louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02949310: Effectiveness of Nefopam in Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasm Malignant Primary
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 88
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer surgery is known to cause severe acute postoperative pain, which can persist for a long time. The investigators administered nefopam preventively to patients undergoing total mastectomy or modified radical mastectomy with axillary lymph node dissection or sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative pain.


Eligibility criteria: Inclusion Criteria:

* Total mastectomy
* Modified radical mastectomy
* Nipple-sparing mastectomy
* American Society of Anesthesiologists physical status I or II
* Postoperative use of intravenous patient-controlled analgesia

Exclusion Criteria:

* Chronic analgesia medication
* Pregnancy
* Lactating women
* Previous operation history due to breast cancer
* Cooperation with other surgery
* Contraindication of nefopam

Primary outcomes:
measure: Change of cumulative analgesia volume infused via intravenous patient-controlled analgesia device
timeFrame: At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month
Secondary outcomes:
measure: Change of numerical rating scale for postoperative pain
timeFrame: At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT05680610: Follow up of Moderate Aortic Regurge After Mitral Valve Replacement
Official title: Follow up of Moderate Aortic Regurge After Rhumatic Mitral Valve Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Follow up of Moderate Aortic Regurge After Rheumatic Mitral Valve Replacement
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who underwent mitral valve replacement with untrated concomitant moderate aortic regurge in Asyut university hospitals

Brief summary: Aim of the study is to follow of of moderate aortic regurge after mitral valve replacement to figure out if the aortic regurge has been improved or it is getting worse

Detailed description: A considerable proportion of patients who require mitral valve replacement present with a coexisting pathology of the aortic valve (AV). Rheumatic fever remains the leading cause for combined disease (1) Early series found that one-third of rheumatic hearts exhibited involvement of both mitral and aortic valve. The rate increased to 99% when the follow-up period was extended to 20 years The treatment of choice in cases in which one of the valves is moderately affected is questionable. Because combined aortic and mitral valve replacement is usually associated with higher risk and poorer long-term survival than replacement of either of the two valves alone (2) In patients with moderate aortic regurgitation who undergo mitral valve surgery). according to 2021 ESC/EACTS Guidelines, the decision to treat the aortic valve is controversial, as data show that progression of moderate aortic regurgitation is very slow in patients without aortic dilation (3) in contrast , In 2020 AHA guidelines recommended concomitant aortic valve replacement for moderate aortic regurgitation in patients undergoing surgery for ascending aorta, coronary artery bypass grafting (CABG),or mitral valve surgery (4-10) Because of this is a point of conflict we aim in this study to evaluate the saftey to leave moderate aortic regurge without intertvention as regarding operative time ,postoperative morbidity and mortality and progression of aortic valve regurge.

Eligibility criteria: Inclusion Criteria:

* patients underwent mitral valve replacement for rheumatic heart disease and having moderate aortic valve regurge GRADE 2 in assuit university hospitals

Exclusion Criteria:

* non rhumatic heart disease ,severe aortic regurge ,moderately severe aortic regurge ,combined ischmic and valvular heart diseaese

Primary outcomes:
measure: Comparison between pre operative degree of aortic regurge and Postoperative degree of aortic regurge after rheumatic mitral valve replacement
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine
state: Assuit
Study officials:
References:
Clinical trial NCT01407510: HPA Axis Study in Japanese Adults
Official title: A Multicenter, Open-label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Japanese Adults With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Eczema
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-02
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.

Detailed description: Assessment of the adrenal suppression potential, safety, efficacy and pharmacokinetics of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Male or female subject aged \>= 20 years
* Diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria
* Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline
* Normal ACTH response before start of treatment

Exclusion Criteria:

* Pregnancy or lactation
* Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
* Concomitant medical or dermatological disorder(s), which could interfere with the investigator's ability to evaluate the subject's response to the investigational product
* Clinically manifest immunosuppressive disorder or known history of malignant disease

Primary outcomes:
measure: number of subjects with adrenal suppression
Secondary outcomes:
Other outcomes:
Locations:
city: Saitama
country: Japan
facility: Kawaguchi Kogyo General Hospital
city: Tokyo
country: Japan
facility: Clinical Research Hospital Tokyo
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01538810: Biomarker Correlates of Radiologic Imaging
Official title: Biomarker Correlates of Radiologic Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal CT Imaging Performed as Standard of Care
Keywords: CT imaging
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 751
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone undergoing an abdominal image, meeting eligibility criteria.

Brief summary: The purpose of this study is to assemble a collection of urine and blood samples for the development and validation of biomarkers potentially useful in correlating or improving the diagnostic utility of abdominal imaging.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Undergoing abdominal CT imaging (standard of care)
* Signed, informed consent

Exclusion Criteria:

* Patients on dialysis

Primary outcomes:
measure: Quantitative measures
timeFrame: at enrollment
Secondary outcomes:
measure: differentiation of cancerous from non-cancerous renal mass
timeFrame: at analysis
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jerry Morrissey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03076710: Post-Operative Pain Management Following Spine Surgery
Official title: Two-Stage, Pilot, Prospective, Observational Study of Post-Operative Pain Management Following Spine Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pain Management
Analgesia
Anesthetic
Keywords: spine surgery
post-operative pain
patient controlled analgesia
Exparel®
bupivacaine
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2017-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary, single level, lumbar fusion surgical procedures.

Brief summary: The primary objective of this pilot study is to assess the feasibility of comparing two standardized approaches to manage post-operative pain following spine surgery: one approach using Patient Controlled Analgesia (PCA) devices to deliver opioid analgesics, and the other approach using EXPAREL® infiltration at the site of surgery and nurse-administered opioid analgesics.

Detailed description: The study will assess the feasibility of the methods proposed, including recruitment, eligibility, standardization of both post-operative pain management approaches, and assessment of clinical, hospital efficiency, medication use, health services use, and economic outcomes.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Ability to speak, read, and write in English or Spanish
* Primary indication is low back pain, radiculopathy, disc degeneration, disc herniation, foraminal stenosis, or mild 1-level spondylolisthesis or deformity
* Scheduled to undergo primary, single level, lumbar fusion surgical procedure at the study center in the next 30 days
* Willing to provide informed consent, participate in study, and comply with study protocol

Exclusion Criteria:

* Body mass index \>35
* Pregnant or contemplating pregnancy prior to surgery
* Current or previous psychiatric, behavioral, or emotional disorder that may interfere with postsurgical pain, analgesia, or opioid use according to treating surgeon
* Prior treatment for alcohol, recreational drug, or opioid abuse
* Chronic inflammatory conditions (e.g. Crohn's, lupus, rheumatoid arthritis)
* Chronic neurologic conditions (e.g. multiple sclerosis, Parkinson's)
* Serious spinal conditions (e.g. cauda equina syndrome, infection, tumor, fracture)
* Hypersensitivity or allergy to local anesthetics
* Previous surgery in lumbar spine (i.e. other than microdiscectomy);
* Continuous (e.g. daily) opioid consumption for more than 30 days prior to surgery

Primary outcomes:
measure: Pain severity at the site of surgery
timeFrame: 4 hours post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Steven Vanni, DO, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02281110: The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses
Official title: A Prospective, Observational, Non-randomized European, Multi-center Registry Collecting Real Life Information for the Utilization of Instantaneous Wave Free Ratio in Assessing Coronary Stenosis Relevance in the Multi-vessel Disease Patients Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: Diagnostic coronary catheterization
Multi-vessel coronary disease
Percutaneous Coronary Intervention
Instantaneous wave free ratio
Fractional flow reserve
Lead sponsor: Volcano Corporation
Sponsor class: INDUSTRY
First posted: 2014-11-02
Enrollment: 500
Sex: ALL
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: Eligibility includes adults undergoing coronary angiography and/or PCI

Brief summary: The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac catheterization.

Detailed description: The REAL Registry will enroll a maximum of 3,000 patients in approximately 300 sites across multiple European and Middle East countries, where product has received CE approval and is marketed. An average of 10 cases with a maximum of 50 patients will be enrolled per participating site.

No follow-up will be performed. The REAL Registry will only collect data during diagnostic angiogram or PCI procedure, when performed.

Eligibility criteria: Inclusion Criteria:

* Over 18 year of age
* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
* Eligible for coronary angiography and PCI
* Coronary artery disease with at least two or more visually assessed coronary stenoses (greater than 40% diameter stenosis) in native, major epicardial vessel or its branches by coronary angiogram with an indication of physiological assessment.

Exclusion Criteria:

* Inability to obtain a signed informed consent from potential patient.
* Any contraindication for functional assessment as per the instructions per use and determined by the investigator.

Primary outcomes:
measure: Hemodynamic severity (Percentage of stenosis properly classified by iFR®)
timeFrame: Day 1 (Post-Procedure)
Secondary outcomes:
measure: changes in iFR® and FFR
timeFrame: Day 1 (Post-Procedure)
measure: Changes to decision strategy of revascularization
timeFrame: Day 1 (Post-Procedure)
Other outcomes:
Locations:
city: Zaventem
country: Belgium
facility: Volcano Europe BVBA/SPRL
Study officials:
References:
Clinical trial NCT04703010: Neonatal Precursors of Neurodevelopment
Official title: Neonatal Precursors of Neurodevelopment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Birth
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 90
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal study with measures at birth and at age 2.
Primary purpose: BASIC_SCIENCE

Brief summary: The NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive precursors and neurodevelopment.


Eligibility criteria: Inclusion Criteria:

* Preterm newborn (born \< 34 weeks + 6days)

Exclusion Criteria:

* Brain injury
* Respiratory assistance on measurement day
* Infection on measurement day
* Sedation on measurement day
* Parents \< 18 years old or unable to give informed consent

Primary outcomes:
measure: Electroencephalography evoked response amplitude
timeFrame: 35 weeks of gestational age
measure: Near infrared spectroscopy evoked response amplitude
timeFrame: 35 weeks of gestational age
measure: Grey matter volume in the somatosensory cortex
timeFrame: 35 weeks GA
measure: Frontal-parietal structural connectivity
timeFrame: 35 weeks GA
measure: Frontal-parietal functional connectivity
timeFrame: 35 weeks GA
measure: Quality of cognitive development
timeFrame: 2 years old
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT06130410: Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years
Official title: COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) Special Investigation for Booster Immunization in Children Aged 6 Months to 4 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
COVID-19
Keywords: COVID-19
SARS-CoV-2
Children (6 months though 4 years old)
RNA Vaccine
Post-Marketing Study
Pediatric
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-11-14
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children of 6 months though 4years of age, at the time of booster vaccination(4th dose)

Brief summary: The purpose of this post-marketing study is to assess the safety of Comirnaty monovalent XBB.1.5. for booster vaccination children ages 6 months though 4 years under actual use medical practice.


Eligibility criteria: Inclusion Criteria:

* Children aged 6 months to 4 years at the time of the booster vaccination (4th dose) who (or whose representative) gave written consent to take part in the study.

Exclusion Criteria:

-There are no exclusion criteria for this study.

Primary outcomes:
measure: Percentage of participants with adverse reaction
timeFrame: For 28 days after the booster dose
measure: Percentage of participants with serious adverse reaction
timeFrame: For 28 days after the booster dose
measure: Percentage of participants with reactogenicity events.
timeFrame: For 7 days following the booster dose
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Local Country
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02638610: Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries
Official title: Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blepharoptosis
Blepharochalasis, Superior
Ectropion
Entropion
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study: Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries.

Study design: an interventional study that will be conducted at the ophthalmology department, Meir hospital, Kfar Saba, Israel.

the study will include 60 healthy patients, at the ages of 40-80, which are candidates for eyelid surgery: blepharoptosis repair, blepharoplasty, ectropion repair and entropion repair.

The patients will be recruited from Meir's ophthalmology outpatient clinic. Each patient will undergo a full ophthalmologic examination including relevant assessment of the specific eyelid pathology.

The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet filament-type aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take place before surgery, and two weeks, three months and six months after surgery.


Eligibility criteria: Inclusion Criteria:

* Ability to give consent
* Eyelid pathology: blepharoptosis, blepharochalasis, ectropion or entropion, with no additional eyelid pathology

Exclusion Criteria:

* Children and pregnant women
* Previous eyelid surgery
* A systemic disease influencing eyelid position
* Any neurologic disease
* Previous facial herpetic infection

Primary outcomes:
measure: Changes of periocular skin sensation following eyelid and ocular surface surgeries (expressed in the length of the aesthesiometer's filament in centimeters).
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01797510: Feasibility Study for a Web Based Health Coaching Program
Official title: Mayo-Sessions Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 80
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 study is designed to compare an intensive lifestyle and activity coaching program (\&quot;Sessions\&quot;) to usual care for diabetic patients who are sedentary. The question to be answered is whether the Sessions program improves clinical or patient centric outcomes.

Recruitment is through invitiation only.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients age 18 or greater

Exclusion Criteria:

* Patients aged 17 or less,
* Patients with cognition impaired such that they could not comprehend enrollment materials.

Primary outcomes:
measure: Biometrics
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Marc Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00605410: Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness
Official title: Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Methacholine bronchoprovocation
Antimuscarinic
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Royal University Hospital Foundation
First posted: 2008-01-31
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Certain lung disease medications can influence diagnostic tests and research investigations. This study will investigate how long ipratropium bromide must be withheld before a methacholine challenge test can be conducted. This information will be useful for validating current guidelines.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma; stable and controlled
* FEV1 greater than or equal to 65% predicted

Exclusion Criteria:

* Concomitant lung disease other than asthma

Primary outcomes:
measure: methacholine PC20
timeFrame: 6hours and 12 hours post inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: Department of Medicine University of Saskatchewan
name: Donald W Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Illamperuma C, Davis BE, Fenton ME, Cockcroft DW. Duration of bronchoprotection of inhaled ipratropium against inhaled methacholine. Ann Allergy Asthma Immunol. 2009 May;102(5):438-9. doi: 10.1016/S1081-1206(10)60519-4. No abstract available.