louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02348333: Repeated Dose Phase I Study of FYU-981
Official title: Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered.


Eligibility criteria: Inclusion Criteria:

* Japanese healthy adult subjects
* Body mass index: \>=18.5 and \<25.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Primary outcomes:
measure: Pharmacokinetics (Cmax: Maximum plasma concentration)
timeFrame: 1-, 4-, and 7-day
measure: Pharmacokinetics (Cmin: Minimum plasma concentration)
timeFrame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
measure: Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
timeFrame: 1-, 4-, and 7-day
measure: Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
timeFrame: 1-, 4-, and 7-day
measure: Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
timeFrame: 1-, 4-, and 7-day
measure: Pharmacokinetics (Rauc: Accumulation ratio of AUC0-24)
timeFrame: 4-, and 7-day
measure: Pharmacokinetics (kel: Elimination rate constant)
timeFrame: 1-, 4-, and 7-day
measure: Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
timeFrame: 1-, 4-, and 7-day
measure: Pharmacokinetics (Ae: Amount of drug excreted in urine)
timeFrame: 9 days
measure: Pharmacokinetics (fe: Fraction of dose excreted in urine)
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Japan
Study officials:
References:
Clinical trial NCT00390533: An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder
Official title: An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Efficacy, Safety and Tolerability of Two Fixed Doses (100 and 30 mg Once Daily) of Saredutant in Patients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety
Keywords: Anxiety
clinical trials
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-20
Enrollment: 428
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 primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of generalized anxiety disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) Plus Generalized Anxiety Disorder module.

Exclusion Criteria:

* Total score of less than 22 on the HAM-A.
* Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 18.
* Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine Oxidase Inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.

The investigator will evaluate whether there are other reasons why a patient may not participate.

Primary outcomes:
measure: Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
timeFrame: 56 days
Secondary outcomes:
measure: Change from baseline to Day 56 of treatment in the Clinical Global Impression Severity of Illness score.
timeFrame: 56 days
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Macquarie Park
country: Australia
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT04232033: The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism
Official title: The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibroblast Growth Factor 21
Tast Perference
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: The Novo Nordisk Foundation Center for Basic Metabolic Research
First posted: 2020-01-18
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective is to evaluate taste preferences for alcohol during an intravenous infusion of the naturally occurring hormone fibroblast growth factor-21 (FGF21) and placebo (i.e. saline), respectively, in 20 healthy subjects. Secondary endpoints are to evaluate the effects of exogenous FGF21 (compared to placebo) on resting energy expenditure, preference for salt, sour and bitter taste qualities, sensations of hunger, thirst, appetite, satiety, headache and nausea, and makers of glucose metabolism (e.g. plasma/serum concentrations of glucose, C-peptide, insulin and glucagon).


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Caucasian male
* Body mass index between 19 and 27 kg/m2
* Normal haemoglobin and normal glycated haemoglobin A1c (HbA1c) (\< 42 mmol/mol)
* Weekly alcohol intake of less than 14 units of alcohol (1 unit = 12 g ethanol)

Exclusion Criteria:

* Liver diseases evaluated by plasma alanine aminotransferase (ALAT) \> 3 × normal level or an International Normalized Ratio (INR) below normal values
* Diabetes mellitus
* Nephropathy
* First-degree relatives with diabetes and/or liver diseases and/or alcohol use disorder
* Other diseases the investigator finds disruptive for participation in the study

Primary outcomes:
measure: Alcohol preference (How much do you want to drink alcohol?)
timeFrame: 1 year
Secondary outcomes:
measure: Plasma glucose concentration
timeFrame: 1 year
measure: Serum insulin concentration
timeFrame: 1 year
measure: Plasma fibroblast growth factor-21 concentration
timeFrame: 1 year
measure: Serum C-peptide concentration
timeFrame: 1 year
measure: Plasma glucagon concentration
timeFrame: 1 year
measure: Plasma lipid profile
timeFrame: 1 year
measure: Plasma insulin-like growth factor 1 concentration
timeFrame: 1 year
measure: Plasma bone marker concentration
timeFrame: 1 year
measure: Resting energy expenditure
timeFrame: 1 year
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Amalie R Lanng
Study officials:
affiliation: Center for Clinical Metabolic Research, Gentofte Hospital
name: Amalie R Lanng, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02102633: Drug Interaction Study Between Bosutinib And Dabigatran
Official title: An Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Bosutinib On The Pharmacokinetics Of Dabigatran Etexilate Mesylate Administered Orally To Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: bosutinib
dabigatran
drug interaction
p-glycoprotein
pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-03
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study evaluates the effect of a single oral dose of bosutinib on the single dose pharmacokinetics of dabigatran, a p-glycoprotein substrate, in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects between 21 to 55 years old and BMI between 17.5 and 30.5 kg/m2.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Risks of bleeding including prior personal or familiar history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder or abnormal coagulation test (PT/INR or PTT/aPTT greater than upper limit of normal) result at screening.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 48 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 48 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 48 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 48 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 48 hours
measure: Apparent Oral Clearance (CL/F)
timeFrame: 48 hours
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 48 hours
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hsyu PH, Pignataro DS, Matschke K. Effect of bosutinib on the absorption of dabigatran etexilate mesylate, a P-glycoprotein substrate, in healthy subjects. Eur J Clin Pharmacol. 2017 Jan;73(1):57-63. doi: 10.1007/s00228-016-2115-0. Epub 2016 Oct 7.
Clinical trial NCT01313533: Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
Official title: Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Atherosclerosis
Keywords: Atherosclerosis of Autologous Vein Bypass Graft
Lead sponsor: St. Luke's Hospital, Chesterfield, Missouri
Sponsor class: OTHER
First posted: 2011-03-11
Enrollment: 540
Sex: ALL
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study the effects of polyarginine treated vein grafts on graft patency for patients undergoing coronary artery bypass surgery.

Detailed description: Double blind study with Lactated Ringers Solution and Lactated Ringers Solution with Arginine soaked for 10 minutes prior to grafting on the coronary arteries.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be 25-95 years of age and able to give informed consent
2. Use of an approved statin and anti-platelet medication for at least 24 months.
3. Agreeable to Cardiovascular imaging at 12 months post-coronary artery bypass graft (CABG).
4. First time coronary artery bypass surgery,redo coronary artery bypass surgery and combined valve repair/replacement surgery and coronary artery bypass graft surgery are eligible to participate in study.

Exclusion Criteria:

1. Acute traumatic injury, vasculitis or planned concurrent ventricular surgical restoration, automatic implantable cardioverter defibrillators (AICD) placement or valvular surgery.
2. Hypercoaguable state.
3. Comorbid illness making 2 year survival unlikely.
4. Participation in another interventional investigative study of a cardiovascular drug or device within 30 days prior to CABG. May participate concurrently in other studies where the intervention/observation will not hinder execution of this study.
5. Patients with any medical condition that, in the investigator's judgment, makes the patient ineligible or places the patient at undue risk (e.g. conditions that preclude standard invasive follow up procedures such as angiography, i.e. renal failure, bleeding diathesis or peripheral vascular disease preventing catheterization via the groin).
6. Subject has clinical evidence of infection that the Investigator deems significant to the completion of the procedure or that could compromise the subject's safety.
7. Any patient was has undergone more than 20 computerized tomography (CAT) scans.
8. Any patient who is pregnant.

Primary outcomes:
measure: To study the effects of arginine on saphenous vein graft patency rates
timeFrame: 12 months post operation
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
Study officials:
affiliation: St. Luke's Hospital
name: Ronald D Leidenfrost, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03095833: Food Intake Decisions
Official title: Food Decisions and Reward System: Modulation by Olfaction and Taste
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Functional Magnetic resonance study on the effect of cognitive context variables on the perception and valuation of food odorants and flavor. The study is composed of two experiments; in a first experiment we address the question of how valuation of food odors are modulated by 3 cognitive conditions (indulgence, healthy, and neutral). Food odors are delivered using a custom-made olfactometer. Here we hypothesize that cognitive regulation can modulate the primary sensory processing of food odors. We expect that cortical regions related with valuation and cognitive regulation such as the ventromedial prefrontal cortex and the dorsolateral prefrontal cortex operate the modulation of primary olfactory cortex and amygdala. In a second experiment, we aim to reveal the brain areas involved in integrating food color cues with odor and taste stimuli. Here we hypothesize that color cues are capable of biasing flavor attributes of food (flavor intensity), and that this bias occurs at different cortical areas commonly associate with multisensory integration such as the orbitofrontal cortex, insula, amygdala and hippocampus.


Eligibility criteria: Inclusion Criteria:

* healthy or Prader-Willi
* right handed

Exclusion Criteria:

* Nursing or pregnant women
* undergoing medical treatment
* Having known olfactory disorder
* neurological or psychiatric history
* all pertinent conditions according to the use of magnetic resonance imaging.
* anosmia (partial/total)
* neurological, psychological or other disease

Primary outcomes:
measure: brain activity related to the perception of food odors and flavor
timeFrame: Hour 1
Secondary outcomes:
measure: behavioral ratings of odor/flavor valuation by participants
timeFrame: Hour 1
measure: blood alcohol level post experiment
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Bron
country: France
facility: CH le Vinatier
Study officials:
affiliation: CH le Vinatier
name: Caroline DEMILY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06224933: Augmented Reality For MRI-Guided Interventions
Official title: Augmented Reality Real-Time Guidance for MRI-Guided Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infections
Pain
Diagnosis
Image Guided Needle Biopsy
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.

Detailed description: This pilot clinical study is designed to evaluate the feasibility of using a needle guidance system during MRI-guided procedures in up to 12 patients. The MRI-compatible needle guidance system was developed under an NIH funded SBIR Phase II grant. This system has been evaluated by our Interventional Radiology team in phantom, volunteer, and cadaver studies which showed potential benefit of use in patients. Inclusion of the needle guidance system will not change the standard of care or substantively affect procedural technique as currently performed. This system provides the operator with an augmented reality (AR) display to better visualize the needle entry point and trajectory as it is inserted toward the target. This additional information could improve needle placement accuracy and shorten procedural time.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, ages 3 to 21
* Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy.

Exclusion Criteria:

* Patients who are unable to give informed consent themselves or through their parents.
* Patients under 3 years of age
* Patients over 300 pounds.
* Patients who are claustrophobic and unable to tolerate MRI-guided procedure.
* Contraindications to MRI such as MR-unsafe implants.

Primary outcomes:
measure: Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.
timeFrame: 1 day
measure: Safety of using the augmented reality needle guidance system will be evaluated through assessment of procedure related adverse events that occur within 7 days of the procedure.
timeFrame: 7 days
Secondary outcomes:
measure: Procedure time
timeFrame: 1 day
measure: Number of MRI scans
timeFrame: 1 day
measure: Clinical impressions of the system use and utility
timeFrame: 1 Day
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Karun Sharma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05532033: High Flow Nasal Cannula and Diaphragmatic Function
Official title: Effect of High Flow Nasal Cannula vs Standard Oxygen Therapy on Diaphragmatic Function After Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphragm Injury
Postoperative Complications
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 116
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: PREVENTION

Brief summary: Prospective randomized study investigating the effect of postoperative oxygen delivery on diaphragmatic function. Two different modalities of oxygen delivery will be compared: high flow nasal cannula versus standard oxygen therapy with facial mask


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective thoracic surgery

Exclusion Criteria:

* ASA score \>3
* Body mass index \> 35 kg/m2
* History of neuromuscular disease
* History of thoracic surgery
* Phrenic nerve paisy

Primary outcomes:
measure: Incidence of diaphragmatic dysfunction
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Postoperative pulmonary complication
timeFrame: 7 days after surgery
Other outcomes:
measure: Days without oxygen support
timeFrame: 7 days
Locations:
city: Ferrara
country: Italy
facility: Università di Ferrara
Study officials:
References:
Clinical trial NCT00363233: The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus
Official title: The Effects of Flax Lignans on Lipid Profile and Glucose Management in Type 2 Diabetes: a Randomized Double-Blind Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Hypercholesterolemia
Keywords: type 2 diabetes
lignans
flaxseed
cholesterol
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
First posted: 2006-08-15
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients.

Detailed description: The prevalence of type 2 diabetes is increasing dramatically in the last decade in China. Hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health outcomes. Flax lignans, a phytoestrogen found in flaxseed is thought to be the compound responsible for cholesterol-lowering effect of flaxseed. Our purpose is to improving the lipid profile in type 2 diabetic patients with supplementation of flax lignans.

Eligibility criteria: Inclusion Criteria:

* Diagnosed type 2 diabetes
* Age: 50-79 years old
* LDL-cholesterol more than 2.9 mmol/l

Exclusion Criteria:

* Current or previous (within 6 months) use of estrogen therapy
* Cancer
* Chronic gastrointestinal diseases
* Current use of antibiotics
* Any severe liver or renal diseases
* Systolic blood pressure more than 180 mmHg or phase 3 hypertension
* Any severe mental diseases
* Severe cardio- or cerebro-vascular diseases

Primary outcomes:
measure: Total cholesterol at 3 months
Secondary outcomes:
measure: LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital
state: Shanghai
Study officials:
affiliation: Institute for Nutritional Sciences, Chinese Academy of Sciences
name: Xu Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. Effects of a flaxseed-derived lignan supplement in type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS One. 2007 Nov 7;2(11):e1148. doi: 10.1371/journal.pone.0001148.