louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01101932: Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers
Official title: A Phase 1, Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04308515 (Part 1), And A Single Dose Pharmacokinetic Assessment Of A PF-04308515 Tablet Formulation (Part 2), In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics/Pharmacodynamics
Rheumatoid Arthritis
healthy volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04308515 in healthy volunteers for 14 days as well as one oral dose of a tablet formulation administered for 1 day.


Eligibility criteria: Inclusion Criteria:

* Healthy males between 18 and 55 years, inclusive
* Healthy females between 18 and 44 years, inclusive
* Females are required to be surgically sterile

Exclusion Criteria:

* Evidence or history of clinically significant disease
* Post-menopausal women
* History of intolerance or significant adverse effects with glucocorticoid therapy

Primary outcomes:
measure: Safety and tolerability of multiple doses of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs).
timeFrame: 14 days
measure: Characterization of pharmacokinetic parameters of PF-04308515 after multiples doses which will include: Cmax, Tmax, AUC, CL/F, Vz/F, t1/2. Urinary excretion including AE% and CLr will be assessed at steady state.
timeFrame: 14 days
measure: Change from baseline will be utilized to assess PF-04308515's pharmacodynamic effect on biochemical and metabolic biomarkers after 14 days of dosing.
timeFrame: 14 days
measure: For the tablet pharmacokinetics:Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, t1/2 will be calculated from the PF-04308515 plasma concentration versus time data.
timeFrame: 1 day
measure: Safety and tolerability of 1 oral dose of a tablet formulation of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs).
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02534532: Atrial Fibrillation Screening With a Smartphone Device and iECG Application
Official title: Atrial Fibrillation Screening With a Smartphone Device and iECG Application
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation screening
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects included in the study are patients 65 years and older reaching programmed primary care counselling, and who are willingly to participate and do not present any exclusion criteria for the screening

Brief summary: Question: Can atrial fibrillation (AF) cases in patients ≥ 65 years be easily detected in a primary healthcare environment using a smartphone device and iECG application as an opportunistic screening tool?

Objectives:

Detection of AF through cardiac rhythm abnormalities in patients ≥65 years old in an opportunistic screening program using a smartphone device/application

1. Define the predictable value of the smartphone device with electrocardiogram (ECG) confirmation to detect AF in patients 65 years and older
2. Correlate screened patients cardiovascular risk profile and those that register cardiac rhythm irregularities for a better description of the general characteristics of Colombian population


Eligibility criteria: Inclusion Criteria:

* Females and males patients ≥65 years old attending primary care counselling
* Written informed consent

Exclusion Criteria:

* Patients with confirmed diagnosis of AF
* Patients who do not want to participate
* Patients consulting for acute conditions
* Patients presenting any diagnosed arrhythmia different than AF

Primary outcomes:
measure: Number of patients screened in whom the screening device detect an abnormal cardiac rhythm
timeFrame: Up to 6 months
measure: Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECG
timeFrame: Up to 6 months
Secondary outcomes:
measure: Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECG
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01489137: The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation
Official title: The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation in the Patients Undergoing Neurosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
AVM
ICH
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic changes to head fixation in the patients undergoing neurosurgery.


Eligibility criteria: Inclusion Criteria:

* patients undergoing neurosurgery that require head fixation with mayfield head holder
* patients who agree to our study

Exclusion Criteria:

* patients who don't agree to our study
* BMI\<16.0 or BMI\>30
* cardiovascular disease, pulmonary disease, renal disease
* alcoholic abuser or drug abuser
* patients who takes any drug having an influence on cardiovascular system or sympathetic nervous system
* any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction to peri-fixation period

Primary outcomes:
measure: mean arterial blood pressure
timeFrame: peri-fixation periord
measure: heart rate
timeFrame: peri-fixation periord
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Lee JM, Bahk JH, Lim YJ, Lee J, Lim L. The EC90 of remifentanil for blunting cardiovascular responses to head fixation for neurosurgery under total intravenous anesthesia with propofol and remifentanil based on bispectral index monitoring: estimation with the biased coin up-and-down sequential method. BMC Anesthesiol. 2017 Oct 10;17(1):136. doi: 10.1186/s12871-017-0426-z.
Clinical trial NCT04736537: A Study to Evaluate 4DCT Controls
Official title: 4DCT Wrist Biomarkers During Resisted and Unresisted Tasks in Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrist Ligament and Bone Disorders
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2021-02-03
Enrollment: 31
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: BASIC_SCIENCE

Brief summary: The purpose of this study is to use CT motion pictures (4DCT) to visualize and record how much space there is between certain wrist joint bones, both without any resistance and with light resistance to the movement, during a single scanning visit.


Eligibility criteria: Inclusion Criterion:

* Age ≥ 18 and ≤ 60 years.
* Control subjects without any history of wrist injury or disease.

Exclusion Criteria (applied to both wrists for control subjects):

* Previously-diagnosed rheumatological conditions or connective tissue diseases;
* Inability to be appropriately positioned in the scanner for the imaging;
* Congenital malformations of the wrist or forearm;
* Diagnosed wrist osteoarthritis
* Age under 18 or over 60.

Primary outcomes:
measure: Scapholunate (SL) Gapping
timeFrame: Baseline
measure: Radioscaphoid (RS) Gapping
timeFrame: Baseline
measure: Radiolunate (RL) Gapping
timeFrame: Baseline
Secondary outcomes:
measure: Scaphotrapezium (STm) Gapping
timeFrame: Baseline
measure: Scaphotrapezoid (STd) Gapping
timeFrame: Baseline
measure: Trapezoitrapezoid (TmTd) Gapping
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kristin D. Zhao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04438252: Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions
Official title: Evaluation of Reliability of Impedance Spectroscopy (CarieScan PRO) in Comparison With Digital Radiograph and ICDAS-II in Detection of Occlusal Carious Lesions: Diagnostic Accuracy Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 166
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the Clinical performance of alternating current impedance spectroscopy (CarieScan PRO) in comparison with digital radiograph and ICDAS-II in detection of occlusal carious lesions.

Detailed description: The visual examination is routinely used for detecting caries in dental clinics and was also used in recent studies comparing the efficacy of various visual aids. It has the benefit that it is quick and easy to perform, does not need expensive equipment, and can be completed without unnecessary radiation or fluorescence (Ismail, et al., 2007). In the current study, ICDAS-II was set as "gold standard" due to validated relationship between its codes and the histological depth of a carious lesion as in many other studies. In addition, several studies have shown good reproducibility and accuracy of ICDAS-II for caries detection in permanent teeth especially caries lesions in the outer half of the enamel (Gugnani, et al., 2010). Bitewing radiographs are used to determine the depth of caries involvement. Most often, bitewing examination is affiliated with the diagnosis of interproximal caries. It is strongly recommended that these radiographs be used in the diagnosis of occlusal caries into dentin (Pitts NB et al., 1991).

Eligibility criteria: Inclusion Criteria of teeth:

* Posterior teeth with dark shadow on occlusal surface.
* Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
* Intact contact with opposing teeth.
* Teeth with no previous restorations in other surfaces.

Exclusion criteria of the teeth:

* Periapical pathology or signs of pulpal pathology.
* Tooth hypersensitivity.
* Possible prosthodontic restoration of teeth.
* Heavy occlusion and occlusal contacts or history of bruxism.
* Severe periodontal affection.

Primary outcomes:
measure: Dental Caries
timeFrame: slow study completion in average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty Of Dentistry
Study officials:
affiliation: Cairo University
name: Olfat ElSayed Hassanien, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00565552: Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage
Official title: Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cicatrix, Hypertrophic
Keloid
Keywords: silicone gel
cicatrix
wound healing
scar
keloid
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2007-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: So far the evaluation of scar treatment was based on subjective criteria. The patient groups were divided into treated versus non-treated.

In this study we use patients undergoing ear reconstruction with autologous rib cartilage. The thoracic scar of harvesting the rib cartilage is routinely reopened after 3 month during second stage of reconstruction. Therefore we have a ideal model of clinical, physiological and histological scar evaluation in a homologous patient group.

All patients randomly treat one half of the scar with a silicone gel (Dermatix). The other half is untreated as an internal control.


Eligibility criteria: Inclusion Criteria:

* patients with high grade microtia requiring a reconstruction with autologous rib cartilage

Exclusion Criteria:

* diabetes mellitus
* vascular disease
* known allergic reaction to silicone

Primary outcomes:
measure: Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.)
timeFrame: 45 minutes
Secondary outcomes:
measure: allergic reaction compliance
timeFrame: retrospective
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: University Hospital Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Stefan Nitsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05482152: Nurse-led Pain Education Clinical Trial in Chronic Pain Patients
Official title: Effect Van Preklinische Nurse-led Neuroscience Pijneducatie op de Attituden Ten Opzichte Van Chronische Pijn en de patiënttevredenheid in Een Universitair Pijncentrum: Een Monocentrische RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2022-08-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic pain is a multidimensional problem that consequently requires interventions on multiple levels. Pain education by physicians is one of the interventions that shows promising results in patient reported outcomes. It is however unclear if nurse-led chronic pain education could be equally effective on pain attitude and behavior in chronic pain patients. The aim of this clinical trial is to investigate the effects of a nurse-led consultation with chronic pain patients on pain attitude and patient satisfaction compared with regular care without nurse specialist intervention.


Eligibility criteria: Inclusion Criteria:

* 18 years old
* dutch speaking
* first time consultation

Exclusion Criteria:

* Palliative care patients
* Patients with dementia diagnosis
* Urgent referral to the pain clinic by other physicians

Primary outcomes:
measure: Patient attitude on chronic pain
timeFrame: Up to 10 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Bart Morlion, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01370252: Arthroscopic Ankle Arthrodesis: Measuring Post-operative Pain to Assess the Potential for Outpatient Surgery.
Official title: Arthroscopic Ankle Arthrodesis: Measuring Post-operative Pain to Assess the Potential for Outpatient Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Keywords: ankle arthrodesis
pain
arthroscopic technique
ankle osteoarthritis
Lead sponsor: Hammond, Allan, M.D.
Sponsor class: INDIV
First posted: 2011-06-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients selected from the surgeons waitlist.

Brief summary: Post-operative pain will be measured using a pain diary for one week post-surgery. The purpose is to test the assumption that the arthroscopic technique leads to less post-operative pain and results in shorter hospital stays when compared to the open technique. It is believed that the arthroscopic technique will result in minimal pain when compared to the open technique, allowing this procedure to be performed as day surgery.


Eligibility criteria: Inclusion Criteria:

* Ankle osteoarthritis with adequate bone stock

Exclusion Criteria:

* Mental or physical inability to consent or answer pain questions, pre-operative or peri-operative morbidity impairing mobility, pre-operative opioid therapy, non-steroidal anti-inflammatory drugs or steroids within 24 hours before skin incision, kidney or liver dysfunction, morbid obesity, smoking, significant bony deformity, significant loss of bone stock or diabetes with sensory changes will be cause for exclusion.

Primary outcomes:
measure: Numeric Rating Pain Scale (NRPS)
timeFrame: recorded for one week post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba, Faculty of Medicine, Department of Orthopedics, Assistant professor
name: Allan Hammond, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01865552: Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
Official title: A Randomised, Single-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel® and US Sourced Enbrel®) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-05-31
Enrollment: 138
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.

Detailed description: * Part A: Comparison between SB4 and EU sourced Enbrel
* Part B: Comparison between SB4 and US sourced Enbrel
* Part C: Comparison between EU sourced Enbrel and US sourced Enbrel

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* Have a body weight between 60 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.

Exclusion Criteria:

* history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.
* active or latent Tuberculosis or who have a history of TB.
* history of invasive systemic fungal infections or other opportunistic infections
* systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
* serious infection associated with hospitalisation and/or which required intravenous antibiotics
* history of and/or current cardiac disease
* have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
* Intake medication with a half-life \> 24 h within 1 month or 10 half-lives of the medication prior to the first administration of IP.

Primary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
timeFrame: 0 to 480 hours post-dose
measure: Maximum Serum Concentration (Cmax)
timeFrame: 0 to 480 hours post-dose
Secondary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
timeFrame: 0 to 480 hours post-dose
measure: Time to Cmax (Tmax)
timeFrame: 0 to 480 hours post-dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Parexel
name: Rainard Fuhr, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06420752: Passive Stretching in Peripheral Arterial Disease Patients
Official title: Passive Stretching and Dietary Nitrate Rescue Functional Capacity in Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Peripheral Arterial Disease
Walking, Difficulty
Inflammation
Keywords: Cardiovascular
Lead sponsor: University of Wisconsin, La Crosse
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peripheral artery disease (PAD) leads to higher mortality rates and strains healthcare systems due to increased costs. It causes leg pain during walking due to reduced blood flow. Nitric oxide (NO) deficiency contributes to vascular issues in PAD, with few effective treatments available. Passive calf muscle stretching boosts NO levels, vascular health, and walking ability in PAD patients. However, the inflammatory processes underlying these improvements are unclear. This study aims to track inflammatory markers and cardiovascular changes during 12 weeks of passive stretching. Additionally, combining stretching with dietary nitrate could further enhance walking capacity by reducing reactive oxygen species. The study will monitor inflammation, vascular function, and oxidative capacity to understand the effects on functional ability in PAD patients. This research is crucial for improving physical function and addressing exercise intolerance in PAD.


Eligibility criteria: Inclusion Criteria:

Ankle-brachial index of 0.90 or less Stable condition for at least 3 months

Exclusion Criteria:

Habitual exercise or cardiovascular rehabilitation program during the past 3 months Critical limb ischemia, amputation, or leg pain at rest Major surgery or lower extremity revascularization in the last 3 months Heart Failure Kidney disease Beet allergy Crohn's Current smoker

Primary outcomes:
measure: Functional capacity
timeFrame: 12-14 weeks
Secondary outcomes:
measure: Inflammatory markers
timeFrame: 12-14 weeks
measure: Vascular function
timeFrame: 12-14 weeks
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: University of Wisconsin La Crosse
state: Wisconsin
Study officials:
affiliation: Assistant Professor
name: Jacob T Caldwell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: