louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00314496: Development of Magnetic Resonance (MR) Simulation for Treatment Planning
Official title: Development of MR Simulation for Treatment Planning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2006-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with conform histological diagnosis of glioblastoma multiforme signed the consent forms and were willing to go for curative radiation treatment with temozolomide

Brief summary: Retrospectively have access to MR images of patients to develop software that:

1. segment images
2. convert MR values to electron density and then
3. entered into a dose calculation system

The project involves software development of data that is already available. No intervention is made at this point.


Eligibility criteria: Inclusion Criteria:

* Subject 18 years of age and older

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Gino Fallone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02300116: Smart Vision Labs Autorefractor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ocular Refraction
Lead sponsor: Smart Vision Labs
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young adults: ages 18-35 year, including male and female

Brief summary: The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor.


Eligibility criteria: Inclusion Criteria:

* healthy young adults
* ages 18-35 year
* male and female

Exclusion Criteria:

* presence of ocular disease
* refractive surgery
* amblyopia

Primary outcomes:
measure: refractive errors
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: SUNY/College of Optometry
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Kenneth Ciuffreda, O.D, PH.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05262816: Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury
Official title: Urodynamic Analysis of the Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurogenic Bladder
Keywords: Electroacupuncture
Neurogenic Bladder
Spinal Cord Injury
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Neurogenic bladder after spinal cord injury can be divided into detrusor hyperreflexia and detrusor non reflexia. Acupuncture is recognized as a safe and effective treatment. The most commonly used acupoints are Guanyuan, Zhongji and Sanyinjiao. The purpose of this study is to clarify the therapeutic effects of different acupoints on different types of bladder. Main process: routine urodynamic examination was performed first, and then electroacupuncture was given to Guanyuan, Zhongji and Sanyinjiao points respectively, and urodynamic examination was performed again to observe the effect of Electroacupuncture on urodynamic parameters in real time.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with traumatic suprasacral SCI.
* the period of the spinal shock has passed.
* patients with voiding dysfunction after SCI.
* patients had stable condition, and suitable for treatment.
* agreed to engage in our study and sign the informed consent.

Exclusion Criteria:

* Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system, endocrine system and psychosis.
* dysuria caused by non spinal cord injury, such as prostatic hypertrophy, urethral obstruction, operation.
* Patients who have already taken cystostomy and sacral electrode implantation.
* Patients with urinary tract infection.
* Autonomic hyperreflexes were obvious.
* Unable to cooperate with the healer.

Primary outcomes:
measure: Perianal surface electromyography
timeFrame: Procedure (While doing acupuncture )
measure: detrusor overactivity (DO)
timeFrame: Procedure (While doing acupuncture )
measure: bladder compliance (BC)
timeFrame: Procedure (While doing acupuncture )
measure: maximum cystometric capacity (MCC)
timeFrame: Procedure (While doing acupuncture )
measure: maximum urinary flow rate (Qmax)
timeFrame: Procedure (While doing acupuncture )
measure: maximum detrusor pressure
timeFrame: Procedure (While doing acupuncture )
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: the Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01782716: Effect of Different Scoring Systems on Mortality Rates and Length of Hospitalization in Cardiac Surgery Patients
Official title: Effect of Different Scoring Systems on Mortality Rates and Length of Hospitalization in Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Keywords: Mortality
Length
hospitalization
cardiac surgery
patients
Lead sponsor: Cumhuriyet University Hospital
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiac surgery patients

Brief summary: Precise risk estimation of mortality in cardiac surgery patients is often difficult. Main objectives of this study is to calculate mortality probability by two different risk score system and to inquire effects of informing anesthesiologist and surgical team; of score of the patient; on length of hospitalization and intensive care and also on actualized mortality.


Eligibility criteria: Inclusion Criteria:

* ASA anesthesia risk group 2-5 patients between 18-70 years of age and with planned cardiac surgery

Exclusion Criteria:

* Terminal malignant diagnosis, multiple organ failure, confirmed brain dead, mechanical ventilation dependent or planned transplantation patients

Primary outcomes:
measure: The number of days the patients treated
timeFrame: 30 days
measure: mortality
timeFrame: With in the 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03151616: Anticholinergic Risk Scale and Resource Use After Elective Noncardiac Surgery
Official title: Association of Anticholinergic Risk Scale and Healthcare Resource Use After Elective Noncardiac Surgery: a Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Length of Stay
Anti Cholinergics
Surgical Procedure, Operative
Aged
Epidemiology
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 244976
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population-based sample of people having their first eligible surgery during the study period

Brief summary: This study investigates the association of preoperative anticholinergic medication exposure with healthcare resource utilization in a population-based sample of older patients enrolled in a universal pharmacare program

Detailed description: Multilevel multivariable regression analysis will be used to investigate the adjusted association between preoperative Anticholinergic Risk Scale and postoperative healthcare resource utilization. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.

Eligibility criteria: Inclusion Criteria:

* at least 66 years old on the day of surgery
* Intermediate to high risk elective noncardiac surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
Secondary outcomes:
measure: Costs of Care
timeFrame: date of surgery up to 90 days after surgery
measure: Institutional Discharge
timeFrame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
measure: Mortality
timeFrame: from day of surgery up to 90 days after surgery
measure: Hospital Readmission
timeFrame: From the date of hospital discharge to 30 days after the date of discharge
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
References:
Clinical trial NCT05799716: Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections
Official title: Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Viremia
Bacteremia
Acute Rejection of Renal Transplant
Keywords: IVIG Infection
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn about the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs. The main questions it aims to answer are:

1. How effective IVIG is in preventing donor-derived infections
2. Does IVIG has potential immunomodulatory effect on transplanted organs

Detailed description: Donor-derived infections are defined as any infection present in the donor that is transmitted to one or more recipient. Donor-derived infections can be categorized into two groups: "expected" and "unexpected" infections. Expected transmissions occur when the donor is known to have an infection, as demonstrated by positive serology or nucleic acid test (NAT) result for cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis B and C, or positive cultures in the donor at the time of donation. Unexpected transmissions may occur despite current screening strategies and are not expected in the donor at the time of organ placement.

Intravenous immunoglobulins (IVIG) are produced by pooling together of serum immunoglobulins from multiple donors, and are known to have powerful immunomodulatory and anti-inflammatory functions in vitro and in vivo. The goal of this study is to figure out the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs.

Eligibility criteria: Inclusion Criteria:

* Any person approved as a transplant donor with recipient who has never undergone a previous transplantation
* Transplant donor must be 6 years old or older
* They must have provided signed informed consent
* The donors must be willing to contribute samples of blood

Exclusion Criteria:

* Any potential transplant donor who is receiving or have received anti-herpes medication in the past week
* Any potential transplant donor to a recipient who has received a previous solid organ transplant
* Any potential transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications
* Any potential transplant donor who is on corticosteroids

Primary outcomes:
measure: Next-Generation Sequencing (NGS) Results of Bacteremia or Viremia in Transplant Recipient
timeFrame: 14 days
measure: Incidence of Bacteremia or Viremia in Transplant Recipient
timeFrame: 14 days
Secondary outcomes:
measure: Incidence of Acute Rejection in Transplant Recipient
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00916916: Lanreotide Levels in Acromegaly
Official title: Lanreotide Levels in Acromegaly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acromegaly
Keywords: Acromegaly
Lanreotide
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2009-06-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Cedars-Sinai Pituitary Center

Brief summary: Recently lanreotide (a somatostatin analog) has come into the US marketplace as a commercially available medication approved by the FDA for the treatment of acromegaly. Blood levels in patients getting this drug are unknown and it may be critical to know the levels in patients whose symptoms are poorly controlled.

This is a clinical study of a medical device where the following condition is met: This is research on a medical device for which an investigational device exemption application (21 CFR Part 812) is not required.

The study is exempt from IDE requirements under 21 CFR 812.2(c)(3):

The participants will be 10 CSMC patients who are taking Lanreotide for clinical purposes. After receiving an information sheet and providing verbal consent, the participants will go to their routine blood draw. At this time, they will have an additional 10 cc plasma drawn, which will be sent to Intersciences Institute in Inglewood California to have the lanreotide plasma levels measured.

The key points of this study are:

Patients will have blood drawn at the same time as they are having blood drawn for routine care to avoid unnecessary sticks.

No patient identifiers will be sent to the lab or to any investigators- all plasma tubes will be coded by ISI as a kit and these kits will be given to the physicians. In turn the physician will give the kit to the patients who wish to have their levels measured and the patient will take the kit with them to their routine blood draw. Following the drawing and processing of the blood we will request that the lab just drop the coded plasma tube (and the patient's height weight and monthly lanreotide dose) into the mail in the prepaid mailer. The only information that the investigators will receive is the patient's height, weight and monthly lanreotide dose and the plasma lanreotide level.

No more than 10 cc of blood (a couple of tablespoons) will be drawn for lanreotide measurement.

Whenever possible plasma (which would otherwise be discarded) will be used rather than freshly drawn blood.

All plasma will be assayed at ISI.

The patient will not be charged for the lanreotide assay, an investigational assay. The assay is currently investigational and does not have a "maker" at this time.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Receiving lanreotide depot for treatment of acromegaly

Exclusion Criteria:

* Unwilling to provide consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References:
Clinical trial NCT00087516: Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)
Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-07-13
Enrollment: 741
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: The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* Patient is not pregnant or breastfeeding
* Male or female patient unlikely to conceive
* Patient not on an antihyperglycemic drug

Exclusion Criteria:

* Patient has history of type 1 diabetes mellitus
* Patient has history of ketoacidosis
* Patient requires insulin within 8 weeks prior to start of study
* Patient on weight loss program and is not in maintenance phase
* Patient taking weight loss medication within 8 weeks prior to start of study
* Patient on or likely to require = 14 days or repeated courses of corticosteroids
* Patient taking immunosuppressive/immunomodulating medication
* Patient taking digoxin or other cardiac medication
* Patient has undergone surgical general anesthesia within 30 days prior to start of study
* Patient taking investigational drug within 8 weeks prior to start of study
* Patient is diagnosed with liver disease
* Patient has chronic myopathy, progressive neurological/neuromuscular disorder
* Patient has with severe cardiac conditions within the last 6 months
* Patient is Human immunodeficiency virus (HIV) positive
* Patient has hematological disorder
* Patient has history of malignancy
* Patient has history of alcohol or drug abuse within the past 3 years

Primary outcomes:
measure: Change From Baseline in A1C at Week 24
timeFrame: Weeks 0-24
Secondary outcomes:
measure: Change From Baseline in FPG at Week 24
timeFrame: Weeks 0-24
measure: Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24
timeFrame: Weeks 0-24
measure: Change From Baseline in A1C at Week 104
timeFrame: Weeks 0-104
measure: Change From Baseline in FPG at Week 104
timeFrame: Weeks 0-104
measure: Change From Baseline in 2-hr PMG at Week 104
timeFrame: Weeks 0-104
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.
Clinical trial NCT02525016: Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery
Official title: Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Bariatric Surgery
Keywords: Bariatric surgery, lidocaine, plasmatic concentration, MonoEthylGlycineXylidide (MEGx), safety
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. As previously published in literature the investigators use it during bariatric surgery.

Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use.

Investigators propose in this work to bring an objective proof that administration of lidocaine based on a modified body weight is safe.

Intravenous administration concerned the peri operative period. A total of six samples are taken for each patient.

Investigators get approbation of local ethic committee for this work.


Eligibility criteria: Inclusion Criteria:

* Adult who perform a bariatric surgery (sleeve, by-pass, mini by-pass) under laparoscopy
* Body mass index \> = 40 kg/m2
* Informed consent signed
* Patient treated with intravenous administration of lidocaine

Exclusion Criteria:

* Contraindication to lidocaine use (allergy, atrioventricular block, seizure, porphyria)
* Concomitant use of beta blocker and others anti arrhythmic drugs
* Cardiac or hepatic insufficiency
* Pregnancy

Primary outcomes:
measure: Plasmatic concentration of lidocaine
timeFrame: From bolus to day 1 after cessation of administration
Secondary outcomes:
measure: occurence of adverse events related to lidocaine use
timeFrame: Up to 2 days after surgery
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Hôpital Edouard Herriot - Département d'anesthésie réanimation
Study officials:
References:
citation: Carabalona JF, Delwarde B, Duclos A, Le Goff MC, Moulsma M, Citterio-Quentin A, Bouffard Y, Rimmele T. Serum Concentrations of Lidocaine During Bariatric Surgery. Anesth Analg. 2020 Jan;130(1):e5-e8. doi: 10.1213/ANE.0000000000003905.
Clinical trial NCT02522416: A Comparison of Two Devices for Measuring the Central Thickness of the Cornea Before and After Surgery (CECOT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders, Refractive
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for whom a LASIK refractive surgery at the Adolphe de Rothschild ophthalmologic foundation is planned

Brief summary: Corneal topography allows the measure of the radii of curvature and of the thickness of the cornea. It is essential for diagnosis in ophthalmology and allows to highlight corneal irregularities such as a keratoconus, or too thin corneas which are a contra-indication for laser refractive surgery.

Several types of corneal topographers are commercially available. Some as the Orbscan(r), operate by analyzing the image of the patterns of a Placido disk associated with a light slit, allowing the collection of thousands of points of the anterior and posterior surface of the cornea. More recent systems such as the Pentacam(r) are based on automatic rotary cameras which capture images of the whole anterior segment of the eye. The aim of this study is to compare two topographs, the Pentacam(r) and the Orbscan(r) and, more specifically, the central corneal pachymetry measurements measured pre- and postoperatively.


Eligibility criteria: Inclusion Criteria:

* Patients for whom a LASIK refractive surgery is planned

Exclusion Criteria:

* hyperopic patient
* another refractive surgery technique
* pregnant or lactating woman
* patient's opposition to participation in the study, according to the law on research into routine care
* patient under a measure of legal protection
* absence of affiliation to social security

Primary outcomes:
measure: Concordance of the Orbscan and Pentacam topographs, evaluated by the intra-class correlation coefficient, for the measure of the difference of the central thickness of the cornea before and after surgery.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmique Adolphe de Rothschild
Study officials:
References: