louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06387979: Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies
Official title: Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Glioma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-04-29
Enrollment: 285
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: Patients suspected to have glioma tumors scheduled to undergo tumor resection.

Brief summary: This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery.

Detailed description: PRIMARY OBJECTIVES:

I. To explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to:

Ia. Identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; Ib. Identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and therefore differentiate between IDH-mutant and wild-type gliomas.

OUTLINE: This is an observational study.

Patients undergo tissue sample collection and DESI-MS during standard of care surgery and have their medical records reviewed on study. Patients also undergo MRI per standard of care on study.

Eligibility criteria: Inclusion Criteria:

* Male and female patients age 18 and older
* Patients or their legally authorized representative (LAR) able to provide written consent
* Schedule to undergo tumor resection

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Pathological state of the tissue
timeFrame: Up to 5 years
measure: Percentage of tumor infiltration
timeFrame: Up to 5 years
measure: Presence of IDH mutations
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Alfredo Quinones-Hinojosa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06417879: Attitude And Practice of Egyptian Dental Practitioners Regarding Restoration Repair
Official title: Attitude And Practice of Egyptian Dental Practitioners Regarding Restoration Repair: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Practice
Attitude
Dental Restoration Repair
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 316
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian dental practitioners that have completed their bachelor's degree, internship, have practice license and registered in the Egyptian Dental Syndicate.

Brief summary: This is a cross-sectional study with an aim to evaluate the variations in self-reporting attitude and practice of restoration repair among Egyptian dental practitioners utilizing a survey questionnaire.

It is undeniable that "Minimally invasive dentistry" nowadays offers solutions to prolong the longevity of resin composite restoration with adhesive technology. Due to the limited lifespan of dental restorations, defects are more prone to occur in the existing restorations and thus require dental treatment. it was stated in the literature that repairing could offer better advantages even though replacement of a restoration is a more common choice by many clinicians.

Since the concept of preserving tooth structure nowadays plays a major part in dental practice, invistigators need to understand where Egyptian dental practitioners stand in understanding and applying the concept of restoration repair. Assessment of knowledge and the missing data regarding the concept of repair that dentists in Egypt have could help understand their awareness in applying conservatism in daily practice. There were some research about knowledge, attitude and practice of restoration repair in of dental practitioners in other countries, but little was known in Egypt.


Eligibility criteria: Inclusion Criteria:

* Egyptian dental practitioners that have completed their bachelor's degree, internship, have practice license and registered in the Egyptian Dental Syndicate.

Exclusion Criteria:

* Undergraduate dental students
* Dental practitioners that are still in internship
* Dental practitioners that don't have their practice license yet.
* Dental practitioners that are not registered in the Egyptian Dental Syndicate.

Primary outcomes:
measure: Practice of Egyptian dental practitioners toward repair restoration
timeFrame: After data collection (4 months)
measure: Attitude of Egyptian dental practitioners toward repair restoration
timeFrame: After data collection (4 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04326179: Targeting Infant Development With Early Screening
Official title: Targeting Infant Development With Early Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Development, Child
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 7720
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Duke Children's Primary Care Roxboro Road

Brief summary: The purpose of this study is to assess feasibility and acceptability of parent-completed screeners of child social/emotional development, social determinants of health, and adverse childhood experiences in the setting of a pediatrics primary care clinic.

Detailed description: Local pediatric primary care practices are beginning to implement universal screening. The investigators plan to assess feasibility and acceptability of screening by querying parents of children in order to determine their expectations, perceptions, and opinions about the screeners. The investigators will also use data from electronic health records to examine the impact of screeners on referrals and healthcare utilization. The investigators will be examining screening rates and outcomes, and correlations with demographics and changes over time.

Eligibility criteria: Inclusion for general practice retrospective reviews:

* Seen for a well child check at Duke Children's Primary Care Roxboro Road.
* Age 0 to 4 at day of visit

Inclusion for targeted retro reviews:

* Seen for well check at Duke Children's Primary Care Roxboro Road
* Determined by HealthySteps to require Tier 2 or Tier 3 behavioral support services
* Age 0 to 4 at day of visit

Primary outcomes:
measure: Screening results
timeFrame: 18 months
Secondary outcomes:
measure: Screening compliance
timeFrame: 18 months
measure: Rate of attending scheduled appointments (show rate)
timeFrame: 18 months
measure: Healthcare utilization
timeFrame: 18 months
measure: Referral rates
timeFrame: 18 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Debra Best, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03855579: Levosimendan Versus Milrinone in Off Pump CABG Surgery
Official title: Levosimendan Versus Milrinone to Support Hemodynamics During Off Pump Coronary Artery Bypass Grafting Surgery in Patients With Poor Ejection Fraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemodynamics
Keywords: Levosimendan
Milrinone
Off-pump
Coronary
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.

Detailed description: The major challenge during off-pump coronary artery bypass graft surgery is to maintain optimum hemodynamics by optimizing the intravascular volume and by using some inotropes. However, conventional inotropes such as beta-agonists are associated with tachycardia and arrhythmia which increase myocardial oxygen demand.

Levosimendan is an inodilator which exerts its positive inotropic effect by enhancing the sensitivity of troponin C to calcium without increasing intracellular calcium concentration. Levosimendan also decreases the systemic vascular resistance, so, it increases the cardiac output without increasing myocardial oxygen consumption.

This study aims to compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.

Eligibility criteria: Inclusion Criteria:

* Elective off-pump coronary artery bypass grafting surgery.
* ejection fraction \< 50%

Exclusion Criteria:

* Patients with severe renal impairment or renal failure.
* Patients on mechanical support (intra-aortic balloon pump)

Primary outcomes:
measure: Mean blood pressure
timeFrame: Intraoperative
measure: Consumption of other inotropes
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT02256579: Utility of Urinary beta2 Microglobulin as an Early Marker of Renal Dysfunction in Vietnamese HIV-Infected Patients
Official title: Vietnam-Japan Cooperative Research on Prognosis of HIV-1-infection -Clinical Utility of Urinary beta2 Microglobulin as an Early Marker of Renal Dysfunction Caused by Use of Tenofovir in Vietnamese HIV-Infected Patients-
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infection
Renal Function Disorder
Renal Tubular Disorder
Keywords: TDF:Tenofovir, Urine beta2microglobulin
Lead sponsor: National Center for Global Health and Medicine, Japan
Sponsor class: OTHER_GOV
First posted: 2014-10-03
Enrollment: 1800
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vietnamese HIV-infected patients who are registered in the NHTD (National Hospital of Tropical Diseases) -ACC (AIDS Clinical Center, NCGM) cohort.

Brief summary: This study is to investigate clinical utility of beta2 microglobulin as an early marker for renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.

Detailed description: An observational study to investigate clinical utility of beta2 microglobulin as an early marker for renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.

Eligibility criteria: Inclusion Criteria:

* HIV-infected patients in the NHTD -ACC cohort who are under cART or will start cART and can provide written informed consents.

Exclusion Criteria:

* HIV-infected patients who drop out of treatment within 6 months from the entry.

Primary outcomes:
measure: Evaluation of urinary beta2microglobulin, urinary protein and serum creatinine among Vietnamese HIV-infected patients
timeFrame: 3 years
Secondary outcomes:
measure: Evaluation of risk factors for renal dysfunction and tubular dysfunction
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: National Center for Global Health and Medicine
name: Shinichi Oka, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01314079: Follow-up Study of Autologous Cultured Adipose-derived Stem Cells for the Crohn's Fistula
Official title: Follow-up Study to Evaluate the Sustained Efficacy and Safety for the Patients With Adipoplus Injected in Phase II Clinical Trials(ANTG-ASC-202)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Fistula
Keywords: Crohn's fistula
Autologous adipose derived stem cell
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who have participated in phase II clinical trial (ANTG-ASC-202) and injected with Adipoplus at least once.

Brief summary: This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial.


Eligibility criteria: Inclusion Criteria:

* the patients who have participated in ANTG-ASC-202 clinical trial
* the patients who have experienced with Adipoplus in ANTG-ASC-202 trials
* the patients who submit written consents and is able to obey requirements of trials

Exclusion Criteria:

* pregnant or breast feeding
* autoimmune disease other than Crohn's disease
* infectious diseases including HBV, HCV or HIV
* who is not willing to use effective contraceptive methods during the study.
* active tuberculosis
* moderate to severe active or worsened Crohn's disease
* who have received Infliximab during or after ANTG-ASC-202 trial

Primary outcomes:
measure: Number of patients with Sustained efficacy of complete closure of fistula
timeFrame: Month 4, 10
Secondary outcomes:
measure: Number of patients with sustained efficacy of closure of fistula
timeFrame: Month 2, 4, 10
measure: Number of patients with any adverse event
timeFrame: Month 2, 4, 10
measure: Grade of Investigator's satisfaction
timeFrame: Month 2, 4, 10
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: DaeHang Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Hospital
Study officials:
affiliation: Asan Medical Center
name: CS You, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00366379: A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.
Official title: An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus treated with one oral antihyperglycemic agent for \>=3 months prior to screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
* women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Primary outcomes:
measure: Percentage of patients at each dose who achieve FPG <100mg/dL.
timeFrame: Throughout study
Secondary outcomes:
measure: Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.
timeFrame: At intervals throughout study
measure: AEs, laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Oviedo
country: United States
state: Florida
city: Nampa
country: United States
state: Idaho
city: Evansville
country: United States
state: Indiana
city: Butte
country: United States
state: Montana
city: Canton
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Greer
country: United States
state: South Carolina
city: Midland
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Tartu
country: Estonia
city: Tartu
country: Estonia
city: Jelgava
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Chihuahua
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Pachuca
country: Mexico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01382979: Evaluation of AlcoholEdu for College
Official title: Evaluation of AlcoholEdu: A Randomized Multi-Campus Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Misuse
Keywords: Alcohol misuse prevention
College students
Intervention and control
Lead sponsor: Pacific Institute for Research and Evaluation
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 9571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study examined whether an online course for college freshmen (AlcoholEdu) had an effect on alcohol misuse and related problems, using a randomized controlled design with 30 universities.


Eligibility criteria: Inclusion Criteria:

* Colleges without an online alcohol prevention course
* Able to implement AlcoholEdu course for all incoming freshmen
* Able to provide random student samples for data collection
* Able to obtain IRB approval for study

Exclusion Criteria:

* Already implementing alcohol prevention course for incoming freshmen
* Not able to implement online alcohol prevention course
* Not able to provide random student samples for data collection
* Not able to obtain IRB approval for study

Primary outcomes:
measure: Binge drinking
timeFrame: 30 days
Secondary outcomes:
measure: Alcohol-related problems
timeFrame: 30 days
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Prevention Research Center
state: California
Study officials:
affiliation: Pacific Institute for Research and Evaluation
name: Mallie J. Paschall, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paschall MJ, Antin T, Ringwalt CL, Saltz RF. Evaluation of an Internet-based alcohol misuse prevention course for college freshmen: findings of a randomized multi-campus trial. Am J Prev Med. 2011 Sep;41(3):300-8. doi: 10.1016/j.amepre.2011.03.021.
Clinical trial NCT06611579: Clinical Study of the inQB8 TTVR System
Official title: A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Valve Regurgitation
Lead sponsor: inQB8 Medical Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2024-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.

Detailed description: The study is a multi-center, prospective, single-arm study to assess safety and performance of the inQB8 Medical Technologies MonarQ Tricuspid Valve Replacement System.

Eligibility criteria: Inclusion Criteria:

* Anatomically suitable for the MonarQ TTVR System
* Symptomatic, tricuspid regurgitation (TR) that is severe or greater
* Adequately treated for heart failure based upon medical standards
* Hemodynamically stable

Exclusion Criteria:

* Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days
* Refractory Heart Failure (HF) that requires or required advanced intervention
* Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-up.
* Currently participating in another investigational biologic, drug or device study

Primary outcomes:
measure: Absence of device or procedure related major adverse events
timeFrame: 30 days
measure: Change in TR grade from baseline
timeFrame: 30 days
Secondary outcomes:
measure: Device and procedure related complications
timeFrame: 30 days and 12 months
measure: NYHA functional classification
timeFrame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
measure: Six-minute-walk test
timeFrame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
measure: Health status - KCCQ
timeFrame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
measure: TR grade
timeFrame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
measure: Hospitalization
timeFrame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hosptial and Medical Center
state: California
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Plano
country: United States
facility: Baylor Heart Hospital
state: Texas
Study officials:
References: