louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01801254: Using EEG Operant Conditioning to Improve Trait Self-Control and Promote Healthy Behavior
Official title: Using EEG Operant Conditioning to Improve Trait Self-Control and Promote Healthy Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Type II Diabetes
Cardiovascular Disease
Health Behavior
Keywords: Obesity
Type II diabetes
Cardiovascular disease
Health behavior promotion
Neuroeconomics
EEG biofeedback
Low-resolution electromagnetic tomography (LORETA)
EEG
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 16
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 field of neuroeconomics has begun to elucidate neural mechanisms underlying self-control; however, researchers have not yet harnessed neuroeconomics findings to develop interventions for improving self-control ability. The investigators are currently developing such an intervention. The investigators' approach involves using a brain-computer interface with audiovisual feedback to show people what is happening in their own brains, in real time. Through this interface, individuals are trained to increase levels of neural activity that may facilitate self-control, which, in turn, may improve the ability to exhibit self-controlled behaviors. This may increase the ability to engage in heath behaviors for which self-control is required (eg, dieting and exercising). The investigators' long-term goal is to create a tool that will help people develop the self-control needed to achieve lasting improvements in health behaviors.


Eligibility criteria: Inclusion Criteria:

* Can read and write fluently in English
* At least 18 years of age
* Right-handed
* Overweight or obese (BMI \> 24.9)
* Currently has a University of Rochester meal plan
* Currently in contemplation or action stages of change with respect to weight loss (measured with the Weight Stages of Change Algorithm; Rossi, Rossi, Velicer, \& Prochaska, 1995).

Exclusion Criteria:

* History of diabetes, epilepsy, celiac disease, lactose intolerance, food allergies, veganism, mental illness, or eating disorders
* Currently taking a medication that may have a strong effect on EEG recordings (eg, an antidepressant, stimulant medication, etc.)
* Currently drinks more than 3 cups of coffee per day or roughly equivalent caffeine intake

Primary outcomes:
measure: postprandial blood glucose and triglycerides
timeFrame: 4 times per week for 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Jordan Silberman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02768454: Antimicrobials Stewardship by Pharmacist
Official title: Appropriate Use of Controlled Broad-spectrum Antimicrobials by Establish Stewardship and Execute by Antibiotic Pharmacist
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Keywords: broad-spectrum antimicrobial
antibiotics pharmacist
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the investigators randomly do medical chart review of patients received broad-spectrum antibiotics from their hospital systems.

Brief summary: To study the outcome of antibiotics stewardship

Detailed description: Retrospective cohort study by medical review and evaluation of broad-spectrum antibiotics to determine how appropriately it was bing used.

Eligibility criteria: inclusion criteria:

* Inpatient with infectious disease and under broad-spectrum antibiotics

exclusion criteria:

* Poor prognosis was diagnosed or received conservative therapy only.

Primary outcomes:
measure: The percentage of appropriateness of empirical antibiotics choosing.
timeFrame: up to 8 weeks
measure: The percentage of appropriateness of de-escalation of therapy.
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Number of adverse events of antibiotics were recorded.
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Yun-Lin
country: Taiwan
facility: National Taiwan University Hospital
state: Dou-Liou
Study officials:
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Shu-Chen Yang, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00338754: Adalimumab in Adult Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Phase 2/3, Randomized, Double-Blind, Placebo Controlled, Multicenter Study of Efficacy and Safety of Adalimumab in Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Eisai Limited
First posted: 2006-06-20
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy and safety of repeated administration of adalimumab in adult Japanese subjects with moderate to severe chronic plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Subject was age 20 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis

Exclusion Criteria:

* Subject had previously received anti-TNF therapy.
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVA, UVB or PUVA phototherapy
* Subject is taking or requires oral or injectable corticosteroids
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant

Primary outcomes:
measure: Proportion of subjects with clinical response relative to Baseline PASI score
Secondary outcomes:
measure: QoLs
measure: Clinical response indicators
measure: Safety parameters
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kanto
country: Japan
city: Kinki
country: Japan
city: Kyusyu
country: Japan
city: Shikoku
country: Japan
city: Tohoku
country: Japan
Study officials:
affiliation: Abbott Japan Co.,Ltd
name: Noritaka Inomata, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04988854: Using Models' Facial Expressions to Enhance Healthy Eating Behaviour in Children
Official title: Using Models' Facial Expressions to Enhance Healthy Eating Behaviour in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Keywords: Children
Lead sponsor: Aston University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 117
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children were randomly assigned to one of three conditions (positive, neutral or control)
Primary purpose: OTHER

Brief summary: This study examined the effect of adults' facial expressions (FEs) whilst eating raw broccoli on children's acceptance and intake of a typically less preferred vegetable. Investigating others' FEs in isolation (e.g., without statements about food tastiness) will improve understanding of the role of FEs in modelling of eating and contribute to developing strategies to help children learn pleasure from nutritious foods. Based on previous literature, it was hypothesised that children's acceptance (willingness to try, and frequency of taste exposures) and intake of raw broccoli would be higher after exposure to models eating raw broccoli with positive FEs, compared to models consuming raw broccoli with neutral FEs, or a non-food control video.

Detailed description: Research has shown that seeing positive facial expressions towards food are effective for increasing children's desire to eat foods rated as disliked. However, the effect of adults' positive facial expressions whilst eating a raw vegetable on children's acceptance and consumption of nutritious foods that are less preferred (e.g., vegetables) remains to be established. This study examined the effect of unfamiliar adult models' facial expressions eating raw broccoli on children's acceptance and consumption of raw broccoli. Children aged 4-6-year-olds were randomised to watch a video of unfamiliar adult models eating raw broccoli with a positive or neutral facial expression, or a non-food control video. Children's acceptance (willingness to try and frequency of taste exposures) and consumption of raw broccoli was assessed. Data about parent and child characteristics was provided by parents.

Eligibility criteria: Inclusion Criteria:

* Child must be aged 4-6-years old. Parent and child must be living in the UK.

Exclusion Criteria:

* Children with food allergies, food intolerances, or medical conditions that affect eating behaviour were not eligible to take part.

Primary outcomes:
measure: Raw broccoli intake
timeFrame: 5 minutes
measure: Willingness to try raw broccoli
timeFrame: 5 minutes
measure: Frequency of taste exposures to raw broccoli
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Aston University
Study officials:
affiliation: Aston University
name: Katie Edwards, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01500954: Microarray Analysis of microRNA Expression Profiles in Cutaneous Squamous Cell Carcinoma
Official title: Microarray Analysis of microRNA Expression Profiles in Cutaneous Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Squamous Cell Carcinoma
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cutaneous squamous cell carcinoma

Brief summary: MicroRNAs (miRNAs) are a novel class of short RNAs which have shown to be dysregulated in a variety of cancers. Data of miRNA expression in cutaneous squamous cell carcinoma (cSCC) is very limited and microarray based genome wide miRNA expression profiles of cSCC have not been investigated so far.

Detailed description: Patients with cutaneous SCC were enrolled in the present study. Tumor biopsies were taken from the center of the tumor. Adjacent healthy skin was biopsied as a control (intraindividual control). miRNA expression profiles of specimen were detected by microarray miRNA expression profiling. Microarray results were confirmed by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

Eligibility criteria: Inclusion Criteria:

* cutaneous squamous cell carcinoma

Exclusion Criteria:

* other skin cancer than cutaneous squamous cell carcinoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Dermatology, Venereology and Allergology, Dermatologic Surgery Unit, Ruhr-University Bochum
state: NRW
Study officials:
affiliation: Department of Dermatology, Venereology and Allergology, Dermatologic Surgery Unit, Ruhr-University Bochum
name: Falk G Bechara, PD Dr.
role: STUDY_DIRECTOR
affiliation: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
name: Peter Altmeyer, Prof. Dr.
role: STUDY_CHAIR
affiliation: Department of Dermatology, Venereology and Allergology, Dermatologic Surgery Unit, Ruhr-University Bochum
name: Michael Sand, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sand M, Skrygan M, Georgas D, Sand D, Hahn SA, Gambichler T, Altmeyer P, Bechara FG. Microarray analysis of microRNA expression in cutaneous squamous cell carcinoma. J Dermatol Sci. 2012 Dec;68(3):119-26. doi: 10.1016/j.jdermsci.2012.09.004. Epub 2012 Sep 13.
Clinical trial NCT00007254: Morphine Gel for Bedsores
Official title: Morphine-Infused Gel for Pressure Ulcer Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Decubitus Ulcer
Keywords: Analgesia
Bedsore
Morphine gel
Pressure ulcer
Pain
Ulcer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2000-12-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tests the effectiveness of a morphine-containing gel for reducing pain caused by pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing morphine, or the gel alone, directly onto painful pressure ulcers and compare the results.

Detailed description: In this study, we will apply a morphine-containing gel (or placebo) directly onto painful pressure ulcers. We will take participants off of any opioid-containing medications upon entry into the study. This allows us to measure any morphine that may enter into the bloodstream from the topically applied gel.

The purpose of this study is to examine the efficacy of the gel for pressure ulcer analgesia, as well as the systemic absorption of morphine from the topically applied gel. We will document the amount of pain medications taken by participants to determine whether the gel decreases the need for these drugs.

Eligibility criteria: Inclusion Criteria:

* Presence of a Stage II pressure ulcer.
* Pressure ulcer must be painful.
* Primary Care physician must approve participation.
* Thinking ability must be clear and intact.
* Willing to change pain medication to oxycodone.

Exclusion Criteria:

* Allergy to morphine, oxycodone or intrasite gel.
* Use of codeine- or morphine-containing medications.
* Use of pain medications for anything other than the pressure ulcer.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Kindred Hospital
state: Missouri
Study officials:
affiliation: The University of Kansas Medical Center
name: Teresa D. Long, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Twillman RK, Long TD, Cathers TA, Mueller DW. Treatment of painful skin ulcers with topical opioids. J Pain Symptom Manage. 1999 Apr;17(4):288-92. doi: 10.1016/s0885-3924(98)00140-7.
Clinical trial NCT02085954: Evaluation of a Training in the Walking With Exosquelette
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gait
Stroke
Robotic Rehabilitation
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: stroke patients follow in our rehabilitation hospital, able to walk alone

Brief summary: Stroke patients in the investigators rehabilitation unit follow gait trainings with robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with 3D gait analysis. The objective of this study is to assess the effects of gait training in Lokomat on biomecanic gait parameters in stroke patients.


Eligibility criteria: Inclusion Criteria:

* single stroke
* able to walk alone
* \> 18years

Exclusion Criteria:

* Cognitive impairments disturbing understanding
* Uncontrolled medical disorder associated

Primary outcomes:
measure: peak knee flexion (degrees)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes:
measure: hip and ankle kinematics (degrees)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: kinetics (newton/meter)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: spatio temporal parameter (m/s)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
References:
Clinical trial NCT01439854: Study of Dapagliflozin on Mitochondrial Dysfunction and Impaired Insulin Signaling/Action
Official title: Regulation of Hepatic and Peripheral Glucose Metabolism: Protocol IVA. Effect of Plasma Glucose Reduction by Selective SLGT2 Inhibition on Mitochondrial Dysfunction and Impaired Insulin Signaling/Sensitivity in T2DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Multiple Mitochondrial Dysfunctions Syndrome
Keywords: Insulin sensitivity
Mitochondrial function
Glucose toxicity
Glucosuria
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-09-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the effect of the chronic treatment of type 2 diabetes (T2DM) with dapagliflozin on: (1) mitochondrial gene function/expression and insulin signaling/action and (2) oral glucose tolerance and beta cell function. Dapagliflozin is a potent, highly specific inhibitor of renal glucose transport \[SGLT2\].

Detailed description: "Glucotoxicity" has been implicated as a cause of insulin resistance and impaired beta cell function in T2DM. Abundant support for the glucotoxicity hypothesis has been provided by in vivo and in vitro studies in animals, but a rigorous test of this hypothesis in man is lacking. The investigators propose to test the glucotoxicity hypothesis by chronically reducing the plasma glucose in type 2 diabetic subjects (T2DM) with an inhibitor of renal glucose transport, dapaglifozin, and examining the effect of restoration of normoglycemia on mitochondrial function and insulin signaling/sensitivity. Lastly, the investigators will test the "glucolipotoxicity" hypothesis, which states that the toxic effects of elevated plasma FFA on insulin sensitive tissues (i.e., muscle) are magnified in the presence of concurrent hyperglycemia. Thus, high glucose levels increase malonyl CoA, which inhibits CPT I, leading to accumulation of FACoA/DAG, which impair mitochondrial function and inhibit insulin action.

Eligibility criteria: Inclusion Criteria:

* T2DM
* Drug Naive Or On Oral Therapy

Exclusion Criteria:

* Insulin Treatment
* Major Organ Disease

Primary outcomes:
measure: Change in Insulin Sensitivity
timeFrame: baseline, two weeks
Secondary outcomes:
measure: Change in Mitochondrial Function
timeFrame: baseline, two weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Diabetes Division, UTHSCSA
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Ralph DeFronzo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Devjit Tripathy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01945853: Magnetic Resonance Imaging (MRI) in Amyotrophic Lateral Sclerosis (ALS)
Official title: Imaging Myelin Injury in Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study to identify the degree of grey and white matter involvement in patients with Amyotrophic Lateral Sclerosis (ALS) utilizing non-invasive techniques. The imaging to be utilized will be the 7 Tesla (7T) magnetic resonance imaging (MRI) of the brain. These results will be correlated to the ALS Functional Rating Scale - Revised (ALSFRS-R) score to assess if any changes in MRI can be predictive in the disability of the ALS patients at baseline and at 6 month intervals. The participants will be asked to return every 6 months for a neurological examination, ALSFRS-R assessment, measurement of the vital capacity and MRI as outlined above to monitor progression of the disease.


Eligibility criteria: Inclusion Criteria:

* Males and Females who are 18 - 80 years old.
* The participants will meet the standard diagnostic criteria for possible or probable ALS (based on El Escorial criteria). They will have been diagnosed by a Johns Hopkins Neurologist.
* Healthy controls will be recruited by their interest in assisting the ALS population.

Exclusion Criteria:

* Forced vital capacity less than 60 % of predicted value.
* Documented orthopnea on ALSFRS-R or otherwise unable to lie flat in an MRI scanner for the duration of the study.
* Presence of pacemakers, aneurysm clips, shrapnel or otherwise disallowed implanted metallic devices for obtaining an MRI scan.
* Pregnant or lactating females
* Glomerular filtration rate (GFR) less than 60
* History of: encephalitis, extensive white matter disease, intracranial hemorrhage, cerebral palsy, allergy to dye and/or IV drug abuse.

Primary outcomes:
measure: MRI Changes in ALS Patients Vs Healthy Controls
timeFrame: 2 years
Secondary outcomes:
measure: MRI Changes in ALS Patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jeffrey D Rothstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: