louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01495845: Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy
Official title: Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Transient Ischemic Attack
Myocardial Infarction
Keywords: pharmacogenomics
feasibility
community pharmacy
personalized medicine
clopidogrel
Plavix
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Kerr Drug
name: Laboratory Corporation of America
First posted: 2011-12-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine the feasibility of pharmacogenomics testing in a community pharmacy using clopidogrel as an example. The investigators hypothesize that this testing is feasible in this setting.

Detailed description: To determine if the study is feasible, we will examine the change in patient perception of pharmacogenomics testing (before and after the study), the percentage of patients interested in this service, the response rate of providers to pharmacist recommendations, the pharmacist time requirement, and reimbursement rate for pharmacist services.

Eligibility criteria: Inclusion Criteria:

* Prescribed clopidogrel (Plavix) by their prescriber
* Aged 18 or older
* Currently on clopidogrel therapy for one of the following indicated uses: post-ACS, Recent PCI with stenting, History of TIA or stroke

Exclusion Criteria:

* Are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients
* Are taking clopidogrel for a reason other than stated in inclusion criteria
* Are pregnant or nursing
* Have an allergy to aspirin

Primary outcomes:
measure: Feasibility of Pharmacogenomics testing in a Community pharmacy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Kerr Drug
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Stefanie Ferreri, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00583245: Improving Walking in Older Adults With Knee Osteoarthritis
Official title: Optimizing Mobility in Older Adults With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Gait training
Knee pain
Rehabilitation
Physical Therapy
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2007-12-31
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The long-term objective of this research is to reduce disablement of older adults with symptomatic knee OA. The principle of specificity of training indicates that exercises that closely approximate the goal functional activity are most effective in improving physical performance during that activity. Based on this principle, the specific aim of this pilot study is to design a patient-specific gait training intervention using analysis of compensatory joint moments and energy expenditure. Successful completion will inform rehabilitation for maintaining or improving mobility as well as explore the mechanism of effect.


Eligibility criteria: Inclusion Criteria:

* Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by x-ray and frequent knee symptoms)
* Age 60 or older

Exclusion Criteria:

* acute or terminal illness
* unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring the use of supplemental oxygen, neurological disease that affects gait, or lower limb musculoskeletal surgery in the past 6 months.
* Bilateral knee replacement

Primary outcomes:
measure: Changes in functional limitation assessed by the A) Summary Performance Score which includes balance tests, timed 4-meter walk, and timed chair stand test B) Timed stair climb C) Late Life Function and Disability Instrument (LLFDI) Questionnaire
timeFrame: 12 weeks
measure: Changes in the disability measure, a timed 400 meter walk
timeFrame: 12 Weeks
measure: Changes in impairments assessed using the Knee and Osteoarthritis Outcome Score (KOOS) questionnaire
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Neil Segal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02448745: Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria, Falciparum
Anemia
Lead sponsor: The Mentor Initiative
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Liberia
First posted: 2015-05-19
Enrollment: 6317
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A cluster-randomized control trial will study the effect of insecticide-treated wall lining on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study will receive insecticide-treated wall lining covering their walls and ceilings in addition to long-lasting insecticidal nets, while the other half will be protected by existing long-lasting insecticidal nets.

Detailed description: Long-lasting insecticidal nets (LLINs) are the established vector control product for malaria control. In Bomi County Liberia, LLINs have been distributed but malaria prevalence in children under 5 remains high, with prevalence in study villages found to be 42% in April 2014. The major malaria vector species are resistant to pyrethroid insecticides approved for use in LLINs, and new control measures with non-pyrethroid active ingredients may protect the population.

Eligibility criteria: Inclusion Criteria:

* Child resides in village
* Child presents with parent or guardian

Exclusion Criteria:

* Child or guardian has history of Ebola exposure
* Child has 3 symptoms of Ebola

Primary outcomes:
measure: Malaria Prevalence
timeFrame: 6 months
Secondary outcomes:
measure: Hemoglobin
timeFrame: 6 months
measure: Fever
timeFrame: 6 months
measure: Mosquito biting rate.
timeFrame: 2 months
Other outcomes:
Locations:
city: Tubmanburg
country: Liberia
facility: Bomi County Health Team
state: Bomi County
Study officials:
affiliation: Study Coordinator
name: David J Giesbrecht, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00988845: Indole-3-Carbinol Effects on Estrogen Metabolism
Official title: Effects of Dietary Indole-3-Carbinol on Estrogen Metabolites Across a Wide Range of Body Mass Index: Implications for the Prevention of Endometrial Cancer in Obese Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Keywords: dietary supplement
indole 3 carbinol
estrogen
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-10-02
Enrollment: 38
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen profile in women across a range of body mass index.


Eligibility criteria: Inclusion Criteria:

* woman aged from 30 - 50 years
* regular menstrual cycle

Exclusion Criteria:

* taking hormone replacement or hormonal contraception
* thyroid disorder
* uncontrolled asthma
* BMI under 18.5
* allergy to cruciferous vegetables

Primary outcomes:
measure: Change in urinary 2/16-hydroxyestrone ratio
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Joseph P Connor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02840045: Development of a New Neuroimaging Method Aimed to Differentiate Mnesic Abilities of Alzheimer and Depressed Patients
Official title: Development of a New Neuroimaging Method Aimed to Differentiate Mnesic Abilities of Alzheimer and Depressed Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Depression
Keywords: electroencephalography (EEG)
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to use a new method to differentiate mnesic abilities of early alzheimer patients and patients with a depressive disorder.

This method is based on the recording of cerebral activity while patients listen to familiar, unfamiliar and newly-learned music.


Eligibility criteria: Inclusion Criteria:

* Being right-handed
* recorded consent
* For Alzheimer patients: Mini Mental Status Examination (MMSE) score \>= 18
* For patients with a depressive disorder : Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) and Montgomery-Asberg depression rating scale (MADRS) score \>= 25
* For healthy controls : no cognitive deficit, MADRS score \< 25, no depressive disorder according to DSM IV

Exclusion Criteria:

* Auditory deficit
* contraindication to a high-density electroencephalography exam
* refusal to participate in the study

Primary outcomes:
measure: Amplitude of event-related potentials
timeFrame: day 1 for familiar and unfamiliar songs and day 14 for newly learned songs
Secondary outcomes:
measure: Spectral power
timeFrame: day 1 for familiar and unfamiliar songs and day 14 for newly learned songs
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHRU Besançon
state: Franche-Comte
Study officials:
affiliation: Service de psychiatrie
name: Pierre Vandel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gabriel D, Wong TC, Nicolier M, Giustiniani J, Mignot C, Noiret N, Monnin J, Magnin E, Pazart L, Moulin T, Haffen E, Vandel P. Don't forget the lyrics! Spatiotemporal dynamics of neural mechanisms spontaneously evoked by gaps of silence in familiar and newly learned songs. Neurobiol Learn Mem. 2016 Jul;132:18-28. doi: 10.1016/j.nlm.2016.04.011. Epub 2016 Apr 27.
Clinical trial NCT00000245: Evaluation of a Desipramine Ceiling in Cocaine Abuse - 1
Official title: Evaluation of a Desipramine Ceiling in Cocaine Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Friends Research Institute, Inc.
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm whether a blood level ""ceiling"" exists on desipramine effect in cocaine abuse.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Craving
measure: Retention
measure: Cocaine use
measure: Depression
measure: Anxiety
measure: Mood indicators
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Frank Gawin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06009445: Renal Resistive Index as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis
Official title: Renal Resistive Index by Renal Doppler Ultrasound as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis Patients: Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Resistive Index
Acute Kidney Injury
Sepsis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Tanta university surgical intensive care unit (SICU)

Brief summary: We aim from this study to investigate the role of renal resistance index (RRI) in evaluation of Acute kidney injury development and fluid administration in sepsis patients considering the change in RRI values over 7 days from admission as a predictor of AKI development

Detailed description: Acute kidney injury (AKI) is one of the most common problems in critically ill patients in the clinic. AKI can be caused by various factors, such as hypovolemia, shock, major surgery, trauma, and heart failure, of which sepsis is the most common

Eligibility criteria: Inclusion Criteria:

* Age over 21 years
* meet Sepsis 3 criteria (potential source of infection , host response and organ dysfunction) but not in septic shock.

Exclusion Criteria:

* patients during pregnancy.
* patients with hepatorenal syndrome.
* Poor abdominal echogenicity eg.(morbid obesity ,increase intra abdominal pressure )
* Severe acute or chronic renal insufficiency .
* Dialysis dependency.
* Renal transplantation.
* Known renal artery stenosis.
* Mono-kidney, kidney tumor, anatomic kidney abnormalities.

Primary outcomes:
measure: Prediction of AKI development by renal resistance index (RRI)
timeFrame: 7 days from admission
Secondary outcomes:
measure: Evaluation of fluid administration
timeFrame: 7 days from admission
measure: Length of ICU stay
timeFrame: 2 months from admission till discharge
measure: cumulative fluid balance over 7 days
timeFrame: 7 days from admission
measure: The incidence of 28 day mortality
timeFrame: 28 days from admission
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Elgharbia
Study officials:
affiliation: Anesthesiology, Faculty of Medicine, Tanta University, Egypt.
name: Safinaz A Aboelfetoh, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01621945: Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 in Patients Having to be Vaccinated MenBVac® (Extension EFFIVAC)
Official title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Neisseria Meningitidis B:14,P1.7,16 Strain in Child
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neisseria Meningitidis
Keywords: Neisseria meningitidis B:14, P1-7, 16
Serum bactericidal activity
OMV vaccine
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Direction Générale de la Santé, France
name: Institut Pasteur
First posted: 2012-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 4 to 8 years old and living in neufchatel en bray area

Brief summary: The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (\>= 4), before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.


Eligibility criteria: Inclusion Criteria:

* children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray,and Having participated to the first study,
* children who Have to be Vaccinated MenBVac® for the four times,
* parental authority(ies)assent.

Exclusion Criteria:

* no parental authority(ies)assent,
* no blood sample,
* impossibility of fourth vaccination,
* children yet vaccinated or non eligible for vaccination.

Primary outcomes:
measure: Vaccine Immunity
timeFrame: after the fourth dose of MenbVac
Secondary outcomes:
Other outcomes:
Locations:
city: Neufchâtel En Bray
country: France
facility: Maison Du Département
Study officials:
References:
Clinical trial NCT02195245: A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate
Official title: A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Tidal CO2
CO2 Removal
Keywords: CO2 filter
anesthesia
device
Lead sponsor: DMF Medical Incorporated
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the problem of organ-toxin production in anesthetic circuits.

Detailed description: CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the problem of organ-toxin production in anesthetic circuits.

This new absorber can be easily integrated into any anesthesia circuit, and can effectively remove CO2 without reacting with anesthetic drugs, thus eliminating organ-toxic by-products.

It uses advanced membrane technology to separate gas flows within the circuit, separating the expensive anesthetic vapors from the CO2 (the main by-product of metabolism). Anesthetic vapors thus remain in the closed loop circuit, while CO2 is separated and exhausted to the atmosphere, rather than being absorbed through a chemical reaction.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology Physical Status Class I, II, III (low-medium risk patient)
* English-speaking patients
* Scheduled for elective surgery
* Length of anesthesia ≥ 60 minutes

Exclusion Criteria:

* Pregnant
* American Society of Anesthesiology Physical Status Class IV (high risk patient)
* Patients schedule for emergency surgery
* Known respiratory disease, including COPD and severe asthma
* Have elevated pressure in your brain (intra cranial pressure, ICP)

Primary outcomes:
measure: End tidal CO2 level
timeFrame: Continuous (5min intervals) over duration of anesthesia. No data collection prior or post anesthesia.
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II HSC, Halifax Infirmary Site
state: Nova Scotia
Study officials:
References:
Clinical trial NCT02217345: Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Official title: Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United States. A subset of these will develop progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy (1H-MRS).


Eligibility criteria: Inclusion Criteria:

1. Ages 18 - 65 yr
2. NAFLD defined as demonstration of hepatic steatosis by imaging or biopsy in absence of significant alcohol consumption and other causes of hepatic steatosis. If liver imaging or biopsy has not been performed clinically, liver ultrasound will be performed as part of the screening visit.

Exclusion Criteria:

1. Serum creatinine \> 2 times the upper limit of normal
2. History of cancer, except for non-melanoma skin cancers
3. Active carpel tunnel syndrome
4. Diabetes mellitus, defined as a hemoglobin A1C \>6.5 or use of any medications prescribed to treat hyperglycemia. The exception is that the use of metformin is acceptable in patients whose HbA1c has been =\<6.0 on two visits and whose weight has remained stable for six months.
5. Contraindications to magnetic resonance imaging (MRI).
6. Pregnancy or desire to become pregnant. Participants of reproductive age must agree to use contraception.
7. Breastfeeding
8. Aspartate and aminotransferase levels \>10x upper limit of normal

Primary outcomes:
measure: Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6 Months.
timeFrame: 6 months
Secondary outcomes:
measure: Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months.
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen K Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: