louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02614352: Investigate a Pharmacokinetic Characteristics and the Safety of AG1502 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2015-11-25
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and Atorvastatin 40mg in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Adult healthy males 19 to 45 years at screening.
* BMI 18-29 kg/m2

Exclusion Criteria:

* History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease
* Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin
* Hypotension (DBP ≤ 100 mmHg or SBP ≤ 95mmHg) and hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
* Gastrointestinal disease affected the absorption of medications
* Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
* AST or ALT \> 2 x normal range
* Total bilirubin \> 2.0 mg/dl
* CK \> 2 x normal range
* eGFR \< 60 mL/min/1.73m2
* Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study
* Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study
* Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
* Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
* Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin
* Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days
* History of drug abuse
* Genetic neuromuscular disorder or family history of neuromuscular disorder
* Unusual diet affected the absorption, distribution, metabolism, excretion of medications
* Subjects deemed ineligible by investigator based on other reasons

Primary outcomes:
measure: Cmax (candesartan cilexetil)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours
measure: AUClast (candesartan cilexetil)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours
measure: Cmax (Atorvastatin)
timeFrame: 0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours
measure: AUClast (Atorvastatin)
timeFrame: 0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06457152: Multi-Center Project: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure
Official title: Multi-Center Project: BETTER CARE - HF (Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: University of Pennsylvania
name: OhioHealth
First posted: 2024-06-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test an automated, electronic health record (EHR-)embedded alert to improve prescribing of guideline-directed medical therapy for patients with heart failure and reduced ejection fraction (HFrEF). The investigators have previously tested and implemented this alert at NYU Langone Health (NYULH), and will now test and implement this alert across three other health systems.


Eligibility criteria: Inclusion Criteria:

* Patient with an encounter visit at participating cardiology practice during the study period
* Patient with EF of less than or equal to 40% on most recent echocardiogram at the time of visit
* Patient ages 18-90

Exclusion Criteria:

* Pregnancy
* Ventricular assist device
* Hospice
* Cardiac amyloid
* Medication-specific exclusion for MRA: most recent systolic blood pressure less than 105 mm Hg, most recent potassium \< 5.1, any potassium \> 5.5, most recent glomerular filtration rate \< 30 (using MDRD equation), or a documented MRA allergy.

Primary outcomes:
measure: Number of Patients with a Prescription for Mineralocorticoid Antagonists (MRA)
timeFrame: Up to Day 30
Secondary outcomes:
measure: Number of Patients with a Prescription for Beta-Blocker (BB)
timeFrame: Up to Day 30
measure: Number of Patients with a Prescription for ACE-I/ARB/ARNI
timeFrame: Up to Month 36
measure: Number of Patients with a Prescription for Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i)
timeFrame: Up to Month 36
measure: Number of Patients with Hyperkalemia
timeFrame: Up to Month 36
measure: Number of Patients who are Hospitalized
timeFrame: Up to Month 36
measure: Number of Patients who are Hospitalized for Heart Failure (HF)
timeFrame: Up to Month 36
Other outcomes:
Locations:
city: Boston
country: United States
facility: University of Massachusetts
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: NYU Langone Health
name: Amrita Mukhopadhyay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00643552: Muscle Strength, Physical Work Capacity and Functional Performance in Individuals With Down Syndrome
Official title: Muscle Strength, Physical Work Capacity and Functional Performance in Individuals With Down Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Keywords: Muscle Strength
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 18
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: This project will evaluate muscle strength and its relationship to everyday function in individuals with Down Syndrome.


Eligibility criteria: Inclusion Criteria:

* Down Syndrome
* Mild or moderate mental retardation
* Able to tolerate exercise testing

Exclusion Criteria:

* Uncontrolled cardiovascular disease
* orthopedic limitations to exercise

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02774252: 18475 - Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-05-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04921852: The Comparation of Lateral Sagittal Infraclavicular and Costoclavicular Block
Official title: The Comparation of Lateral Sagittal Infraclavicular and Costoclavicular Approach in Brachial Plexus Blocks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Extremity Problem
Keywords: costoclavicular block
Lateral sagittal Infraclavicular block
brachial plexus block
block onset time
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, the investigators aimed to compare the block dynamics and characteristics of the two approaches while providing effective analgesia and safe anesthesia of the Ultrasound-guided Lateral sagittal Infraclavicular and costoclavicular approach in Brachial plexus blocks.

Detailed description: Participants between the ages of 18-70 with the American Society of Anesthesiology (ASA) score I-II-III will be included in the study. All participants will be evaluated preoperatively and information will be given about the anesthetic method to be applied. Demographic data and ASA scores of the participants will be recorded.

All of the participants included in the study will be taken to the regional anesthesia application room in the operating room approximately 1 hour before the operation. After standard anesthesia monitoring (electrocardiography, pulsoximetry, non-invasive blood pressure), all participants will be given an iv vascular access with a 20 or 22 G cannula from the arm that will not be operated.

All blocks will be made using portable US machine and echogenic block needle.

For all blocks, 20 ml of a mixture of 0.25% bupivacaine, 1% lidocaine will be used.

An overall (average) sensory and motor score was also calculated for every participants and at each time point assessed by averaging the VRS sensory or motor scores of all the 4 nerves will be tested preoperatively.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status 1 to 3
* 18-70 age
* hand , wrist , forearm and elbow surgery

Exclusion Criteria:

* refusal to participate,
* pregnancy,
* body mass index of 30 kg/m2 or greater
* history of allergy to local anesthetic drugs
* prior surgery over the infraclavicular fossa,
* preexisting neurological deficit
* coagulopathy
* infection over infraclavicular fossa.

Primary outcomes:
measure: readiness for surgery time
timeFrame: 30 minute
Secondary outcomes:
measure: block performance time
timeFrame: 5 minute
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00067652: Improving Body Image in Middle Schoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Body Image
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-08-27
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The focus of this study is the development of a school-based multimedia product for the prevention of body dissatisfaction and unhealthy weight control behaviors in adolescents. The program is being designed for early adolescents, age 12-14, and will include information on maturation, healthy eating and exercise, skill building modules and media literacy awareness.


Eligibility criteria: Adolescents will be recruited from participating schools. Participants must be between the ages of 11-14 years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newton
country: United States
facility: Inflexxion, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT01258452: Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects
Official title: Randomized, Balanced, Single Dose, Cross-Over Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: CERESPIR
Sponsor class: INDUSTRY
First posted: 2010-12-13
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption of CHF 5074 after single oral administration in young healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.
* Subject has a body mass index between 18 and 30 kg/m\^2, inclusive.

Exclusion Criteria:

* Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
* Abnormal result of liver function tests, renal function tests or thyroid tests performed at screening.
* Significant allergic conditions that require medical treatment
* Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
* Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.

Primary outcomes:
measure: area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96)
timeFrame: from Day 1 to Day 5
measure: peak CHF 5074 plasma concentration (Cmax)
timeFrame: from Day 1 to Day 5
Secondary outcomes:
measure: the time of occurrence of Cmax (Tmax)
timeFrame: from Day 1 to Day 5
Other outcomes:
Locations:
city: Eatontown
country: United States
facility: Iberica Clinical Research Center
state: New Jersey
Study officials:
affiliation: Iberica Clinical Research Center
name: Magdy L. Shenouda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04366752: Thrombo Embolic Events in Critical Care Patients With Covid-19 Serious Acute Pneumopathy
Official title: Thrombo Embolic Events in Critical Care Patients With Covid-19 Serious Acute Pneumopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Pneumonia
ARDS
Hemostasis
Coagulation
Keywords: COVID-19
pneumonia
ARDS
venous ultrasound
hemostasis
coagulation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: every patient hospitalized in CHU Amiens medical ICU with pneumonia due to COVID-19 infection

Brief summary: The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of pro-inflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation-induced thrombosis.

Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. Very few data are available regarding the biological disorders of coagulation in these patients. Th purpose of this project is to analyze hemostasis and coagulation of patients with infection of COVID-19 and severe pneumonia.


Eligibility criteria: Inclusion Criteria:

* patients hospitalized in medical ICU with pneumonia due to COVID-19 infection

Exclusion Criteria:

* patients\< 18 years

Primary outcomes:
measure: Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU.
timeFrame: up to 6 weeks
measure: Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
timeFrame: up to 6 weeks
measure: Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
timeFrame: up to 6 weeks
measure: Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT04565652: ICD Shock Detection by a Wearable
Official title: Clinical Evaluation of the LOIS Smartband in Patients Undergoing Elective ICD Implantation With Defibrillation (DFT) Threshold Testing.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Heart Arrest
Cardiopulmonary Arrest
Keywords: ICD
Defibrillator
Lead sponsor: Lois Medical LTD
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group of patients will wear the LOIS ICD smartband during elective ICD defibrillation
Primary purpose: SUPPORTIVE_CARE

Brief summary: Trial to assess the ability of a wearable to detect defibrillation from an implantable ICD

Detailed description: Non-invasive, pain-free clinical evaluation of a wearable/proximity sensor designed to detect a high voltage therapeutic shock received by a patient from their Implantable Cardioverter Defibrillator (ICD) during defibrillation threshold testing (DFT), which is a routine part of the clinical procedure.

Eligibility criteria: Inclusion Criteria:

* Capable of understanding procedure and making informed consent
* Listed for elective ICD Implant
* Having routine DFT as part of elective ICD implantation

Exclusion Criteria:

* Not indicated for ICD implant
* Incapable of making informed consent
* Pregnant
* Not on stabilised anti-coagulation

Primary outcomes:
measure: Sensitivity of investigational device at detecting ICD shocks
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References:
Clinical trial NCT05704452: Validity and Reliability of the GPCOG -TR
Official title: Validity and Reliability of the Turkish Version of General Practitioner Assessment of Cognition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia
Keywords: General Practitioners
Early diagnosis
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 230
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The participants of this study were members of the Neurology Department of Maltepe University Medical Faculty Hospital.

Brief summary: The General Practitioner assessment of Cognition (GPCOG) was specifically developed as a brief cognitive screening tool to be used by general practitioners (GPs). It consists of a patient section testing cognition and an informant section asking historical questions. The aim of this study was to test the validity and reliability of the Turkish version of GPCOG-TR on Turkish older adults.


Eligibility criteria: Inclusion Criteria:

* Age: least 55 years old
* Provide informed consent
* Diagnosed with dementia ( patient group)

Exclusion Criteria:

* Living in a nursing home
* Presence of psychiatric disorders requiring treatment
* Presence of other comorbidity interfering with cognitive performance such as severe chronic heart failure, chronic obstructive pulmonary disease, diabetes, anemia Impairment of auditory or visual perception
* Low education
* Known cognitive impairment (for control group only)
* Lack of a reliable informant.

Primary outcomes:
measure: The Clinical Dementia Rating score (CDR)
timeFrame: 1-2 hrs
measure: the General Practitioner Cognitive Assessment tool (GPCOG-TR)
timeFrame: 10 min
Secondary outcomes:
measure: The Mini-mental State Examination (MMSE)
timeFrame: 10 min
measure: Alzheimer's Disease Assessment Scale-Cognitive scale (ADAS-Cog)
timeFrame: 30 min
measure: Geriatric Depression Scale (GDS)
timeFrame: 5 min
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
state: Ataşehir
Study officials:
References: