louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00589680: Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis
Official title: Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Ketoacidosis
Keywords: Acidosis, Diabetic
Diabetic Acidosis
Diabetic Ketosis
Ketoacidosis, Diabetic
Ketosis, Diabetic
Lead sponsor: Marshall University
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Those patients admitted to St. Mary's Medical Center with a diagnosis of DKA.

Brief summary: At this time, Saint Mary's Medical Center is currently in the process of implementing a standardized diabetic ketoacidosis (DKA) protocol. The first main goal of this project will be to evaluate patient outcomes to determine the effects of treating patients without a standardized protocol and to establish a baseline on how patients are being treating with DKA. The final goal of the project will be to compare outcomes of those patients not placed on the protocol to those that were treated using SMMC newly implemented DKA protocol. The overall goal of this project is to determine the benefit of an institutional DKA protocol.


Eligibility criteria: Inclusion Criteria:

* Admitted to St. Mary's Medical Center with DKA
* \>/= 18 years of age

Exclusion Criteria:

* \< 18 years of age

Primary outcomes:
measure: Hospital length of stay
timeFrame: Time in hospital
Secondary outcomes:
measure: ICU length of stay
timeFrame: hospital stay
measure: ICU length of stay Hypoglycemic events (BG<60)
timeFrame: hospital stay
measure: Time to correction of glucose level and anion gap
timeFrame: hospital stay
Other outcomes:
Locations:
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
Study officials:
affiliation: St. Mary's Medical Center
name: Sharon Jones, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01673880: Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations
Official title: A Single-center, Open-label, Randomized, Multi-cohort, Crossover Study of Relative Bioavailability of Tablet Versus Capsule Formulation of E2006 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insomnia
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-center, open-label, randomized crossover study being conducted in three cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.


Eligibility criteria: Inclusion:

* Healthy males or females,
* ages 18 to 55 years
* Body mass index (BMI) \&gt;
* 18 and 32 kg/m2 at Screening

Exclusion:

* Female subjects who are nursing
* Subjects with a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profiles of E2006
* Subjects with a known history of clinically significant drug or food allergies
* Subjects with a known allergy or hypersensitivity to capsule or tablet ingredients

Primary outcomes:
measure: Plasma concentrations of E2006 of tablet vs. capsule formulations
timeFrame: up to 336 hours post-dose
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 36 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LLC
state: Texas
Study officials:
affiliation: PPD Development, LP
name: Aziz Laurent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00541580: Comparative Results of Conservatively and Surgically Treated Adolescents With Triplane and Juvenile Tillaux Ankle Fractures After Skeletal Maturity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ankle Injuries
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-10-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adolescents with triplane and juvenile Tillaux ankle fractures

Brief summary: Triplane and Juvenile Tillaux fractures of the ankle are well known in adolescent pediatric population. It is widely accepted, that optimal treatment for displaced fractures is close or open reduction and fixation with screws under general anesthesia and under intraoperative fluoroscopy control. Usually a small degree of displacement (up to 2mm) is expected to be healed without any sequences. Until now, no evidence of ankle function and pain after skeletal maturity or long follow-up was published. More than that, no comparative study between operative and no operative treatment of mild and borderline displaced fractures were published.

The purpose of this study is to evaluate functional and radiographic results of operatively and conservatively treated patients after they reach skeletal maturity.


Eligibility criteria: Inclusion Criteria:

* Sign informed consent.

Exclusion Criteria:

* Pregnancy
* Unwillingness to sign the informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Vladimir Goldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Neum Simanovsky, MD
role: STUDY_DIRECTOR
affiliation: Hadassah Medical Organization
name: Natalia Simanovski, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00004380: Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Sclerosis
Keywords: arthritis & connective tissue diseases
rare disease
systemic sclerosis
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Stanford University
First posted: 1999-10-19
Enrollment: 1
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma).

II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and cultured from skin biopsies.

Detailed description: PROTOCOL OUTLINE: This is a compassionate use study. The patient is treated with subcutaneous injections of recombinant relaxin for approximately 12 months. If clinically indicated, therapy may be extended.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Progressive systemic sclerosis (scleroderma)
* No pregnant or nursing women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: G. Scott Herron
role: STUDY_CHAIR
References:
Clinical trial NCT00629980: Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis
Official title: A Multi-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone in Subjects With Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blepharitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 60
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: The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.


Eligibility criteria: Inclusion Criteria:

* diagnosis of moderate to severe chronic blepharitis
* if female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

* had ocular surface surgery (LASIK, refractive, etc.) within the past year
* unwilling to discontinue the use of contact lenses during the study
* have glaucoma
* unable or unwilling to withhold the use of lid scrubs during the study
* have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
* currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation

Primary outcomes:
measure: change in clinical signs and symptoms associated with blepharitis
timeFrame: 4 weeks
Secondary outcomes:
measure: standard ocular safety assessments
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Louisville
country: United States
facility: Kentuckiana Institute for Eye Research
state: Kentucky
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Wantagh
country: United States
facility: South Shore Eye Care, LLP
state: New York
city: Jackson
country: United States
facility: Toyos Clinic
state: Tennessee
city: El Paso
country: United States
facility: Corona Research Consultants, Inc.
state: Texas
Study officials:
affiliation: Sponsor GmbH
name: Reza Haque, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04745780: Evaluation of Efficacy and Safety of a Combination Containing Myo-inositol, D-chiro-inositol, Alpha-lactalbumin, Zinc and Extract of Gymnema Sylvestre in Subjects Diabetic Patients.
Official title: Randomized, Controlled, Open-label Study to Evaluate the Efficacy and Safety of a Combination Containing Myo-inositol, D-chiro-inositol, Alpha-lactalbumin, Zinc and Extract of Gymnema Sylvestre in Subjects With Type 2 Mellitus Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Myo-inositol
Gymnema sylvestre
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mellitus type 2 diabetes (T2MD) is a chronic disease characterized by high glucose plasmatic level due to an alteration of insulin function. Several authors have correlated this altered function to an inositol depletion. The main present member of inositol family in biological systems is undoubtedly myo-inositol, a precursor of several second messengers, widely involved in insulin signalling. For this reason this molecule is considered an insulin-sensitizer. The high excretion of inositol in T2MD patients is frequent, inducing a myo-inositol depleted state that favours the onset of insulin resistance, impairing the activity of this hormone. The aim of this study is to evaluate the efficacy and the safety of a food supplement containing myo-inositol in T2MD patients.


Eligibility criteria: Inclusion Criteria:

* With diagnosis of Type 2 Mellitus Diabetes for at least 1 year
* Levels of Hb1Ac ranging from 7.5% to 9.0%

Exclusion Criteria:

* Patients that require insulin treatment
* Treated at baseline with food supplements or drugs containing Myo-inositol, D-chiro-inositol, alphalactalbumin, zinc, or Gymnema Sylvestre;
* Any contraindications to the treatment or to any substance used for the treatment
* Subjects with intestinal malabsorption
* Patients subjected to surgery within 6 months before baseline;
* Chronic treatment with systemic corticosteroids

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: up to 6 months of treatment
Secondary outcomes:
measure: Glycemia
timeFrame: At baseline and 3 and 6 months of treatment
measure: Cholesterol
timeFrame: At baseline and 3 and 6 months of treatment
measure: Hypoglycemic events
timeFrame: At baseline and 3 and 6 months of treatment
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Basilio Pintaudi
Study officials:
References:
Clinical trial NCT04191980: Deep Learning for Prostate Segmentation
Official title: Multi-zone Computer-aided Prostate Segmentation on MR Images Using a Deep Learning-based Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: prostate segmentation
MR images
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Random selection in the Picture Archiving and Communication System (PACS) of the Hospices Civils de Lyon among examinations performed between 2016 and 2019

Brief summary: Because the diagnostic criteria for prostate cancer are different in the peripheral and the transition zone, prostate segmentation is needed for any computer-aided diagnosis system aimed at characterizing prostate lesions on magnetic resonance (MR) images. Manual segmentation is time consuming and may differ between radiologists with different expertise. We developed and trained a convolutional neural network algorithm for segmenting the whole prostate, the transition zone and the anterior fibromuscular stroma on T2-weighted images of 787 MRIs from an existing prospective radiological pathological correlation database containing prostate MRI of patients treated by prostatectomy between 2008 and 2014 (CLARA-P database).

The purpose of this study is to validate this algorithm on an independent cohort of patients.


Eligibility criteria: Inclusion Criteria:

* Prostate MRI contained in the PACS of the Hospices Civils de Lyon
* Performed in 2016-2019

Exclusion Criteria:

* MRIs from patients who already had treatment for prostate cancer

Primary outcomes:
measure: Mean Mesh Distance (Mean) between the contours of the whole prostate made by the algorithm and the two radiologists
timeFrame: Month 11
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
References:
Clinical trial NCT03149380: Effectiveness of Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior
Official title: Evaluating the Effectiveness of Web-based Education Via Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer Disease
Alzheimer Disease, Late Onset
Memory Loss
Patient Education as Topic
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the effectiveness of an online educational course on Alzheimer's disease (AD) prevention, treatment and caregiving.

Detailed description: Alzheimer's Universe (www.AlzU.org) was created to provide online education about Alzheimer's disease (AD), with a focus on family members of people with AD, people with mild cognitive impairment due to AD and mild AD, caregivers, healthcare providers, medical students, college students and high school students. The website provides evidence-based courses with interactive lessons and activities that have been shown to increase knowledge about AD, willingness to participate in an AD prevention clinical trial, and intent to make specific lifestyle changes in effort to reduce AD risk.

Eligibility criteria: Inclusion Criteria:

* greater than or equal to 14 years old with a friend, family member or acquaintance with Alzheimer's disease or memory loss, OR a person diagnosed with mild memory loss (including mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease), OR an AD caregiver, OR healthcare providers, OR a medical student, college student or high school student.

Exclusion Criteria:

* \< 14 years old, OR diagnosis of moderate or severe Alzheimer's disease

Primary outcomes:
measure: Knowledge of AD Preventative behaviors
timeFrame: 12 months
measure: Willingness to Engage in AD Preventative behaviors
timeFrame: 12 months
Secondary outcomes:
measure: Participant Satisfaction
timeFrame: 12 months
measure: Behavioral Assessments
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Richard Isaacson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00726180: Use of Trastuzumab to Induce Increased ER Expression in ER-negative/Low, Her-2/Neu Positive Breast Cancer
Official title: Evaluation of the Use of Trastuzumab to Induce Increased ER Expression in ER-Negative/Low, Her-2/Neu Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer
Women
w/Her2
positive
ERnegative
not metastasized
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2008-07-31
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The majority pf breast cancers present as ER-positive, many of which are able to be targeted with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has the potential to benefit patients by making hormonal therapies a therapeutic option and possibly improving their overall prognosis.


Eligibility criteria: Inclusion Criteria:

* Women who have Her-2 positive and ER- negative or ER-low breast cancer that has not metastasized, or spread to other parts of the body, are eligible for the study.
* Participants must have had either a core biopsy or incisional biopsy of their breast cancer, but not yet had definitive breast surgery, including lumpectomy or mastectomy.
* Participants may not have had a BRCA mutation found on genetic testing.
* Participants should have not yet received treatment for their breast cancer, including:

  * chemotherapy,
  * hormonal therapy,
  * trastuzumab.

Primary outcomes:
measure: Standard Immunohistochemistry and Allred Scores Were to be Used to Measure the Estrogen Receptor (ER) Response Rate in Patients With ER-negative/Low, and Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-positive Breast Cancer.
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Anne Schott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02007980: Indwelling Stent Discoloration Project
Official title: Examining the Underlying Factors That Cause Ureteral Stent Discoloration in Japanese and Canadian Ureteral Stents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urologic Injuries
Disorder of Urinary Stent
Kidney Calculi
Urinary Tract Obstruction Due to Specified Cause
Hydronephrosis
Keywords: urological problems
indwelling urologic stent
kidney stone disease
urinary system obstruction
hydronephrosis
ureteral damage
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver General Hospital
First posted: 2013-12-11
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with indwelling ureteral stent due to urologic indication.

Brief summary: The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents.

Detailed description: The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents observed in some patients, particularly those from Japan. We will also test and compare them to stents from Canadian patients. Furthermore, we will determine whether the discolouration promotes bacterial adhesion and/or encrustation of the stent.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 19 years of age (Vancouver, British Columbia, Canada - for Japan different age limit as applicable)
* Patient has indwelling ureteral stent

Exclusion Criteria:

* Pregnancy
* Positive Urine Culture
* Active cancer
* Recurrent urinary infections
* Gross hematuria
* Inability to provide informed consent
* Physician/Surgeon refuses to enter patient into study

Primary outcomes:
measure: stent encrustation
timeFrame: at stent removal
Secondary outcomes:
measure: characterize the components that discolour the Percuflex material
timeFrame: bench top testing of stents
measure: Bacterial Adhesion, Colonization, and Biofilm formation
timeFrame: at 4, 24, and 48 hours post stent removal
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: UBC/VGH
name: Ben Chew, MD
role: PRINCIPAL_INVESTIGATOR
References: