louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02049879: Daily Activity After Corticosteroids Injection Among Knee Osteoarthritis Patients
Official title: Quantification of Daily Physical Activity After an Intra-articular Corticosteroid Injection in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study was to objectively measure daily physical activity and spatiotemporal gait pattern, as well as improvements in self reported symptoms and quality of life, before and six weeks after an intra-articular corticosteroids injection in patients suffering from knee osteoarthritis. Fourteen patients with unilateral knee osteoarthritis were recruited. The intra-articular corticosteroid injection was given at the end of the second week. Physical activity was objectively measured by an accelerometer worn by the participants for eight weeks. In addition, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Medical Outcome Study Short Form-36 (MOS-SF36) and gait trials were completed every two weeks to assess symptoms, quality of life and spatiotemporal parameters of gait.


Eligibility criteria: Inclusion Criteria:

* 50 years old or more
* Medial knee osteoarthritis (Kellgren \& Lawrence Grade I to III)

Exclusion Criteria:

* Intra-articular injection during the last six months
* Isolated femoro-patellar arthritis
* Rheumatoid arthritis
* Knee instability
* Spinal stenosis
* Lower limb fracture over the last year
* Lower limb surgery in the last three months

Primary outcomes:
measure: Change in Knee pain
timeFrame: Change from Baseline at 2, 4 and 6 weeks
measure: Change in physical activity
timeFrame: Change from baseline at 2, 4 and 6 weeks
Secondary outcomes:
measure: Change in function and quality of life
timeFrame: Change from baseline at 2, 4 and 6 weeks
measure: Change in Spatiotemporal gait parameters
timeFrame: Change from Baseline at 2, 4 and 6 weeks
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Pavillon de l'Éducation Physique et des Sports - Université Laval
Study officials:
affiliation: Laval University
name: Philippe Corbeil, PhD
role: STUDY_DIRECTOR
affiliation: Laval University
name: Yoann Dessery, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Étienne Belzile, MD
role: STUDY_DIRECTOR
References:
citation: Dessery Y, Belzile EL, Turmel S, Dore J, Diallo B, Corbeil P. Modulation of physical activity to optimize pain sensation following an intra-articular corticosteroid injection in patients with knee osteoarthritis. ScientificWorldJournal. 2014;2014:209165. doi: 10.1155/2014/209165. Epub 2014 Nov 16.
Clinical trial NCT00857779: Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients
Official title: A Multicentre Randomised Phase II Clinical Trial to Demonstrate Equivalent Pharmacodynamic Efficacy and Tolerability of Two Updosing Schedules for ALK-Flex SQ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis
Conjunctivitis
Asthma
Keywords: allergen immunotherapy
allergy to grass pollen
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 473
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: TREATMENT

Brief summary: The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ


Eligibility criteria: Inclusion Criteria:

* A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
* Lack of adequate relief with symptomatic medication during the previous grass pollen season
* Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter \>= 3mm) currently performed or not older than 60 days before screening

Exclusion Criteria:

* FEV1 \< 70% of predicted value at screening
* Bronchial asthma corresponding to GINA step 3 or more, even if controlled
* History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months
* Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
* Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ

Primary outcomes:
measure: IgE-blocking factor
timeFrame: start of treatment and 1 week after end of treatment
Secondary outcomes:
measure: Tolerability of two different updosing schedules
timeFrame: throughout treatment
Other outcomes:
Locations:
city: Erfurt
country: Germany
facility: Allergists' practice Dr. Kirsten Jung
state: Thueringen
Study officials:
affiliation: Private practice, Erfurt, Germany
name: Kirsten Jung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfaar O, Jung K, Wolf H, Decot E, Kleine-Tebbe J, Klimek L, Wustenberg E. Immunological effects and tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with optimized allergen/adjuvant ratio. Allergy. 2012 May;67(5):630-7. doi: 10.1111/j.1398-9995.2012.02801.x. Epub 2012 Mar 3.
Clinical trial NCT06655779: Performance of the Acoustic Based CADScor System in Coronary Artery Disease
Official title: Performance of the Acoustic Based CADScor System in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Angina (stable)
Keywords: CADScore
Lead sponsor: INTEGRIS Baptist Medical Center
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects to be recruited from INTEGRIS Baptist Medical Center.

Brief summary: The purpose of this study is to determine if the CAD Score, collected from the CADscore system, performs as well as the Coronary CTA in determining Coronary Artery Disease, in low to intermediate risk patients that are referred for coronary CTA.


Eligibility criteria: Inclusion:

* Signed ICF
* Male or female, aged 30 years or above
* Symptoms suggestive of stable coronary artery disease
* No history of coronary artery disease(prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).

Exclusion:

* Asymptomatic for angina or chest pain
* Implanted donor heart
* Previous Coronary Artery Bypass Graft(CABG)
* Previous Coronary Stenting or known CAD
* Arrhythmia causing non-sinus rhythm
* Fragile or compromised skin, or abnormal anatomy or significant operation scars in the fourth left int3er Costal 9IC4-L) recording area
* Implanted mechanical heart or mechanical heart pump
* Implanted pacemaker or Cardioverter Defibrillator(ICD), other implanted active electronics or act5ive electronic support equipment closer than 50 cm to the CADScore System.

Primary outcomes:
measure: Primary Objective
timeFrame: From enrollment through 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
Study officials:
affiliation: INTEGRIS Baptist Medical Center
name: Jon P Blaschke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004779: Phase I Pilot Study of Ad5-CB-CFTR, an Adenovirus Vector Containing the Cystic Fibrosis Transmembrane Conductance Regulator Gene, in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of North Carolina
First posted: 2000-02-25
Enrollment: 12
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Assess the safety and efficacy of gene transfer into the nasal epithelium using Ad5-CB-CFTR, an E1-deleted adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, in patients with cystic fibrosis (CF).

II. Determine whether ion transport abnormalities in CF airway cells can be corrected.

Detailed description: PROTOCOL OUTLINE:

Groups of 3 patients receive 1 of 4 doses of Ad5-CB-CFTR, a recombinant E1-deleted adenovirus serotype 5 vector containing the cystic fibrosis transmembrane conductance regulator gene. Ad5-CB-CFTR is administered to 1 nasal cavity and the vehicle alone is administered to the opposite nasal cavity as the control.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Cystic fibrosis No mild genetic mutations, i.e., normal nasal chloride ion permeability At least 2 weeks since decrease in pulmonary function --Prior/Concurrent Therapy-- At least 3 months since systemic cortisone At least 1 month since other therapeutic research study, e.g., DNAse --Patient Characteristics-- Other: Adequate endocrine, liver, kidney, and cardiac function Adenovirus antibody seropositive No pregnant or nursing women Negative pregnancy test required of fertile women Adequate contraception required of fertile patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina
name: Michael R. Knowles
role: STUDY_CHAIR
References:
Clinical trial NCT01281579: A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers
Official title: An Open-Label, Randomized, Parallel-Group, Single-Center Study to Evaluate the Single and Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Pharmacodynamics
Canagliflozin
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 27
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: The purpose of this study is to determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin.

Detailed description: This is an open-label (volunteers and study staff will know the name and dose of the treatment assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM). Healthy volunteers will take canagliflozin 50 mg, 100 mg, or 300 mg tablets, orally (by mouth), once daily on Day 1 and on Days 4 to 9. All study drug administration will occur at approximately the same time each morning with 240 mL of noncarbonated water and will be followed by a standardized breakfast within 10 minutes.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
* Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin

Primary outcomes:
measure: Plasma concentrations of canagliflozin
timeFrame: At protocol-specified times up to Day 14
measure: Urine concentrations of canagliflozin
timeFrame: At protocol-specified times up to Day 11
measure: Plasma glucose concentrations
timeFrame: At protocol-specified times up to Day 11
measure: Urine glucose concentrations
timeFrame: At protocol-specified times up to Day 11
Secondary outcomes:
measure: The number and type of adverse events reported
timeFrame: Up to 10 days after last dose" (last dose is given on Day 9)
measure: Changes in hematology, chemistry and urinalysis parameters
timeFrame: Up to 10 days after last dose" (last dose is given on Day 9)
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT05182879: Evaluation of Frail Elderly in Ambulatory Primary Care
Official title: Evaluation of Frail Elderly in Ambulatory Primary Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 740
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly independent population

Brief summary: Evaluate the sensitivity of the GERONTOPOLE scale, used by general practitioners in primary care outpatients for the diagnosis of frailty in non-dependent people more than 65 years old, using as reference the "évaluation gériatrique standardisée clinique" (EGS)


Eligibility criteria: Inclusion Criteria:

* Independent patients

Exclusion Criteria:

* Dependent outpatient, assessed with a "activity of daily living" (ADL) score \< 6/6
* outpatient with occuring severe health episode less than a month before inclusion

Primary outcomes:
measure: assess the sensitivity of the GERONTOPOLE scale
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU Lille
state: Nord
Study officials:
affiliation: University Hospital, Lille
name: Nassir MESSAADI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05916079: Breastfeeding Failure: Influence of Smartphone Use and Distraction Factors
Official title: Breastfeeding Failure: Influence of Smartphone Use and Distraction Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breastfeeding
Smartphone
Keywords: Breastfeeding
smartphone
screen
distraction
developmental care
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breastfeeding mothers of Newborn breastfed infant born in the maternity ward of the Amiens-Picardie University Hospital

Brief summary: The benefits of breastfeeding no longer need to be proven. Many studies have shown its positives effects on both infants and mothers. Exclusive breastfeeding is thus recommended within the first six months of life.

Excessive screen use has been shown to be harmful in many aspects of daily life. The impact upon the relation between mother and newborn infant is poorly studied.

The study aims to evaluate the impact of the use of smartphones on the success and duration of breastfeeding.


Eligibility criteria: Inclusion Criteria:

* breastfeeding mothers of Newborn breastfed infant born in the maternity ward of the Amiens-Picardie University Hospital

Exclusion Criteria:

* Mother refusing to participate in the study; hospitalization during the neonatal period

Primary outcomes:
measure: Variation of Breastfeeding status in both groups
timeFrame: at 2 months
measure: Variation of Breastfeeding status in both groups
timeFrame: at 3 months
measure: Variation of Breastfeeding status in both groups
timeFrame: at 4 months
measure: Variation of Breastfeeding status in both groups
timeFrame: at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
state: Picardie
Study officials:
References:
Clinical trial NCT00610779: Treatment of Acute Rhino-Sinusitis With Essential Oils of Aromatic Plants
Official title: Treatment of Acute Rhino-Sinusitis With Essential Oils of Some Aromatic Medical Plants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rhino-Sinusitis
Keywords: Rhino-sinusitis;
Herbal medicine;
Traditional medicine;
Aromatic essential oils;
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 14
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: This randomized, double blind, parallel group study, compared the efficacy of spray containing aromatic essential oils of some herbal plants, against placebo in the treatment of patients with acute Rhino-sinusitis.

Study objectives: Primary to demonstrate a relief in the nasal obstruction within 20 minutes after first administration of treatment with the spray.

Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment

Detailed description: This study compared the efficacy of spray containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, against placebo in the treatment of patients with acute Rhino-sinusitis.

In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Rhino-sinusitis. The pharmacological and clinical activity of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, include anti-inflammatory, anti-bacterial and anti-viral activities. Some of these herbs and trees oils have direct activity on the respiratory tract, the coughing reflex and the airflow in the nasal tract.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute Rhino-sinusitis.
* Active disease less than 96 hours
* Patients agree to sign informed consent according to GCP and Israel national regulations.

Exclusion Criteria:

* Acute Sinusitis that need to get an antibiotically treatment .
* Nasal polyposis.
* Under any antibiotically treatment.
* Asthma disease.
* Under coumadine therapy.
* Hyper sensitivity to Aromatic essential oils.
* Any immuno-suppressive disease

Primary outcomes:
measure: To demonstrate a relief in the nasal obstruction within the first 20 minutes after first administration of treatment with the spray.
timeFrame: 20 minutes
Secondary outcomes:
measure: To demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment.
timeFrame: 3 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Otorhinolaryngology department
Study officials:
affiliation: haemek medical center
name: Yoseph Rakover, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03595579: Assessing Symptomatic Clinical Episodes in Depression
Official title: A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: AXS-05
Major Depressive Disorder
MDD
Axsome
Depression
Dextromethorphan
Bupropion
Sigma-1
NDMA
ASCEND
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 97
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: TREATMENT

Brief summary: Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

Detailed description: This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.

Eligibility criteria: Inclusion Criteria:

* Currently meets DSM-5 criteria for MDD
* Body mass index (BMI) between 18 and 40 kg/m\^2, inclusive
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Suicide risk
* History of treatment resistance in current depressive episode
* History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
* Additional criteria may apply

Primary outcomes:
measure: MADRS Score - Overall Change From Baseline
timeFrame: Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)
Secondary outcomes:
Other outcomes:
measure: MADRS Score - Change From Baseline to Week 6
timeFrame: 6 weeks
Locations:
city: Beverly Hills
country: United States
facility: Clinical Research Site
state: California
city: Jacksonville
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Bellevue
country: United States
facility: Clinical Research Site
state: Washington
Study officials:
References:
citation: Tabuteau H, Jones A, Anderson A, Jacobson M, Iosifescu DV. Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial. Am J Psychiatry. 2022 Jul;179(7):490-499. doi: 10.1176/appi.ajp.21080800. Epub 2022 May 18.