louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01119989: Effects of an Amino-acid Supplement on Hepatic Lipid Metabolism
Official title: Effects of a Supplementation With Amino-acids on Hepatic Lipid Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: hepatic fat content
hepatic de novo lipogenesis
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2010-05-10
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 10 healthy male volunteers will be studied after

* a 6 day weight maintenance, balanced diet
* a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day
* a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day and 20g amino-acids per day At the end of each 6 days period, the following measurements will be obtained
* intrahepatic lipids (1H-MRS)
* metabolic effects of fructose ingestion (measurement of substrate oxidation, gluconeogenesis from fructose, palmitate synthesis from fructose, plasma VLDL-kinetics)

This is a randomized, double blinded study


Eligibility criteria: Inclusion Criteria:

* age 18-30 years
* sex: males
* BMI between 19 and 25 kg/m2
* less than 3 30min- exercise session/week

Exclusion Criteria:

* smokers
* alcohol consumption more than 50g/week
* consumption of drugs
* history of diabetes in first degree relatives
* presence of ferro-magnetic prosthesis, cardiac pacemakers, or any contra-indication to NMR

Primary outcomes:
measure: intrahepatic lipids
timeFrame: after 6 days on each controlled diet
Secondary outcomes:
measure: 13C palmitate synthesis
timeFrame: after 6 days on each controlled diet
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: VD
Study officials:
References:
citation: Theytaz F, Noguchi Y, Egli L, Campos V, Buehler T, Hodson L, Patterson BW, Nishikata N, Kreis R, Mittendorfer B, Fielding B, Boesch C, Tappy L. Effects of supplementation with essential amino acids on intrahepatic lipid concentrations during fructose overfeeding in humans. Am J Clin Nutr. 2012 Nov;96(5):1008-16. doi: 10.3945/ajcn.112.035139. Epub 2012 Oct 3.
Clinical trial NCT01478789: Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
Official title: Naturalis Clinical Trial for a Novel Phytosterol Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products.

Detailed description: Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.

Eligibility criteria: Inclusion Criteria:

* healthy individuals aged 19-60 yr
* plasma LDL-C levels \> 3.0mmol/l
* TG \< 4.5mmol/l
* body mass index (BMI) between 20 and 30 kg/m2.

Exclusion Criteria:

* history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
* history of chronic use of alcohol (\>2 drinks/d)
* smoking
* myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months

Primary outcomes:
measure: Lipid Profile
timeFrame: Change from Baseline in lipid profile at 4 weeks (end of the phase)
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richarson Centre for Funtional Foods and Nutraceuticals
state: Manitoba
Study officials:
References:
Clinical trial NCT02990689: Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.


Eligibility criteria: Inclusion Criteria:

* Patients of any gender, aged 50 to 80 years
* Signed informed consent form
* Healthy eyes besides cataract
* Assured follow-up examinations
* Stable corneal conditions within the last 12 months
* Corneal astigmatism less than 1D
* Implantation into the capsular bag by injector

Exclusion Criteria:

* Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
* Pseudophakia
* Cornea guttata; keratoplasty
* Irregular astigmatism (e.g. Keratoconus)
* Corneal scarring
* Diabetic retinopathy
* Aniridia
* Amblyopia
* Amotio operation; anamnesis with vitreous surgery
* Pseudoexfoliation Syndrome; Uveitis
* Previous intraocular and corneal surgery
* Intraocular tumours; endotamponade
* Glaucoma or IOP higher than 24mmHg
* Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to \> 0.3 logMAR
* Need for a dioptre out of the range of +16.0D to +26.0D
* Inability to achieve secure lens placement in the capsular bag
* Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
* Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis
* Pregnancy or lactation period for female patients

Primary outcomes:
measure: Intermediate visual acuity
timeFrame: 12 months
Secondary outcomes:
measure: Distance visual acuity
timeFrame: 12 months
measure: Near visual acuity
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02408289: The Randomized Controlled Cocoa-Appetite Trial
Official title: A Pilot Randomized Human Trial on The Effects of Cocoa on Appetite.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Brooklyn College of the City University of New York
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether high-flavonoid cocoa can decrease appetite in humans. In addition the study is designed to test epicatechin, a compound found in cocoa and procyanidins, a class of compounds found in cocoa, for their ability to decrease appetite in humans.

Detailed description: The study is a four-way randomized double-blinded crossover trial with randomization balanced for beverage and lab visit order.

Eligibility criteria: Inclusion Criteria:

* stable-weight, as indicated by weight gain or loss of \<2% in the past 6 months;
* engaging in only mild exercise\< twice a week;
* moderate alcohol users, \<2 drinks/day;
* willing to eat pizza.
* mentally and physically healthy.

Exclusion Criteria:

* smokers regular;
* frequent drinkers of coffee, tea or cola sodas, \>daily;
* underweight or obese (BMI: \<18.5 or \>30 Kg/m2);
* allergies to chocolate, cocoa, green tea, coffee or pizza;
* using medication;
* interested in registering in the future for the course Health \& Nutrition Sciences 2140, Introduction to the U.S. Health Care System, that is often taught by the PI of the proposed study

Primary outcomes:
measure: Appetite as assessed by amount of pizza eaten.
timeFrame: Two and a half hours
Secondary outcomes:
measure: Appetite as assessed by a Visual Analog Scale
timeFrame: Two and one half hours
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brooklyn College of the City University of New York
state: New York
Study officials:
affiliation: Department of Health & Nutritional Sciences, Brooklyn College of the City University of New York
name: James Greenberg, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenberg JA, O'Donnell R, Shurpin M, Kordunova D. Epicatechin, procyanidins, cocoa, and appetite: a randomized controlled trial. Am J Clin Nutr. 2016 Sep;104(3):613-9. doi: 10.3945/ajcn.115.129783. Epub 2016 Aug 10.
Clinical trial NCT03487289: Comparison of NOSE and Conventional Methods in Laparoscopic Right Colon Surgery
Official title: Comparison of NOSE and Conventional Methods in Laparoscopic Right Colon Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Incision
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Laparoscopic right hemicolectomy (LRH) is an accepted surgical procedure for several right sided colonic pathologies. Recently the advantages of the intracorporeal ileotransversostomy over the extracorporeal anastomosis is appearing in the literature. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . In our daily surgical practice, investigators prefer the intracorporeal anastomosis and this study was conducted to compare the specimen extraction sites after LRH. Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LRHs.

Detailed description: compare the patient-selected NOSE method and conventional method in laparoscopic right colon cancer surgery

Eligibility criteria: Inclusion Criteria:

* laparoscopic right hemicolectomy patients

Exclusion Criteria:

* no

Primary outcomes:
measure: VAS control
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu Unıversity- general surgery
name: Ersin Gündoğan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04615689: The Association of Gut Microbiota With Urinary Tract Infection in Infants
Official title: The Association of Gut Microbiota With Urinary Tract Infection in Infants
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Urinary Tract Infections
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants hospitalized for febrile urinary tract infection. Healthy controls who visited at primary care clinic for routine check up with informed consent.

Brief summary: This prospective case-control study will compare the gut microbiota between the infants with febrile urinary tract infection and healthy infants.

Detailed description: The investigators hypothesize that the gut environment reflected by intestinal microbiota influences the risk of urinary tract infection. This prospective case-control study will compare the gut microbiota between the infants with febrile urinary tract infection and healthy infants. The investigators will sequence the V3-V4 of the bacterial 16SrRNA genes from the feces and analyze the sequencing data by QIIME2.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of febrile urinary tract infection.
* Infants

Exclusion Criteria:

* Congenital kidney disease
* Congenital heart disease
* Other metabolic disease

Primary outcomes:
measure: The differential compositional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection.
timeFrame: An average of 1 year, after the completion of recruitment.
Secondary outcomes:
measure: The differential functional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection.
timeFrame: An average of 1 year, after the completion of recruitment.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
Study officials:
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: KY YOUNG CHO, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00729989: Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation
Official title: Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation- A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Distress
Keywords: Meconium Aspiration
Respiratory Distress
Meconium Stained Amniotic Fluid
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2008-08-08
Enrollment: 173
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The stomach of the newborn baby is often emptied soon after birth to prevent breathing problems (respiratory distress). Babies born with meconium-stained amniotic fluid and those with increased secretions associated with birth by C-section are thought to be at particular risk of breathing problems during the first minutes of life. Emptying the stomach by sucking out all its contents (gastric suctioning) is alleged to lessen the risk of aspiration and improve respiratory distress. This study will evaluate the usefulness of gastric suctioning during neonatal resuscitation.


Eligibility criteria: Inclusion Criteria:

* Term infant with meconium stained amniotic fluid or born by C-section

Exclusion Criteria:

* Prematurity
* Congenital Abnormality

Primary outcomes:
measure: Respiratory Distress
timeFrame: Birth
Secondary outcomes:
measure: Apgar scores
timeFrame: Birth
measure: Successful feeding/weight gain
timeFrame: Birth
measure: Hospital length of stay
timeFrame: Birth
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Children's Hospital
state: Iowa
Study officials:
References:
Clinical trial NCT06104189: Prospective Ultrafast MRI Radiomics for Breast Cancer
Official title: Ultrafast MRI Radiomics to Classify Histological Factors and Subtypes of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Korea University Ansan Hospital
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 225
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population should fulfill the following criteria as follows:(a) histologically confirmed invasive breast cancer, (b) participant consent, and (c) MRI performed before treatment.

Brief summary: The goal of this prospective study is to investigate the performance of ultrafast MRI radiomics in classifying histological factors and subtypes of breast cancer compared with standard MRI among radiologists with varying experience. The written informed consent was obtained from all participant. We extracted 1618 radiomic features from ultrafast and standard contrast-enhanced MRI before treatment. Classification of hormonal receptors, human epidermal growth factor receptor 2, and Ki67 status and subtypes was evaluated using the area under the receiver-operating characteristic curve (AUC) with the DeLong test.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with invasive breast cancer

Exclusion Criteria:

* Diagnosed with other cancer

Primary outcomes:
measure: The signal intensity of MRI according to histological factors and subtypes of breast cancer
timeFrame: Baseline, pre-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Bo Kyoung Seo
Study officials:
affiliation: Korea University Ansan Hospital
name: Bo Kyoung Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03390829: Content and Expectations of Consultations of Patients With Opioid Substitution Treatment Considered as Stabilized: Cross-Testimonials Doctors - Patients (MSOSuiStab)
Official title: Content and Expectations of Consultations of Patients With Opioid Substitution Treatment Considered as Stabilized: Cross-Testimonials Doctors - Patients (MSOSuiStab)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Substitution Treatment
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving opiate substitution treatments considered stabilized by their GPs

Brief summary: Consultations in general medical practice concerning the follow-up of the patients receiving opiate substitution treatments are not exceptional.

It is nowadays agreed that addictive pathology goes far beyond the issue of product dependence, in favor of a pathology in itself. Centered on problems of attachment, of framework, of trust. The implementation of the opiate substitution treatments and the lifting of the product dependence appears only as a preliminary to the background work with the patient ex-user of opiate.

Finally, the literature provides little information on the experience of general practitioners and their patients under opiate substitution treatments regarding follow-up consultations in the stability phase.

The objective of this work is therefore to study the feelings on follow-up consultations, general practitioners and their patients under opiate substitution treatments considered stabilized.


Eligibility criteria: Inclusion Criteria:

* major people patients receiving opiate substitution treatments

Exclusion Criteria:

* considered unstabilized with opiate substitution treatments

Primary outcomes:
measure: assessment of feelings on follow-up consultations with standardized questionnaire
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Université Angers
Study officials:
References:
Clinical trial NCT02456129: Study in Postmenopausal Women to Investigate the Drug-drug Interaction (DDI) Between Itraconazole(ITZ) and Orally Administered Vilaprisan; Absolute Bioavailability Using Intravenous Microtracer Dose of [14C]Vilaprisan
Official title: An Open-label Study to Evaluate the Effect of Repeated Oral Administration of 200 mg Itraconazole(ITZ) Given Once Daily Over 14 Days on the Single Oral Dose Pharmacokinetics of Vilaprisan (BAY1002670) as Well as Assessment of Absolute Bioavailability Using a Single Intravenous Microtracer Dose of [14C]Vilaprisan in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Trial, Phase I
Keywords: Clinical Trial, Phase I
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-05-28
Enrollment: 14
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a study in postmenopausal women to investigate the Drug-drug interaction (DDI) between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using intravenous microtracer dose of \[14C\]vilaprisan.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI): 18 ≤ BMI ≤ 32 kg/m²
* Postmenopausal state revealed by:

Medical history, if applicable (natural menopause at least 12 months prior to first study drug administration; or surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration), in addition: in women \< 65 years old, follicle stimulating hormone (FSH) \> 40 IU/L

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
* Known or suspected liver diseases
* Clinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination)

Primary outcomes:
measure: Area under the concentration time curve [AUC(0-11d)] after single oral dose of vilaprisan with and without ITZ.
timeFrame: up to 14 days
measure: Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ.
timeFrame: up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
state: West Yorkshire
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Schultze-Mosgau MH, Hochel J, Prien O, Zimmermann T, Brooks A, Bush J, Rottmann A. Characterization of the Pharmacokinetics of Vilaprisan: Bioavailability, Excretion, Biotransformation, and Drug-Drug Interaction Potential. Clin Pharmacokinet. 2018 Aug;57(8):1001-1015. doi: 10.1007/s40262-017-0607-4.