louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05794620: Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings
Official title: Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings: FAMILY
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Autism Spectrum Disorder
Autism
Lead sponsor: East Suffolk and North Essex NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Quadram Institute Bioscience
First posted: 2023-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with ASD

Brief summary: This study aims to accurately characterise the gut microbiota composition of faeces of children with ASD and compare it with the gut microbiota composition of their neurotypical siblings. In addition it aims to also characterise the metagenome and metabolome of the faeces of both ASD and neurotypical siblings.


Eligibility criteria: Inclusion Criteria:

* Children of both sexes who are diagnosed with ASD and under the care of ESNEFT who have a neurotypical sibling (either full or half sibling), who share their living environment. This is due to the study requiring stool samples that are from siblings, to control for genes and environment where possible.
* Aged 3 years to 10 years old (at time of consent)
* Parent/guardian able to consent to participate
* Parent/guardian able to complete required surveys (or with accommodated adjustments)

Exclusion Criteria:

* Use of antibiotics in the previous 4 weeks
* Not under the care of ESNEFT
* Children \<3 years old and \>10 years old
* Children that don't have half or full siblings
* Parent/guardian unable to provide informed consent or complete surveys, despite reasonable adjustments being implemented

Primary outcomes:
measure: Gut microbiota
timeFrame: 0 weeks
Secondary outcomes:
Other outcomes:
measure: Gut microbiota
timeFrame: 6 weeks
Locations:
city: Colchester
country: United Kingdom
facility: East Suffolk and North Essex Nhs Foundation Trust
Study officials:
affiliation: East Suffolk and North Essex NHS Foundation Trust
name: Ben Marlow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06236620: Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat
Official title: Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zinc Absorption
Keywords: zinc absorption
zinc bio-availability
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this project is to investigate whether the increased zinc bio-accessibility values in sprouted or hydrothermally processed wheat is reflected in an increased zinc absorption in human subjects after consuming breakfast flakes derived from such processed wheats.

Detailed description: The zinc study is a randomised crossover design with two different meals (control wheat flakes and flakes derived from sprouted wheat or flakes derived from hydrothermally processed wheat) spiked with a specific zinc isotope. The study contains two test groups (I and II) of 26 and 10 participants, respectively. Both test groups will consume the control wheat flakes, whereas test group I will consume the flakes from sprouted wheat and group II the flakes from hydrothermally processed wheat randomised over two test days. An intravenous dose of Zn will be given on day 1 of the study and the zinc isotope composition in the urine of the participants will be measured on day 1,5,6,7 and 8 of the study.

Eligibility criteria: Inclusion Criteria:

* BMI range 18.5-25.0 kg/m²
* Regular diet with 3 meals a day (at least 5 times a week)

Exclusion Criteria:

* Intake of vitamin and/or mineral supplements during and 2 weeks before the stud
* Intake of antibiotics 3 months prior to the study
* Intake of medicines that have an impact on the gastrointestinal tract during and 2 weeks before the study
* Previous or current gastrointestinal (e.g. Crohn's disease), endocrine or eating disorders or other gastrointestinal history
* Previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
* Currently smoking (have smoked in the last 28 days) or willingness to smoke during the study period
* Pregnant or lactating or wishing to become pregnant in the period of the study
* Allergy or intolerance to wheat (coeliac disease, gluten sensitivity) or citric acid
* Adherence to vegan or vegetarian diets or special diets (weight loss, gluten-free etc...)
* Blood donation in the 6 months prior to the study

Primary outcomes:
measure: Zinc absorption
timeFrame: day 1 (before test meal) and day 5,6,7 and 8
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven/UZ Leuven
Study officials:
affiliation: KU Leuven
name: Kristin Verbeke, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02912520: Comparison of IgA Levels in the Bronchoalveolar Lavage Fluid of Patients With and Without Antibiotic Therapy
Official title: Comparison of IgA Levels in the Bronchoalveolar Lavage Fluid of Patients With and Without Antibiotic Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunoglobulin A
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive inclusion of eligible patients admitted to the ICU.

Brief summary: Investigators hypothesize that Immunoglobine (Ig) production is influenced by the microbiota of the gut. Investigators will compare microbiota-dependent Ig production in the bronchoalveolar lavage fluid of patients with and without antibiotic therapy in order to detect significant differences.


Eligibility criteria: Inclusion Criteria:

* endotracheal intubation
* antibiotic therapy for 2 weeks OR no antibiotic therapy for at least 3 months

Exclusion Criteria:

* active infection
* pregnancy
* immunodeficiency

Primary outcomes:
measure: IgA levels in the bronchoalveolar lavage fluid
timeFrame: 2 weeks of ICU stay
Secondary outcomes:
measure: number of detected bacterial, viral, and fungal infections per patient
timeFrame: through study completion, an average of 2 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Oliver Robak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoogkamp-Korstanje JA, de Koning J, Heesemann J, Festen JJ, Houtman PM, van Oyen PL. Influence of antibiotics on IgA and IgG response and persistence of Yersinia enterocolitica in patients with Yersinia-associated spondylarthropathy. Infection. 1992 Mar-Apr;20(2):53-7. doi: 10.1007/BF01711062.
Clinical trial NCT00204620: Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)
Official title: Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma, Soft Tissue
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Arbeitsgemeinschaft fur Internistische Onkologie
name: German Sarcoma Group
First posted: 2005-09-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aims of this trial are to evaluate the efficacy of bendamustin in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-baesd chemotherapy and to assess the treatment of toxicity.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic or non-resectable soft tissue sarcoma
* Evidence of progression or relapse after an anthracycline-based and/ or ifosfamide-based chemotherapy
* At least 1 bidimensionally measurable tumor lesion according to RECIST criteria
* No previous radiation therapy on the only measurable lesion
* Willingness to receive regular follow-up
* Life expectancy more than 3 months
* ECOG status \>= 2
* Patients aged 18 years and beyond
* leucocytes \> 2500/µl, thrombocytes \> 75000/µl)
* Serum creatine \< 1,5 times the upper limit of normal value, GFR \> 60/ml
* Written patient informed consent
* Ability to give informed consent

Exclusion Criteria:

* Previous or concurrent radiation of the index lesion (radiation of single lesion is allowed if not the index lesion)
* Insufficient liver function (bilirubin \> 1.5 the upper limit of normal, prolongation of PT and aPTT \> 1.5 the upper limit of normal; ASAT and ALAT \> 3 the upper limit of normal (patients with liver metastases ASAT and ALAT \> 5 the upper limit of normal)
* Active infection
* Prior therapy with Bendamustin hydrochloride
* Prior malignancies (other than adequately treated carcinoma in situ (CIS) of the cervix, bladder urothelium, basal cell carcinoma or adenoma of the colon including pTIS,pTIN), unless treated with curative intent and without evidence of disease \> 5 years
* Symptomatic cardio- and/or cerebrovascular disease (NYHA-Scale III°)
* Interval since last chemotherapy \< 4 weeks
* Evidence of CNS-metastases
* Evidence of pregnancy or lactation
* Woman of child-bearing potential without reliable methods of birth control

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Medical center II, University of Tuebingen
Study officials:
affiliation: South West German Cancer Center, Medical Center II, University of Tuebingen
name: Joerg T Hartmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01548820: Resistance to Lamivudine in HBV Egyptian Patients
Official title: Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B Virus Treatment
Keywords: Hepatitis B virus
Lamivudine
Resistance to treatment
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology \& Tropical Medicine Research Institute in Egypt in the period from 2007- 2011.

Brief summary: On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

Detailed description: Primarily: To study the correlations between the following parameters in adult Egyptian patients with chronic viral hepatitis B before treatment:

* ALT.
* HBeAg.
* HBV-DNA by quantitative PCR.
* Biopsy (if possible). Secondarily: After receiving lamivudine therapy we will identify the impact of these parameters on viral breakthrough at 1 year of therapy.

Eligibility criteria: Inclusion Criteria:

* Adult patients \>18 years old
* Egyptian nationality
* Positive serology for HBsAg for more than 6 months
* Positive HBV viremia (above 2000IU/ml).
* Lamivudine monotherapy

Exclusion Criteria:

* Anti-HBcIgM seropositivity
* Positive serology for HCV
* Positive serology for HDV
* Patients complicated with HCC

Primary outcomes:
measure: Resistance to Lamivudine Therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tropical medicine department
Study officials:
References:
Clinical trial NCT04967820: Burn-out Among Chinese Anaesthesiologist After COVID-19 Pandemic Peak and Its Protective Factor： a National Survey
Official title: Burn-out Among Chinese Anaesthesiologist After COVID-19 Pandemic Peak and Its Protective Factor: a National Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Society of Anesthesiology
First posted: 2021-07-20
Enrollment: 6631
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: working anaesthesiologist in mainland China

Brief summary: The investigators proposed a national representative survey to collect data of socio-demographic characteristics, level of exposure to COVID-19, depression，anxiety， ptsd， burnout and resilience of working anaesthesiologists across mainland China for the following purpose

1. Explore the current burn-out rate of Chinese anaesthesiologists and compared it with data acquired in 2015；
2. Explore the perceived covid-19 exposure of COVID-19 among Chinese anaesthesiologist.
3. Explore rate of burnout, anxiety, depression, PTSD symptoms experienced by the participants
4. Explore the protective psychosocial characteristics of burnout. (resilience)
5. See whether covid-19 exposure contribute to higher burn out rate.


Eligibility criteria: Inclusion Criteria:

working anaesthesiologist in mainland China

Exclusion Criteria:

-

Primary outcomes:
measure: Burnout
timeFrame: data will be retrieved and recored 1 week after survey distribution
Secondary outcomes:
Other outcomes:
measure: Post-Traumatic Stress Disorder
timeFrame: data will be retrieved and recored 1 week after survey distribution
measure: Resilience
timeFrame: data will be retrieved and recored 1 week after survey distribution
measure: Depressive symptoms
timeFrame: data will be retrieved and recored 1 week after survey distribution
measure: Anxiety
timeFrame: data will be retrieved and recored 1 week after survey distribution
Locations:
city: Peking
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT00477620: Study of Myopia Acquisition and Prevention
Official title: Study of Myopia Acquisition and Prevention in a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Myopia
Prevention
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2007-05-24
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose:

To determine whether the use of reading glasses blocks the near work mediated increased incidence of myopia in healthy school children.

Methods:

SMART enrolled 115 emmetropic children (ages 7-9 years). The children were recruited in the Principality of Liechtenstein. They were randomly assigned to either the control group (n=52) or to receive reading glasses with a lens power of +2.0 dioptres (n=63). The primary outcome measure was progression towards myopia as determined by autorefraction after cycloplegia. The secondary outcome measure was change in biometry measurements of corneal curvature, axial length, anterior chamber depth, crystalline lens thickness, and vitreous chamber depth using partial coherence interferometry.


Eligibility criteria: Inclusion Criteria:

* Emmetropia

Exclusion Criteria:

* Ametropia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Augenwerk Liechtenstein
name: Alexaner Reis, PD Dr. med.
role: STUDY_CHAIR
References:
Clinical trial NCT03072420: Characterization of Fingertips Using MRI Images (FINGERS-COMPRESSION)
Official title: Characterization of Fingertips Using MRI Images : Development of Mechanically Faithful Models Dedicated to Manipulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: MRI, fingers compression
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objectives was to obtain MRI images of the index finger of the subjects without loading and with loadings (normal and shear forces from 1 to 4N).


Eligibility criteria: Inclusion Criteria:

* Active voluntary healthy adult aged 18 to 65, affiliated to a social security scheme
* Stature between 170 and 179cm
* Body mass index (BMI) between 20 and 25
* No previous hand musculoskeletal disorders
* Cognitive level compatible with oral communication, adherence to instructions and understanding of gestures
* Having signed the consent to participate in the study

Exclusion Criteria:

* the subject presents a neurological or orthopedic disorder ;
* the subject presents a pathology that could disturb the task ;
* the subject has an Magnetic Resonance Imaging (MRI) contraindication (wears a pacemaker, insulin pump, prothesis, etc, has claustrophobia, ...)

Primary outcomes:
measure: Average fingertip deflection under compression
timeFrame: Day 1
Secondary outcomes:
measure: Average fingertip dimensions
timeFrame: Day 1
Other outcomes:
Locations:
city: Bron
country: France
facility: IFSTTAR
Study officials:
affiliation: IFSTTAR
name: Georges BARATON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018720: Regulation of Sterol Homeostasis
Official title: Regulation of Sterol Homeostasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertriglyceridemia
Keywords: triglyceride
bile acids
cholelithias
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine how people with high triglycerides metabolize and absorb bile acids, compounds made in the body from cholesterol.

This project has two objectives: A) To define the mechanism of impaired bile acid absorption in hypertriglyceridemia (specifically we will determine if the active or passive component of absorption is abnormal) and B) to determine the contribution of an alternative pathway of bile acid synthesis which begins with 27-hydroxylation of cholesterol. Because 27-hydroxylase is present in endothelial cells as well as liver, this pathway may play a role in removal of cholesterol from incipient atherosclerotic plaque.


Eligibility criteria: Hypertriglyceridemia and normal controls with normal lipids

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: VA Medical Center
state: Minnesota
Study officials:
name: Norman Javitt, M.D.
name: Alan Hofmann, M.D.
name: Loren Zech, M.D.
References:
Clinical trial NCT02384720: Study of Freefol-MCT PKPD in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Adults over 20years old

Brief summary: The purpose of this study is to analysis PKPD of Freefol-MCT and to investigate relationship between the concentration of Freefol-MCT and the index which signaly analyzes those: EEG, EEG approximate entropy, systolic BP, saturation wave form and invasive BP wave form.


Eligibility criteria: Inclusion Criteria:

* Adults males/Females aged over 20years
* Health screening examination within 60 days of the start (Interview, vital signs , 12-lead ECG, blood tests, urinalysis) .
* The applicant who agreed in writing by told an explanation enough about the characteristics of the study drug, the purpose of the test and the details.

Exclusion Criteria:

* Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.)
* Who had acute disease or organ dysfunction within four weeks of the start of the test.
* Who had significant hematologic disorders or donate whole blood within two months of the start of the test.
* Significant neuropsychiatric or more.
* Continued drug abuse.
* Who has a history of drug and other hypersensitivity reactions.
* Positive at Type B / C hepatitis , syphilis tests (VDRL), if in AIDS antibody test
* Who took other clinical medicine within two months of the start of the test.
* Who smokes or drinks within two weeks after dosing.
* Who takes drugs regularly other than the mineral claim or vitamin. However, it depends on judgment of the researchers.

Primary outcomes:
measure: Non- compartment pharmacokinetic parameters
timeFrame: 1200 minutes
measure: Compartment pharmacokinetic parameters
timeFrame: 1200 minutes
measure: BIS
timeFrame: 1200 minutes
measure: SBP
timeFrame: 1200 minutes
measure: E0
timeFrame: 1200 minutes
measure: Emax
timeFrame: 1200 minutes
measure: Ce50
timeFrame: 1200 minutes
measure: ke0
timeFrame: 1200 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00371020: The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Proliferative Vitreoretinopathy
Keywords: silicone oil
PVR
retinal redetachment
low molecular weight heparin
5-FU
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-01
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of combined 5-FU and low molecular weight heparin in infusion on the rate of retinal redetachment after silicone oil removal in cases of proliferative vitreoretinopathy (PVR).


Eligibility criteria: Inclusion Criteria:

* Cases with history of vitrectomy and silicone oil injection for management of PVR who undergo silicone oil removal

Exclusion Criteria:

* any sign of retinal redetachment before silicone oil removal
* any sign of diabetic retinopathy

Primary outcomes:
measure: Retinal redetachment rate
Secondary outcomes:
measure: visual acuity
measure: intraocular pressure
measure: reoperation
measure: relative afferent pupillary defect
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamid Ahmadieh, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Hamid Ahmadieh, MD
role: PRINCIPAL_INVESTIGATOR
References: