louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04252599: Upper Airway Function and Cardiorespiratory Performance in Impair Trunk Motor Control Multiple Sclerosis Patients.
Official title: Upper Airway Function and Cardiorespiratory Performance in Impair Trunk Motor Control Multiple Sclerosis Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Have a diagnosis of MS in any of its forms according to McDonald criteria
* Were aged higher than 18 years
* No pathology in the uppers extremities
* Capacity to understand and response the questionnaires
* Ability to provide informed consent.

Exclusion Criteria:

* Cancer diagnoses, cognitive or psychiatric disorders, severe musculoskeletal disorders, severe orthopaedic problems, organ failure, incapacity to cooperate
* Inability to provide informed consent.

Brief summary: Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact and economic consequences. It is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. Different areas are affected, including upper airway function, trunk motor control and cardiorespiratory performance. The aim of this study was to determinate the relevance of trunk motor control in upper airway function and cardiorespiratory performance in patients with multiple sclerosis.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of MS in any of its forms according to McDonald criteria
* Were aged higher than 18 years
* No pathology in the uppers extremities
* Capacity to understand and response the questionnaires
* Ability to provide informed consent.

Exclusion Criteria:

* Cancer diagnoses, cognitive or psychiatric disorders, severe musculoskeletal disorders, severe orthopaedic problems, organ failure, incapacity to cooperate
* Inability to provide informed consent.

Primary outcomes:
measure: Trunk motor control
timeFrame: baseline
measure: Swallowing function
timeFrame: baseline
measure: Swallowing function
timeFrame: baseline
measure: Ventilation function
timeFrame: baseline
measure: Phonation function
timeFrame: baseline
measure: The exercise capacity focussed on lower limbs
timeFrame: baseline
measure: The exercise capacity focussed on upper limbs
timeFrame: baseline
measure: The anaerobic threshold
timeFrame: baseline
Secondary outcomes:
measure: Psychological status
timeFrame: baseline
measure: Psychological status
timeFrame: baseline
measure: The degree of neurological functioning
timeFrame: baseline
measure: The impact of the multiple sclerosis disease
timeFrame: baseline
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Healthy Sciences
Study officials:
References:
Clinical trial NCT03430999: SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects
Official title: SUNCIST: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of Intravenous Administration of Calmangafodipir in Healthy Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)
Lead sponsor: Egetis Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-02-13
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian) subjects.


Eligibility criteria: Inclusion Criteria:

* BMI within 18.0 to 30.0 kg/m2 and body weight not less than 50 kg
* Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic
* Non-smoker or not smoking for at least 12 months
* Be first generation Japanese (For Group 1 only), defined as:

  1. Born in Japan
  2. Has 2 Japanese biological parents and 4 Japanese biological grandparents
  3. Has lived outside of Japan for less than 5 years
  4. Has made no significant changes in lifestyle, including diet, since leaving Japan

Exclusion Criteria:

* Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, physical exam, vital signs, or electrocardiogram at screening
* Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
* Has a history of drug or alcohol abuse
* Has previously received calmangafodipir or mangafodipir
* Welders, mine workers, or other workers in occupations (current or past) where high manganese exposure is likely

Primary outcomes:
measure: Number of treatment-emergent adverse events
timeFrame: From signing of informed consent through the last follow up visit (up to Day 10)
Secondary outcomes:
measure: Cmax
timeFrame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
measure: tmax
timeFrame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
measure: AUC(0-last)
timeFrame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
measure: Ae
timeFrame: 4 hours post-dose and 24 hours post-dose
measure: Ae%
timeFrame: 4 hours and 24 hours post-dose
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global
state: California
Study officials:
References:
Clinical trial NCT03931499: Biochemical Predictors of Delirium in Cardiac Surgery
Official title: Biochemical Predictors of Delirium in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
Collaborators: name: Novosibirsk State University
First posted: 2019-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient undergoing cardiac surgery under cardiopulmonary bypass

Brief summary: Delirium is a common neurologic complication after cardiac surgery occuring in 30-50% of patients. The occurence of this complication is associated with worse outcomes, including prolonged length of stay in the ICU and hospital, increased morbidity and mortality. Considering great clinical significance of this complication, the search for early predictors of postoperative delirium remains an urgent task. The purpose of this prospective observational study is to test the hypothesis that metabolomic changes before and after cardiac surgery could be served as early predictors of this complication.


Eligibility criteria: Inclusion Criteria:

* surgery under cardiopulmonary bypass
* Age \> 60 years
* CABG surgery or valve surgery (repair/replacement)

Exclusion Criteria:

* urgent surgery
* surgery on aorta
* combined procedures (CABG+valves)
* significant stenosis of carotid arteries
* Parkinson's disease
* liver cirrhosis
* use of anticholinergic drugs, antidepressants, antiepileptic or chemotherapy drugs

Primary outcomes:
measure: Postoperative delirium
timeFrame: 5 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: E. Meshalkin National Medical Research Center
Study officials:
References:
Clinical trial NCT03129399: Comparison of King Vision Video Laryngoscope to McGrath MAC Video Laryngoscope for Nasal Intubation
Official title: Nasal Intubation Using the King Vision Video Laryngoscope:a Randomized,Controlled Comparison With McGrath MAC Video Laryngoscope
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasal Intubation
Keywords: anesthesia
King Vision
videolaryngoscope
nasotracheal
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to determine the comparison between the King Vision video laryngoscope and McGrath MAC video laryngoscope for nasotracheal intubation.Patients were divided into 2 groups of 40 patients each.Patients of King Vision group \[n=40\]and Macintosh group \[n=40\]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation in difficult airway.


Eligibility criteria: Inclusion Criteria:

* ASA physical status 1-2
* Scheduled for general anesthesia with nasotracheal intubation
* Cormach-Lehane score 3-4

Exclusion Criteria:

* contraindications to nasal intubation
* Patients with a history of anti-hypertensive drugs

Primary outcomes:
measure: time to intubation
timeFrame: 0 min after nasal intubation
Secondary outcomes:
measure: Hemodynamic changes
timeFrame: 1 min before general anesthesia induction
measure: Hemodynamic changes
timeFrame: 1 min after general anesthesia induction
measure: Hemodynamic changes
timeFrame: 3 min after general anesthesia induction
measure: Hemodynamic changes
timeFrame: 5 min after general anesthesia induction
measure: ease of intubation
timeFrame: 5 min after nasal intubation
measure: incidence of trauma
timeFrame: 24hour after surgery
measure: incidence of trauma
timeFrame: 1hour after surgery
measure: number of failures
timeFrame: 5 min after nasal intubation
measure: the degree of Cormach-Lehane
timeFrame: 5 min after nasal intubation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT00483899: Examine the Effect of Repeat Inhaled Doses of GW870086X on Lung Function in Mild Asthmatic Male Subjects
Official title: Double-blind, Placebo-controlled, 3-way Crossover Study to Investigate the Effect of 7-days Repeat Once Daily Inhaled Doses of GW870086X Administered Via DISKHALER on Airway Responsiveness to AMP in Mild Steroid-naive Male Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: GW870086X Asthma Crossover repeat dose inhaled
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to look at safety aspects and effects of repeat inhaled doses of GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic obstructive pulmonary disease (COPD)


Eligibility criteria: Inclusion criteria:

* Male subjects aged 18-55
* Documented history of bronchial asthma diagnosed at least 6 months ago.
* Only being treated with short-acting beta-2-agonist therapy e.g. Ventolin
* Documented sensitivity to adenosine mono phosphate (AMP) at screening visit
* Demonstrate repeatable and reproducable response to inhaled AMP at the run-in visit

Exclusion criteria:

* Any significant illness or disease
* History of life threatening asthma
* History of respiratory tract infection
* Subjects who take medication for their asthma, or other conditions, not compatible with this study.
* Smoker
* Subjects who are oversensitive to corticosteroids
* History of drug or alcohol abuse
* Donated blood within last 3 months
* Been involved in another clinical trial during the last 3 months
* Subjects who work night shifts
* Subjects who are undergoing de-sensitisation therapy

Primary outcomes:
measure: Change in lung function 2 hours after treatment on day 7
timeFrame: on day 7
Secondary outcomes:
measure: Change in lung function 14 and 26 hours after treatment on day 7; Change in lung function 2 hours after treatment on day 1; Effects on blood and urine tests; effects on the heart, pulse rate and blood pressure; effects on the lungs
timeFrame: 2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7;
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01267799: Health Status of Workers in Photocopier Units
Official title: Correlation Between Pulmonary Function and Selected Serum/Sputum Biomarkers of Pulmonary Damage Among Workers in Photocopier Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure to Photocopiers on a Professional Basis
Lead sponsor: Avinashilingam Deemed University
Sponsor class: OTHER
First posted: 2010-12-29
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: exposure to photocopier emissions

Brief summary: Photocopiers are indispensable in today's working environment. However, photocopiers emit a number of harmful chemicals during their operation. Photocopier toners also contain a number of potentially toxic substances. Chronic exposure to these substances may compromise the health of photocopier operators. This study is aimed to understand if chronic exposure to photocopier emissions is harmful to human health.


Eligibility criteria: Inclusion Criteria:

Exposure to photocopier emissions for minimum 2 years professionally

Exclusion Criteria:

Any clinical abnormality

Primary outcomes:
measure: To assess if photocopier emissions are toxic to human health
timeFrame: 2 years
Secondary outcomes:
measure: To assess the best biomarker for pulmonary damage in serum
timeFrame: 2 years
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: Avinashilingam Deemed University for Women
state: Tamilnadu
city: Coimbatore
country: India
facility: Avinashilingam Deemed University
state: Tamilnadu
city: Coimbatore
country: India
state: Tamilnadu
Study officials:
affiliation: Avinashilingam Deemed University for Women
name: Jeyanthi G P, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00772499: Vascular Improvement With Olmesartan Medoxomil Study
Official title: Vascular Improvement With Olmesartan Medoxomil Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare in patients with primary hypertension, the non-blood pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol on changes in the vascular structure and function.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18-75 years of age
* Mean seated diastolic BP 90-109 or mean seated systolic BP of 140-179

Exclusion Criteria:

* Secondary hypertension
* Renal disease
* Diabetes mellitus
* Serum creatinine \>3.0 mg/dL
* Hemoglobin \<10 mg/dL (males) or \<9mg/dL (females)
* WBC count \<2000 cells/mL
* Platelet count \<100,000 cells/mL
* Either ALT \& AST \>2.5 x upper limit of normal
* BMI \>35 kg/m2
* TIA or cerebrovascular attack within 3 months of study entry

Primary outcomes:
measure: Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy
timeFrame: 52 weeks
Secondary outcomes:
measure: Results of vascular function tests
timeFrame: 12 weeks
measure: Results of vascular function tests
timeFrame: 28 weeks
measure: Results of vascular function tests
timeFrame: 52 weeks
measure: Measurement of serum lipid and markers of atherosclerosis
timeFrame: 12 weeks
measure: Measurement of serum lipid and markers of atherosclerosis
timeFrame: 28 weeks
measure: Measurement of serum lipid and markers of atherosclerosis
timeFrame: 52 weeks
measure: Retinal arteriole measurements
timeFrame: 52 weeks
measure: Calculation of insulin sensitivity measurement
timeFrame: 12 Weeks
measure: Calculation of insulin sensitivity measurement
timeFrame: 28 weeks
measure: Calculation of insulin sensitivity measurement
timeFrame: 52 weeks
measure: 24 hour urine creatinine and thromboxane B2 measurements
timeFrame: 12 weeks
measure: Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio
timeFrame: 12 weeks
measure: Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio
timeFrame: 28 weeks
measure: Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT06826599: Agreement and Precision Study of UNITY® DX and a Comparator Biometer
Official title: Agreement and Precision Study of UNITY® DX and a Comparator Biometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Eyes
Abnormal Eyes
Keywords: Biometric measurements
Lead sponsor: Cylite Pty Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 160
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohorts will be selected from approximately one investigative site located in the United States.

Brief summary: The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of the biometric measurements will be evaluated.

Detailed description: This is intended to be a 1-visit study approximately 3 hours in length with planned duration of exposure of up to 20 minutes per device (investigational biometer and IOLMaster 700). Four cohorts will be enrolled. One eye per subject will be assessed.

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an Institution Review Board approved Informed Consent form.
* Willing and able to attend all scheduled study visits as required by the protocol.
* Identified by the investigator as eligible for at least one of the 4 eye groups identified in the protocol.

Exclusion Criteria:

* Unable to fixate, for example, due to nystagmus or other eye movement abnormality.
* Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
* Active ocular infection or inflammation.
* Rigid or contact lens wear during the previous two weeks prior to Screening.

Primary outcomes:
measure: Central corneal thickness (CCT)
timeFrame: Day 1
measure: Lens thickness (LT)
timeFrame: Day 1
measure: Anterior chamber depth (regression) (ACD-R)
timeFrame: Day 1
measure: Axial length (regression) (AL-R)
timeFrame: Day 1
Secondary outcomes:
measure: Anterior Chamber Depth Sum of Segments (ACD-SoS)
timeFrame: Day 1
measure: Axial Length Sum of Segments (AL-SoS)
timeFrame: Day 1
Other outcomes:
Locations:
city: Woburn
country: United States
facility: NorthEast Eye Research Associates LLC
state: Massachusetts
Study officials:
affiliation: Cylite Pty Ltd
name: Arnold Ouyang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04591899: Clinical and Radiographic Outcomes of CAD/CAM vs Conventionally Constructed Occlusal Splints in Patients With Temporomandibular Joint Disorders
Official title: Clinical and Radiographic Outcomes of CAD/CAM Versus Conventionally Constructed Occlusal Splints in Patients With Temporomandibular Joint Disorders: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare between digitally formed occlusal splints versus conventional occlusal splints in patients with TMDs regarding patient satisfaction


Eligibility criteria: Inclusion Criteria:

- Patients' age ranging from 20 to 50 years.

TMDs according to the research diagnostic criteria (RDC) for TMD (RDC/TMD) and magnetic resonance imaging (MRI) for confirmation which include:

i. Painful TMJ audible and palpable click. ii. No functional mouth limitation. iii. TMJ tenderness. Fully dentate patients without any malocclusion and good oral hygiene. Co-operative patient that should show motivation to follow up.

Exclusion Criteria:

* Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, Myasthenia Gravis and fibromyalgia.
* Patients showing bony irregularities e.g. osteophyte as recorded by Magnetic resonance imaging.
* Patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results.
* Any condition that contra-indicates MRI such as patients with pacemakers in heart.
* Patients with removable dental prosthesis

Primary outcomes:
measure: Patient Satisfaction, done by questionnaire having the visual analogue scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: