louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00790049: A Safety Study of ARRY-371797 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Day And Multiple Day Ascending Dose Study To Evaluate The Safety And Pharmacokinetics Of Orally Administered ARRY-371797 In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Array BioPharma
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a Phase 1 study, involving both 1-day and 8-day dosing periods, designed to test the safety of investigational study drug ARRY-371797 in healthy subjects. Approximately 48 healthy subjects from the US will be enrolled in this study.


Eligibility criteria: Key Inclusion Criteria:

* Healthy male or female between the ages of 18 and 60 years.
* Females must be of nonchildbearing potential.
* Body weight \> 50 kg (110 lbs) and \< 113 kg (250 lbs).
* Additional criteria exist.

Key Exclusion Criteria:

* A positive test for drugs or alcohol.
* Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.
* Additional criteria exist.

Primary outcomes:
measure: Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
timeFrame: Duration of study
measure: Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
timeFrame: Duration of study
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I Clinic
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02212249: Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis
Official title: Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Raynaud Disease
Systemic Sclerosis
Keywords: soluble VE-cadherin
antibody
systemic slerosis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune disease with a endothelial dysfunction. This study is to evaluated the level of soluble VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.


Eligibility criteria: Inclusion Criteria:

* group 1: systemic sclerosis
* group 2: raynaud primary disease

Primary outcomes:
measure: Level of soluble Ve-cadherin and antibody VE-cadherin with ELISA TEST in Scleroderma group versus Primary Raynaud's Phenomenon
timeFrame: At 30 days average
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
References:
Clinical trial NCT04002349: Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis
Official title: Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Determination of the Efficacy of Different Medications for Idiopathic Rhinitis
Impact of Different Medications on Biomarkers of Idiopathic Rhinitis
Safety and Tolerance of Different Medications for Idiopathic Rhinitis
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Institute of Otolaryngology
name: Shanghai Johnson & Johnson Pharmaceuticals, Ltd.
First posted: 2019-06-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic rhinitis (CR) is one of the most common nasal mucosal diseases in the world. In China, about 140 million people suffer from this disease. Chronic rhinitis can lead to severe economic and social burden, as well as the potential risk of developing other chronic diseases such as asthma and chronic sinusitis. Therefore, it is of great significance to explore the classification and treatment strategies of chronic rhinitis in order to improve the health level of Chinese people.


Eligibility criteria: Inclusion Criteria:

* Not younger than 18 years old
* Diagnosed as idiopathic rhinitis
* Signed and volunteered for the study

Exclusion Criteria:

* Comorbid airway diseases including (but not limited to) upper airway infection, chronic rhinosinusitis, nasal polyps
* Allergic to the medicines about to study
* Having used oral glucocorticoids or antihistamine agents within 30 days of the enrollment

Primary outcomes:
measure: Relief of bothersome symptoms
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Beijing
country: China
facility: Yifan Meng
state: Beijing
Study officials:
References:
Clinical trial NCT03179449: In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI
Official title: MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Childhood Brain Neoplasm
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a noninvasive imaging biomarker of inflammation.

Detailed description: PRIMARY OBJECTIVE:

I. To establish the magnetic resonance (MR) imaging signal characteristics of macrophages in pediatric patients (\>= 2 years old) with newly diagnosed malignant brain tumors using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle.

SECONDARY OBJECTIVES:

I. To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of macrophages in surgical tumor specimen at histopathology.

OUTLINE:

Patients receive a single intravenous infusion of ferumoxytol over 15 minutes. After 24 hours, patients undergo ferumoxytol-enhanced magnetic resonance imaging (MRI). Patients will then undergo MRI-localized tissue sampling and tumor resection.

Eligibility criteria: Inclusion Criteria:

* Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection

Exclusion Criteria:

* Informed consent cannot be obtained either from the patient or legal representative
* Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
* Contraindication to MRI (metal implants)
* Hemosiderosis/hemochromatosis
* Iron overload from any cause (not just hemosiderosis or hemochromatosis), even if secondary to frequent blood transfusions, severe chronic hemolysis, excess dietary or parenteral iron, or any other etiology
* Known hypersensitivity to ferumoxytol or any of its components
* Pregnant patients

Primary outcomes:
measure: Iron concentration measurements
timeFrame: Day 1
Secondary outcomes:
measure: Macrophages on histopathology
timeFrame: Days 2-4
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Michael Iv
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03361449: Effect of Flamingo Exercises on Balance
Official title: Effect of Flamingo Exercises on Balance in Patients With Balance Impairment Due to Senile Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Gait Disorders, Neurologic
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of flamingo exercise on balance in patients with balance impairment due to senil osteoarthritis

Detailed description: Changes in the sensory, neurological, and musculoskeletal systems in older adults affect several motor tasks,including postural balance. Also osteoarthritis contribute to this process. Older people can gain balance disorders. The flamingo balance exercise is a full lower body workout utilizing many major muscle groups. Therefore investigators aimed to determine the effect of flamingo exercise combined with kinesthetic ability trainer or alone in patients with balance impairment due to osteoarthritis

Eligibility criteria: Inclusion Criteria:

* Older than 65 years old
* osteoarthritis diagnosis
* Balance impairment (Berg balance scale 21-40 points)

Exclusion Criteria:

* Severe neurological deficit
* Defect of vision
* Vitamin B12 deficiency
* Sedative drug use

Primary outcomes:
measure: kinesthetic ability trainer static score
timeFrame: 4 weeks
measure: kinesthetic ability trainer static dynamic score
timeFrame: 4 weeks
measure: Berg Balance Scale
timeFrame: 4 weeks
measure: Timed up and Go test
timeFrame: 4 weeks
measure: activity specific balance scale.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02147249: Cytokines and Chemokines in Erythema Migrans
Official title: Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erythema Migrans
Keywords: erythema migrans
Lyme borreliosis
inflammation
outcome
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
name: Medical University of Vienna
name: Harvard University
First posted: 2014-05-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.


Eligibility criteria: Inclusion Criteria:

* erythema migrans in patients \> 18 years

Exclusion Criteria:

* pregnancy or lactation
* taking antibiotic with antiborrelial activity within 10 days

Primary outcomes:
measure: inflammatory proteins in erythema migrans patients
timeFrame: up to 12 months follow-up
Secondary outcomes:
measure: gene polymorphisms in erythema migrans patients
timeFrame: at enrollment
Other outcomes:
measure: transcriptome profiles in erythema migrans patients
timeFrame: at 6 month follow-up
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana, Department of Infectious Diseases
Study officials:
affiliation: UMC Ljubljana
name: Franc Strle, MD, PhD
role: STUDY_CHAIR
affiliation: UMC Ljubljana
name: Dasa Stupica, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04739449: '4C' Intervention to Reduce SARS-CoV-2 (Covid-19) Transmission
Official title: '4C' Intervention to Reduce SARS-CoV-2 Transmission: Coaching, Cleaning, Communication and Collaboration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: SARS-CoV Infection
Covid19
Keywords: Environmental Contamination
Nursing Home
Interventions
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will have a cluster-randomized design in which two of the four nursing homes will be randomized to the intervention arm or the control arm.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Nursing homes have long faced special challenges in implementing effective infection prevention programs, including limited resources and diagnostic challenges in a frail functionally disabled long-stay population. Advancing our understanding of the transmission of SARS-CoV-2 within these facilities for vulnerable populations deserves urgent and further investigation. Environmental contamination with SARS-CoV-2 that is reported in limited studies highlights the potential importance of transmission between patients, their environment, and healthcare providers via direct and indirect contact.

This study seeks to characterize the epidemiology of SARS-CoV- 2 in the NH patient room environment over time and the risk of transmission to near and far environments, with the explicit intent of developing integrated, simple COVID-19 infection prevention strategies that can be reported to and implemented throughout other nursing homes and long-term care facilities.

Detailed description: In order to achieve these goals the study is being performed at four different nursing homes and will include patients with active or with recent COVID-19 infection, as well as nursing home staff members. The study will test a multimodal aging-friendly intervention including four components and hypothesizes that the implementation of this organizational, educational, quality improvement program will be associated with lower odds of SARS-CoV-2 transmission to the environment.

Eligibility criteria: Inclusion criteria for nursing home patients:

* 18 years of age or older
* Residing in a participating nursing home facility
* Active or recent (last 14 days) COVID-19 infection

Exclusion criteria for nursing home patients:

* Not located in a participating nursing home facility

Inclusion criteria for healthcare workers:

- Healthcare worker at a participating nursing home facility

Exclusion criteria for healthcare workers:

- None

Primary outcomes:
measure: Surface contamination with SARS-CoV-2
timeFrame: 3 months, depending on COVID-19 epidemiology
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06304649: Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures
Official title: Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fractures, Closed
Fractures Bone
Fracture
Fractures
Radius; Fracture, Lower or Distal End
Ulna Fractures
Radius Distal Fracture
Lead sponsor: Cast21
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.

A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.


Eligibility criteria: Inclusion Criteria:

* Demographic characteristics: all persons ages 3 and above, regardless of the race and sex will be eligible to participate in this study
* Medical condition: participants must present with a closed, nondisplaced, or minimally displaced distal radius fracture and/or distal ulnar fracture that does not require a bone reduction procedure within 10 days from the date of injury
* Sizing: participants eligible for the Cast21 Short Arm Product must undergo sizing conducted by the clinical staff to ensure fit into one of the products (sizes XS-L)

Exclusion Criteria:

* Participants requiring a surgical intervention
* Participants with moderately displaced or angulated fractures or fractures requiring a bone reduction procedure.
* Participants with a known history of bone diseases e.g. osteogenesis imperfecta or other pathologic bone conditions
* Participants with pathologic fractures e.g., presence of bone cyst
* Participants who smoke
* Participants with pre-existing skin infection or condition of the lower arm (participants exhibiting only minor skin abrasions, lacerations, or skin condition might be eligible per clinical investigator's discretion)

Primary outcomes:
measure: Clinical determination of healing (standard of care)
timeFrame: At treatment completion, an average of 4 weeks
measure: Range of Motion (standard of care)
timeFrame: At treatment completion, an average of 4 weeks
Secondary outcomes:
measure: Patient Reported Outcomes - Pain
timeFrame: Before treatment (0 Days) and at treatment completion, an average of 4 weeks
measure: Patient Reported Outcomes - Satisfaction
timeFrame: At treatment completion, an average of 4 weeks
measure: Physical Therapy Referral
timeFrame: At treatment completion, an average of 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06148649: Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
Official title: A Phase 2, Multicenter, Randomised, Paralleled, Placebo-controlled (Double-blind) and Active Drug-controlled (Open) Study to Investigate Efficacy and Safety of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 234
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: This is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with T2DM.

Patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. Approximately 225 participants will be randomized. The study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).


Eligibility criteria: Inclusion Criteria:

1. Male or female patients 18 to 75 years of age, inclusive.
2. Have T2DM for at least 3 months before screening based on the disease diagnostic criteria (WHO 1999).
3. Have an HbA1c value of ≥7.5% and ≤10.5%, fasting blood-glucose ≤13.9 mmoL/L, at screening and visit 3.

Exclusion Criteria:

1. Have type 1 diabetes mellitus.
2. Have had ≥1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months).
3. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range at screening.
4. Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) at screening.
5. Have serum calcitonin ≥20 ng/L at screening.
6. Fasted triglycerides \> 5.7 mmol/L at screening.

Primary outcomes:
measure: Change from baseline of HbA1c at week 12
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Change from baseline of weight at week 12
timeFrame: Baseline to week 12
measure: Change from baseline of fasting blood-glucose at week 12
timeFrame: Baseline to week 12
measure: Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to week 15
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: Shijiazhuang People's Hospital
state: Hebei
Study officials:
References:
Clinical trial NCT02452606: Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease
Official title: Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Sleep Disorders
Keywords: Stalevo
sleep disturbance
central circadian clock
narcolepsy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the genetic variants of clock and narcolepsy genes that determine the therapeutic effects of Stalevo® on the quality of sleep in patients with Parkinson's Disease.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with PD in accordance with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (Hughes AJ, et al. 1992).
2. Patients with PD who have wearing off phenomenon.
3. Patients with PD with Hoehn and Yahr stage 1-4.
4. Patients with PD who have sleep problems (PDSS score ≤120 or Epworth Sleepiness Scale(ESS) score ≥ 8).
5. Patients with PD who showed Montreal Cognitive Assessment (MoCA) score ≥15.
6. Patients with PD who have no major depression (Geriatric depression scale, GDS ≤ 24)

Exclusion Criteria:

1. Secondary parkinsonism
2. Parkinson-plus syndromes (multiple system atrophy, progressive supranuclear palsy, and corticobasal degeneration.
3. Patients with PD who have history of severe side effect of Stalevo®.

Primary outcomes:
measure: The correlation of the genetic variants of central circadian clock and narcolepsy genes with regard to the treatment effect of Stalevo® in sleep disturbance of parkinson's disease.
timeFrame: 2 years
Secondary outcomes:
measure: The effectiveness of Stalevo® in bedtime on the quality of sleep in PD patients with motor fluctuation (using Parkinson's Disease Sleep Scale)
timeFrame: up to 3 months from enrollment.
measure: The effectiveness about improving the EDS(Excessive daytime sleepiness) in PD patients with motor fluctuation after taking Stalevo® in bedtime.
timeFrame: up to 3 months from enrollment.
measure: The effectiveness about improving the morning motor symptoms in PD patients with motor fluctuation after taking Stalevo® in bedtime.
timeFrame: up to 3 months from enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sun Ju Chung, Professor
role: PRINCIPAL_INVESTIGATOR
References: