louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02710513: ProAliFun_6.5_Health Effects of a Functional Pasta Enriched With Barley Beta-glucans on Healthy Subjects
Official title: Technological and Clinical Innovative Protocols for the Production of Functional Foods - 6.5 (ProAliFun65)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: beta-glucans
gut microbiota
p-cresyl sulphate (pCS)
indoxyl sulphate (IS)
short-chain fatty acid (SCFA)
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
Collaborators: name: University of Bari
First posted: 2016-03-16
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the healthy properties of a dietary intervention based on an innovative pasta enriched with prebiotic fibers (barley beta-glucans).

The hypothesis is that the gut microbiota and metabolome, the nutritional status, the redox/subclinical inflammation parameters and the markers of cardiovascular risk may improve in healthy subjects.

Detailed description: This clinical trial is a prospective pilot study, lasting 4 months. A target number of 30 healthy individuals meeting inclusion and exclusion criteria, assessed at enrollment, and which have signed the informed consent, will be recruited.

Eligibility criteria: Inclusion Criteria:

* healthy subjects
* aged between 30 and 70 years
* BMI between 18.5 and 24.9
* omnivorous diet
* informed consent signed

Exclusion Criteria:

* diabetes type 2
* urine protein \> 1g/24h
* antibiotics and probiotics administration by 15 days before the enrollment
* gastrointestinal, celiac, inflammatory systemic and chronic liver diseases
* recent diagnosis of cancer
* corticosteroid or immunosuppressive therapies
* previous major acute cardiovascular pathologies (heart attack, cerebral ictus)
* hyperlipidemia
* consume of alcohol
* psychiatric diseases

Primary outcomes:
measure: Reduction in non-HDL cholesterol
timeFrame: at the end of the intervention period (2 months)
Secondary outcomes:
measure: Effects on gut microbiota SCFA modulation
timeFrame: at the end of the intervention period (2 months)
measure: Effects on gut microbiota pCS modulation
timeFrame: at the end of the intervention period (2 months)
measure: Effects on gut microbiota IS modulation
timeFrame: at the end of the intervention period (2 months)
measure: Effects on Flow-mediated dilation (FMD)
timeFrame: at the end of the intervention period (2 months)
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AOUC "Policlinico"
Study officials:
affiliation: Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico"
name: Loreto Gesualdo, MD Full Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00981513: Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
Official title: Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza Virus Infection
Influenza-like Illness
Acute Respiratory Infection
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 6300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the degree of indirect benefits to family members and classmates resulting from administration of influenza vaccine to children.


Eligibility criteria: Inclusion Criteria:

* Hong Kong residents aged between 7 and 11 and their family members.

Exclusion Criteria:

* Children with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.
* Children receiving aspirin therapy or aspirin-containing therapy.
* Children with asthma or active wheezing.
* Children or family members with underlying immunocompromised condition or receiving immunosuppressive agents.

Primary outcomes:
measure: Clinical influenza by self-reported symptoms, specifically defined as at least two of fever ≥37.8ºC, cough, headache, sore throat, aches or pains in muscles or joints
timeFrame: One year
measure: Influenza virus infection confirmed by RT-PCR
timeFrame: One year
Secondary outcomes:
measure: Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology.
timeFrame: One year
measure: Adverse events following vaccination
timeFrame: 7 days
Other outcomes:
Locations:
city: Pokfulam
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Benjamin J Cowling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05762913: Effect of the Diaphragm Release Technique on Sleep Duration and Quality
Official title: Effect of the Diaphragm Release Technique on Sleep Duration and Quality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diaphragm; Relaxation
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Even in healthy individuals, there may be tensions in the diaphragm muscle due to factors such as wrong posture, wrong breathing pattern, sedentary lifestyle, and it cannot fully fulfill its function. As a result of this tension in the diaphragm muscle, the breathing pattern deteriorates and sleep quality decreases. The aim of this study is to examine the effect of diaphragm release technique on sleep duration and sleep quality in healthy individuals. In this study, sleep quality of individuals will be evaluated with Pittsburgh Sleep Quality Index (PUKI), sleep duration, heart rate and step count with Fitbit® Inspire 2. 32 individuals living in Tokat will be included in the study. After obtaining the sociodemographic information of the individuals, the average of sleep duration, heart rate and step counts will be recorded for 3 days with the Fitbit® Inspire 2 wearable technology to be provided within the scope of the project. Sleep quality will be recorded with PUKI. The diaphragm release technique will be applied in 3 sessions, with 2 days of rest in between. After the applications are finished, sleep time, heart rate and step counts will be recorded for 3 days with Fitbit® Inspire 2 wearable technology.


Eligibility criteria: Inclusion Criteria:

* Individuals between the ages of 18-65 who do not have any chronic disease or any past or present psychological disorder will be included.

Exclusion Criteria:

* Individuals with any neurological, psychiatric or cognitive impairment will be excluded from the study.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: 3rd day
measure: Sleep Time
timeFrame: 3rd day
measure: Heart Rate
timeFrame: 3rd day
measure: Step Count
timeFrame: 3rd day
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Study officials:
References:
Clinical trial NCT01597713: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
Official title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-05-14
Enrollment: 83
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers.

The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.


Eligibility criteria: Inclusion Criteria:

* Body mass index 18-28 kg/m\^2 (both inclusive)
* Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as randomised
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator
* Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Primary outcomes:
measure: Number of adverse events
timeFrame: Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit
Secondary outcomes:
measure: Area under the serum insulin concentration-time curve (with Trial part 1)
timeFrame: From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively
measure: Area under the glucose infusion rate (GIR)-time curve (Trial part 1)
timeFrame: From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively
measure: Area under the serum insulin concentration-time curve (Trial part 2)
timeFrame: From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01565213: Transdiagnostic Group Treatments for Patients With Common Mental Disorders in Primary Health Care
Official title: Transdiagnostic Group Treatments for Patients With Common Mental Disorders in Primary Health Care: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorders
Depressive Disorders
Stress Disorders
Keywords: primary health care,common mental disorders,
group therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of CBT and MMI on the quality of life and relief of psychological symptoms of patients with common mental disorders or problems attending primary health care centre.

Detailed description: Design:

Clinical randomised non blinded controlled trial.

Setting:

The study was performed in an outpatient primary health care centre serving 36 000 inhabitants.

Participants:

Patients (n=278), aged 18-65 years, with common mental problems or disorders were referred to the study by the GPs and 245 were included in the study.

Interventions:

Participants were randomised to CAU or one of two group interventions in addition to CAU. These were: a) group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks, and b) group multimodal intervention (MMI) based on a protocol comprising a mix of existing group interventions and exercises borrowed from multiple techniques and therapeutic schools and administered by assistant nurses with brief training, including two sessions per week for 6 weeks.

Main outcome measures:

Primary outcome measure was the Mental Component Summary score of SF-36. Secondary outcome measures were perceived stress scale (PSS) and Self-Rating Scale for Affective Syndromes (CPRS-S-A)

Eligibility criteria: Inclusion Criteria:

* patients with common mental disorders or problems

Exclusion Criteria:

patients were excluded if:

* they met diagnostic criteria for bipolar or psychotic disorder or severe personality disorder,
* were judged to be at risk of committing suicidal acts, and
* if they had undergone MMI earlier. The investigators paid no consideration to whether patients were treated with SSRI medication.

Primary outcomes:
measure: Change in Quality of life as measured by the SF-36 (Mental Component Score)
timeFrame: Change from baseline in SF-36 at 52 weeks
Secondary outcomes:
measure: Change in Psychopathology as measured by the Comprehensive Psychopathological Rating Scale Self-asssessmen (CPRS-S-A)
timeFrame: Change from baseline in CPRS-S-A at weeks 52
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Center for Family and Community Medicine, Karolinska Institutet,
Study officials:
References:
Clinical trial NCT00639613: The Role of Small Intestinal Endocrine Cells in Type 2 Diabetic Hyperglucagonemia
Official title: Exspression of Prohormone Convertase 1 and 2 in Small Intestinal Endocrine Mucosa Cells in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes

Brief summary: The purpose of this study is to determine whether excessive secretion of glucagon in type 2 diabetes originates from the pancreatic alpha-cells or endocrine cells in the mucosa of the small intestinal.

Detailed description: Hyperglucagonemia contributes significantly to the hyperglycemia characterizing patients with Type 2 diabetes. Fasting hyperglucagonemia induces hepatic glucose release resulting in elevated fasting levels of plasma glucose. Furthermore, lack of postprandial suppression of glucagon secretion - exchanged for a paradoxical postprandial hypersecretion of glucagon - results in increased levels of postprandial plasma glucose. Additionally, type 2 diabetes is characterized by decreased postprandial responses of the insulinotropic (and glucagonostatic) peptide hormone glucagon-like peptide-1 (GLP-1). Recent studies from our group suggest that the intestines are involved in the diminshed suppression of glucagon following ingestion of nutrients. Thus, suppression of glucagon during oral glucose ingestion diminishes and reverses to stimulation while suppression during intravenous administered glucose sustains along with development of glucose intolerance. In the small intestines mucosal endocrine L-cells secrete GLP-1, which is processed from its precursor, proglucagon, by prohormone convertase 1 (PC1). In the pancreatic alpha-cells proglucagon is processed to glucagon via prohormone convertase 2 (PC2). We plan to examine biopsies from the mucosa of the small intestines from patients with type 2 diabetes and from healthy subjects for glucagon production. Furthermore, the volunteers will be subjected to a standard meal test in order to correlate the gene expression studies with the level of postprandial hyperglucagonemia of the subjects.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 3 months
* Normal hemoglobin
* Informed consent

Exclusion Criteria:

* Liver disease (ALAT/ASAT \> 2 x normal range)
* Diabetic nephropathy (se-creatinin \> 130 µM and/or albuminuriu)
* Treatment with medication that can not be stopped for12 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Internal Medicine F' laboratory
state: Copenhagen County
Study officials:
affiliation: Department of Internal Medicine
name: Filip K Knop, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04066413: Growth and Tolerance Trial on Infant Formula With HMO
Official title: Growth and Tolerance Trial in Healthy Infants on Infant Formula Supplemented With a Human Milk Oligosaccharide
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Growth
Keywords: infant formula
human milk oligosaccharide
HMO
growth
Lead sponsor: FrieslandCampina
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 265
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.


Eligibility criteria: Inclusion Criteria:

* Gestational age ≥ 37 weeks
* Birth weight ≥ 2500 grams
* No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
* Boys and girls
* Recruited \< 1 month/age
* Being available for follow up until the age of 4 months
* Exclusive formula feeding or exclusive breast feeding at time of recruitment

Exclusion Criteria:

* Gestational age \<37 weeks
* Birth weight \<2500 grams
* Severe acquired or congenital diseases, mental or physical disorders
* Illness at screening/ inclusion
* Incapability of parents/caregivers to comply with the study protocol
* Received antibiotics within the first month of life
* Not tolerating standard cow's milk based infant formula
* Participation in another clinical trial
* Maternal illicit drug use during pregnancy or post-partum period
* Parent/caregiver does not have a cell phone to use for filling out questionnaires

Primary outcomes:
measure: Growth
timeFrame: From enrollment until end of the 3 month-study
Secondary outcomes:
measure: Weight
timeFrame: Monthly, from enrollment until end of the 3 month-study
measure: Recumbent length
timeFrame: Monthly, from enrollment until end of the 3 month-study
measure: Head circumference
timeFrame: Monthly, from enrollment until end of the 3 month-study
measure: Anthropometry z-scores
timeFrame: Monthly, from enrollment until end of the 3 month-study
measure: Formula tolerance
timeFrame: Monthly, from enrollment until end of the 3 month-study
measure: Gastro-intestinal comfort
timeFrame: Monthly, from enrollment until end of the 3 month-study
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT00577213: Diagnosis of Hemangiomas and Vascular Malformations
Official title: Diagnosis of Hemangiomas and Vascular Malformations Using Non-invasive Imaging Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemangiomas
Vascular Malformations
Venular Malformations
Venous Malformations
Lymphatic Malformations
Arteriovenous Malformations
Keywords: Diagnosis
Hemangiomas
Vascular Malformations
Venular Malformations
Venous Malformations
Lymphatic Malformations
Arteriovenous Malformations
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 56
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with vascular lesions from the patient populations at Arkansas Children's Hospital (ACH) and the University of Arkansas for Medical Sciences (UAMS) will be recruited for the study. Approximately 45 subjects from Arkansas Children's Hospital and approximately 10 subjects from the University of Arkansas for Medical Sciences will be recruited for a total of 55.

Brief summary: To develop a non-invasive, simple and affordable, measurement technique to differentiate hemangiomas from subtypes of VMS. The purpose of this study is to determine the best office based diagnositc instrument for differentiating the subtype of vascular lesions. The instrument must be simple and affordable so it can be used by primary car physicians in the doctor office. The procedure will be based on non-invasive and unharmful measurements that will be compared to the diagnosis from specialized physicians in this field and the final pathology.


Eligibility criteria: Inclusion Criteria:

* Suspected Hemangioma, Vascular Malformations (VMS) including venular Malformations (port-wine stain, PWS), Venous Malformations, Lymphatic Malformations, Arteriovenous Malformations or mixed malformations.

Exclusion Criteria:

* All pregnant individuals will be excluded, since physiologic changes of pregnancy could alter characteristics of the vascular lesion.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UAMS, ACH, Central Arkansas Veterans Healthcare System
name: Gal Shafirstein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UAMS, ACH, Central Arkansas Veterans Healthcare System
name: Jessica L Boswell
role: STUDY_DIRECTOR
References: