louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01462084: Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
Official title: Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Central Sleep Apnea (Diagnosis)
Chronic Opioid Use
Keywords: sleeping
opioid medications
positive airway pressure
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA) complicated by central sleep apnea (CSA) due to the chronic use of opioid medications

Detailed description: The trial seeks to determine the efficacy and patient comfort of ASV and bi-level positive airway pressure (PAP) modes for the treatment of obstructive sleep apnea (OSA), complicated by CSA secondary to opioid use. Subjects will be randomized to one of two groups, utilizing a cross-over design to evaluate the two modes with the subject as their own control.

Subjects will be asked to undergo two PSG studies; one with ASV titration and one with bi-level treatment, using the current pressure prescription. The study comprises two visits. Subjects will be asked to complete patient satisfaction questionnaires following their PSG studies. It is anticipated that total subject participation will be no longer than one month.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Taking opioid medications for at least 6 months. Opioid medications include but are not limited to: oxycodone, fentanyl, methadone, levorphanol, hydromorphone, and morphine
* Using bi-level PAP for at least 30 days

Exclusion Criteria:

* Primary heart or lung disease, for example: chronic obstructive pulmonary disease, pulmonary fibrosis, severe heart failure, uncorrected congenital heart disease, pulmonary hypertension
* Primary neurologic disease, for example: neuromuscular disease, previous stroke or cognitive impairment
* Narcolepsy
* Acute upper respiratory tract infection
* Pregnant

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: Up to 1 month
Secondary outcomes:
measure: Patient Comfort
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Center for Human Sleep Research
state: California
Study officials:
affiliation: Stanford Center for Human Sleep Research
name: Michelle Cao, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03181984: Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
Official title: Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Port-Wine Stain
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-09
Enrollment: 501
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to provide safety information of hemoporfin during the post-marketing period as required by China Food and Drug Administration (CFDA) regulations in order to identify any potential drug related treatment factors in the Chinese population, such as unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine drug uses.


Eligibility criteria: Inclusion Criteria:

* Age range: 14 to 65 years-old；
* Clinically diagnosed of Port-wine Stain;
* Patients receiving hemoporfin based upon the clinical judgment of the investigator;
* Written informed consent signed and agreed to receive periodic follow-up

Exclusion Criteria:

* Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
* Scar diathesis;
* Pregnancy or unwilling to adopt reliable contraceptive measures during the month after drug application;
* Be judged not suitable to participate the study by the investigators

Primary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 96 weeks after hemoporfin application
Secondary outcomes:
measure: Satisfaction rating of the overall treatment by subjects
timeFrame: 8, 24 and 96 weeks after hemoporfin application
measure: Satisfaction rating of the overall treatment by investigators
timeFrame: 8 weeks after hemoporfin application
measure: Response rate
timeFrame: 8 weeks after hemoporfin application
Other outcomes:
Locations:
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Shijiazhuang
country: China
facility: Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine
state: Herbei
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: PLA Army General Hospital
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
Study officials:
affiliation: Peking University First Hospital
name: Xuejun Zhu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
name: Jining Tao
role: STUDY_DIRECTOR
References:
Clinical trial NCT03447379: Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent
Official title: Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 1452
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®)


Eligibility criteria: Inclusion Criteria:

1. Age 19+
2. Patients treated with a new generation of Evelorimus-eluting stents (Synergy®)
3. Patients who understand the content of the subject description and voluntarily sign the subject

Exclusion Criteria:

1. Age 86+
2. Hemodynamically unstable patient
3. Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent
4. Patients at high risk of bleeding, anemia, thrombocytopenia
5. Patients requiring oral anticoagulants
6. Pregnant women or women of childbearing age
7. Life expectancy is less than one year
8. Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir)
9. Patients with a history of intracranial hemorrhage
10. Patients with moderate to severe hepatic impairment
11. Patients underwent coronary intervention with stenting within 1 year
12. Patients with left-main lesions requiring coronary intervention
13. Patients with chronic stricture lesions requiring treatment
14. Patients with in-stent restenosis in a lesion requiring treatment
15. Patients with bifurcation lesions requiring stenting in lateral branches
16. Patients with lesions requiring more than 3 stents

Primary outcomes:
measure: Major adverse cardiovascular clinical events (MACCE)
timeFrame: between 3 and 12 month after the procedure
measure: Major bleeding
timeFrame: between 3 and 12 month after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
state: Souel
Study officials:
affiliation: Gangnam Severance Hospital
name: Bumkee Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03897179: INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study
Official title: INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement.
* Passed health assessment screening
* Negative pregnancy test for female subjects of child bearing potential.

Exclusion Criteria:

* Physical status of ASA III, IV, or V
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Positive pregnancy test for female subjects
* Refusal to take pregnancy test for women of child bearing potential
* Nursing female subjects
* Subjects wearing acrylic nails or subjects refusing to remove nail polish
* Subjects who have a nail deformity on the measurement finger
* Subjects who do not have adequate skin integrity on the measurement finger
* Excluded at the Principal Investigator's discretion

Primary outcomes:
measure: RRp Arms of Sensor Accuracy
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References:
Clinical trial NCT01323179: Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)
Official title: Acute Pain After Fast-track Total Knee Arthroplasty: Preoperative Opioid Versus Non-opioid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Postoperative pain
Postoperative opioid requirements
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients operated with elective, primary, unilateral total knee artroplasty (TKA).

Brief summary: Observational study evaluating pain response after total knee arthroplasty (TKA) in patients taking strong, weak or no opioids preoperatively.


Eligibility criteria: Inclusion Criteria:

Patients operated with elective, primary, unilateral total knee arthroplasty (TKA) (taking strong or weak opioid daily for minimum 4 weeks or opioid naive patients)

Exclusion Criteria:

* Bilateral / revision arthroplasty
* Disease affection central or peripheral nerve function
* Alcohol and medical abuse
* Daily use of glucocorticoids
* Malignancy
* BMI \> 40
* Dementia or other cognitive dysfunction
* Treatment of anxiety or depression

Primary outcomes:
measure: Pain
timeFrame: 24 hours
Secondary outcomes:
measure: Pain
timeFrame: 7 days
measure: Opioid consumption
timeFrame: 7 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of Anesthesiology, Hvidovre University Hospital
state: Hvidovre
city: Hellerup
country: Denmark
facility: Dep. of ortopedic surgery, Gentofte Hospital
city: Holstebro
country: Denmark
facility: Dep. of ortopedic surgery, Regionshospitalet Holstebro
city: Vejle
country: Denmark
facility: Dep. of ortopedic surgery, Vejle Sygehus
Study officials:
affiliation: Dep. of Anesthesiology, Hvidovre University Hospital
name: Troels H Lunn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03865979: AI ENRICH - AI Detection of ICH
Official title: Automated Detection, Characterization, Triage, and Recruitment of ICH Subjects Using Artificial Intelligence in the ENRICH Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracerebral Hemorrhage
Keywords: Artificial Intelligence
ICH
Lead sponsor: Viz.ai, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nico Corporation
First posted: 2019-03-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the performance of the Viz RECRUIT software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation.

Detailed description: This study will be a multicenter prospective feasibility trial to evaluate the performance of the Viz RECRUIT software. This study will enroll subjects evaluated at each center for stroke via CT imaging. The Viz RECRUIT software will review the CT and notify a specialist if an ICH is detected. It will also evaluate the ICH parameters per study specific guidelines related to the ENRICH Trial and notify a specialist if their ICH meets the study inclusion or exclusion criteria related to cerebral blood flow volume. If an enrolled subject is ultimately included in the ENRICH trial, they will be identified in a prospective cohort of subjects exposed to Viz (intervention arm) will be evaluated per the secondary endpoints to a cohort of subjects retrospectively from the ENRICH Trial (control arm) which were evaluated and enrolled prior to Viz use.

Eligibility criteria: Inclusion Criteria:

* Subjects with stroke symptoms who undergo CT brain imaging.

Exclusion Criteria:

* Subjects with poor or incomplete CT brain imaging.

Primary outcomes:
measure: Performance
timeFrame: Enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UAMS Medical Center
state: Arkansas
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: SUNY Buffalo
state: New York
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: The Cooper Health System
name: Brian T Jankowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03960879: DNA Methylation for Screening Uterine Cervical Lesions
Official title: DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: DNA Methylation
Uterine Cervical Cancer
High Grade Squamous Intraepithelial Lesions
Low Grade Squamous Intraepithelial Lesions
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Confirmed cervical histology within one month when collecting cervical cytology
* Aged 18 years or older

Brief summary: The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study.

This study will include 300 unselected patients with definite histological results. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed.

The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.


Eligibility criteria: Inclusion Criteria:

* Confirmed cervical histology within one month when collecting cervical cytology
* Aged 18 years or older
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Sensitivity of DNA methylation
timeFrame: 1 year
measure: Specificity of DNA methylation
timeFrame: 1 year
Secondary outcomes:
measure: Positive predictive value of DNA methylation
timeFrame: 1 year
measure: Negative predictive value of DNA methylation
timeFrame: 1 year
measure: Correlation coefficient of DNA methylation with other screening methods
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02348879: A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 403 in Healthy Subject
Official title: A Placebo Controlled, Randomized, Double-blind, Sequential, Rising, Single Dose Study to Examine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous and Subcutaneous AMG 403 in Healthy Young and Older Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 51
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety of AMG 403 in healthy adult subjects. The study consists of a 21 day screening period followed by administration of the investigational product and up to 154 day evaluation period.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women of non-child bearing potential,
* Between the ages of 18 and 55 inclusive,
* Body mass index from 18 to 33 kg/m2,
* Skin type compatible with the study assessments, and without significant skin allergies, pigmentary disorders, tattoos, or any active dermatologic conditions that might interfere with the study conduct.

Exclusion Criteria:

* Prior or current history of peripheral neuropathy, paraesthesias, dysesthesias, herpes zoster, post-herpetic neuralgia,
* Evidence of any current illness such as a common cold, viral syndrome, or flu-like symptoms, any disturbance of the autonomic nervous system,
* History of Raynaud's phenomenon; Know allergy or intolerance to capsaicin or hot peppers.

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: up to 112 days
measure: Incidence of abnormal clinically significant vital signs
timeFrame: up to 112 days
measure: Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
timeFrame: up to 112 days
measure: Incidence of abnormal clinically significant ECG results
timeFrame: up to 112 days
Secondary outcomes:
measure: Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax
timeFrame: up to 112 days
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Gow JM, Tsuji WH, Williams GJ, Mytych D, Sciberras D, Searle SL, Mant T, Gibbs JP. Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects. Arthritis Res Ther. 2015 Oct 8;17:282. doi: 10.1186/s13075-015-0797-9.
Clinical trial NCT01399879: Measuring Skin Electrical Potential With the Kelvin Probe: Minimizing Noise
Official title: Measuring Skin Electrical Potential With the Kelvin Probe: Minimizing Noise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy State
Keywords: Surface potential
Electrical
Motion stabilization
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The Scanning Kelvin Probe measures surface electrical potential without actually touching the skin. This is a pilot study to evaluate methods of minimizing noise during Scanning Kelvin Probe measurements. This project will focus specifically on noise arising from physical movement and environmental electrical field.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years

Exclusion Criteria:

* chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)
* movement disorders/tremors
* extensive scars on the hand
* latex-allergies
* cardiac implantation, metallic joint/bone replacements (defibrillator or pacemaker)

Primary outcomes:
measure: Variability in surface electrical potential measurements
timeFrame: Within 24 hours of testing
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew C Ahn, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05069779: Diazepam and Blood Pressure Regulation
Official title: The Acute Effects of Diazepam on Blood Pressure Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Blood pressure
Benzodiazepine
Autonomic nervous system
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to determine the acute effects of diazepam on beat-to-beat blood pressure variability and baroreflex control.

Detailed description: Benzodiazepines are widely prescribed for a variety of clinical conditions. However, its cardiovascular consequences remain controversial. In this study, the investigators sought to determine the acute effects of a single dose of oral diazepam (10mg) on resting beat-to-beat blood pressure variability and cardiac and sympathetic baroreflex sensitivity in a cohort of young, healthy individuals.

Eligibility criteria: Inclusion Criteria:

* 18 to 40 years of age
* Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease

Exclusion Criteria:

* History of smoking (tobacco or cannabis), defined as any smoking within the past 3 months
* Diagnosed cardiovascular or metabolic disease(s)
* Prescription of chronic medications other than oral contraceptives
* History of hypertension or presence of arrhythmia

Primary outcomes:
measure: Resting beat-to-beat blood pressure variability
timeFrame: Change from baseline at 60 min
measure: Systolic and diastolic blood pressure
timeFrame: Change from baseline at 60 min
Secondary outcomes:
measure: Muscle sympathetic nerve activity
timeFrame: Change from baseline at 60 min
measure: Baroreflex sensitivity
timeFrame: Change from baseline at 60 min
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: University of Brasilia
state: DF
Study officials:
References: