education level of 9 years of studies minimum
* righthandedness
* subjective memory complaint confirmed by an informant
* a Mini Mental Status Examination score \>20.
* preserve activity of daily living and absence of dementia.

Exclusion Criteria:

* elderly persons who were under guardianship
* resident in nursing facilities
* neurological disease, psychiatric disease
* and involved in another cogniitve intervention.

Primary outcomes:
measure: Rey Auditory Verbal Learning test
timeFrame: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up
Secondary outcomes:
measure: Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.
timeFrame: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Study Principal Investigator
name: anne-Sophie AR Rigaud, Professor
role: PRINCIPAL_INVESTIGATOR
References: