louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04506385: Metabolomic Effects of Probiotics Administration
Official title: Effects of Probiotics Administration on Human Metabolic Phenotype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolomic Profile
Lead sponsor: Probiotical S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: University of Florence
First posted: 2020-08-10
Enrollment: 42
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: The establishment of the beneficial interactions between the host and its microbiota is essential for the development and correct functioning of the organism, since microflora alterations can lead to many chronic degenerative diseases. In this context, probiotics are used to improve balanced microbial communities and therefore exert substantial health-promoting effects to the host.

Objective: The aim of the present study is to monitor the molecular outcomes, obtained by gut microflora modulation through probiotic treatment, on human urine and serum metabolic profiles, with a 1H-Nuclear Magnetic Resonance -based metabolomic approach.

Detailed description: Design: In a first phase twenty-two healthy subjects are enrolled in the study and administered with Lactobacillus delbrueckii subs. delbrueckii and/or a mix of 5 biotypes of Bifidobacterium longum for 8 weeks. In the second phase subjects are enrolled in the study and administered with Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus fermentum and Bifidobacterium longum at two different concentration. During the course of the study all the probiotic types were administered both singularly and in combination. From each subject urine and serum samples are collected before and during the supplementation and are analysed by nuclear magnetic resonance spectroscopy and statistical analyses.

Eligibility criteria: Inclusion Criteria:

- healthy subjects

Exclusion Criteria:

* previous surgery on the intestinal tract;
* a probiotic / prebiotic and antibiotic treatments within 3 and 1 months, respectively, before the beginning of the study;
* subjects have changed drastically their diet or lifestyle during the study.

Primary outcomes:
measure: metabolomic profile
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Azienda Ospedaliera-Universitaria Maggiore della carità di Novara
state: Piemonte
Study officials:
References:
Clinical trial NCT03422185: Understanding Local Determinants of Cardiovascular Disease and Diabetes
Official title: Understanding Local Determinants of Cardiovascular Disease and Diabetes to Inform Novel Interventional Strategies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Diabetes
Overweight and Obesity
Lead sponsor: Malawi Epidemiology and Intervention Research Unit
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 28891
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All adults within 2 defined geographical areas - one in urban Lilongwe, one in rural Karonga District

Brief summary: Cross-sectional survey of all adults residing in two defined geographical regions in urban Lilongwe and rural Karonga District. Participants were interviewed, had anthropometric measures taken, and had fasting blood specimens taken.


Eligibility criteria: Inclusion Criteria:

* all adults over 18 self-identifying as normally resident in the pre-defined geographical areas

Exclusion Criteria:

* None

Primary outcomes:
measure: What is the true burden of hypertension, diabetes, and hyperlipidaemia?
timeFrame: By end of 2018
Secondary outcomes:
measure: What is the prevalence of known risk factors - notably smoking, obesity, physical inactivity, alcohol, salt, and saturated fat intake?
timeFrame: By end of 2020
measure: Is infection, notably HIV infection or its therapy, associated with increased risk of NCDs?
timeFrame: By end of 2020
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: MEIRU
Study officials:
References:
citation: Prynn JE, Banda L, Amberbir A, Price AJ, Kayuni N, Jaffar S, Crampin AC, Smeeth L, Nyirenda M. Dietary sodium intake in urban and rural Malawi, and directions for future interventions. Am J Clin Nutr. 2018 Sep 1;108(3):587-593. doi: 10.1093/ajcn/nqy125.
Clinical trial NCT02313285: A Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668
Official title: An Open-label, Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progressive Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-12-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received study drug in the clinical study TDU13475

Brief summary: Primary Objective:

To assess the long-term safety of GZ402668 in patients with multiple sclerosis (MS) who received prior treatment during the TDU13475 or TDU14981 studies.

Secondary Objectives:

To assess the pharmacokinetics of GZ402668 in patients with MS. To assess the pharmacodynamics of GZ402668 in patients with MS. To assess the immunogenicity of GZ402668 in patients with MS.

Detailed description: The total study duration for a patient is approximately 47 months.

There is no administration of GZ402668 in the LTS14120 study. Patients who already received investigational medicinal product (GZ402668 or placebo) in TDU13475 or TDU14981 will be followed up to 47 months in the LTS14120.

Note: Patients from TDU14981 study (sanofi-sponsored) will participate in LTS14120 study. In order to keep consistent among all study related documents, the title of the LTS14120 study is not amended.

Eligibility criteria: Inclusion criteria:

Received investigational medicinal product (GZ402668 or placebo) in TDU13475 or TDU14981

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 4 years
measure: Safety, as assessed by clinical (physical examination), laboratory (hematology, creatinine, and urinalysis with microscopy), ECG, and vital sign events
timeFrame: monthly for up to 4 years
measure: Clinically significant changes in thyroid function tests from baseline
timeFrame: every 3 months for 4 years
Secondary outcomes:
measure: Time to lymphocyte repopulation
timeFrame: 4 years
measure: Number of patients with anti-drug antibodies
timeFrame: monthly for first 3 months then at 6 and 12 months for first 1 year
measure: Serum concentrations of GZ402668
timeFrame: monthly for first 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigational Site Number 276001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT00827385: Intraoperative Blood Pressure and Cognitive Performance
Official title: Impact of Intraoperative Blood Pressure on Cognitive Performance in Patients With and Without Hypertension: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Performance
Hypertension
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - individuals 40 years of age and older, undergoing laminectomy under general anesthesia.

Brief summary: The purpose of this study is to prospectively determine the association between incidence of neurological morbidity and minimum fractional blood pressure reached during laminectomy procedures under general anesthesia in hypertensive and normotensive subjects 40 years old and older.


Eligibility criteria: Inclusion Criteria:

* English as first language, or as a learned language as long as the patient is proficient
* No history of any neurological disease with the exception of patients without functional impairment who suffered a single episode of transient ischemic attack
* No history of axis I psychiatric diagnosis or drug abuse
* 40 years old or older
* Undergoing laminectomy under general anesthesia
* Must not take antihypertensive medication for purposes other than treatment of hypertension

Exclusion Criteria:

* Anyone who do not fit the inclusion criteria.

Primary outcomes:
measure: post-operative cognitive performance
timeFrame: 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian Hospital-Weill Cornell Medical College
state: New York
Study officials:
References:
Clinical trial NCT04221685: Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children
Official title: Intraoperative Pain During Extraction of Maxillary Primary Molars Using Artpharma Versus Artinibsa in Children After Infiltration Technique: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Keywords: Articaine
Extraction primary teeth
Infiltration technique
Postoperative pain
Intraoperative pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 130
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess Intraoperative pain for extraction of Maxillary primary molars using Artpharma Versus Artinibsa in children during infiltration technique.

Detailed description: Articaine is used for pain control Like other local anesthetic drugs, articaine causes a temporary and completely reversible state of anesthesia (loss of sensation) during (dental) procedures.This local anesthesia was first synthesized by Rusching in 1969, and carried to the market in Germany by Hoechst AG, a life-sciences German company, under the brand name Ultracain ,it entered clinical practice in Germany in 1976. The name was changed in 1984, the year it was released in Canada. It then entered the United Kingdom in 1998, the United States in 2000 and Australia in 2005. At this time, articaine is available as a 4% solution containing 1:100, 000 or 1:200, 000 adrenaline. Articaine has been widely used in dental surgery.It started to use carticaine around 1977.In dentistry has been investigated widely. Articaine is a unique amide LA in that it contains a thiophene, instead of a benzene ring.The thiophene ring allows greater lipid solubility and effectiveness as a greater portion of an administered dose can enter neurons

Eligibility criteria: Inclusion Criteria:

* Children aged 6-9 years.
* Children with maxillary primary molars indicated for extraction.

Exclusion Criteria:

* Children with medical conditions.
* Uncooperative children.
* Parents or guardians who refuse participating in the study.

Primary outcomes:
measure: Intraoperative pain.
timeFrame: immediate
Secondary outcomes:
measure: Pain during injection(success rate).
timeFrame: immediate
measure: Onset of anesthesia.
timeFrame: Immediate
measure: The sensation after injection.
timeFrame: Immediate
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04722185: Evaluation of the Veriton SPECT/CT System
Official title: Evaluation of the Veriton SPECT/CT System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Focus of Study is Comparison of 2 Types of Gamma Cameras
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: each patient will have 2 scans - one on a conventional system and one on the newer technology
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to evaluate a new type of gamma camera (the Veriton system) that provides a significant gain in system sensitivity and improved image quality compared to a conventional gamma camera that can achieve equal or better image quality than a standard SPECT/CT system.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 years or older.
* Currently scheduled to undergo a nuclear medicine exam.

Exclusion Criteria:

* Individuals under 18 years of age.
* Unwilling/unable to sign an informed consent form.
* Unable to lie on a Veriton imaging table for up to 40 minutes.

Primary outcomes:
measure: Image quality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Carrie Hruska, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01179685: Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer
Official title: Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilatral Pleural Effusion
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Melanoma antigen (MAGE) gene is known to be expressed in tumor cells, testis and placenta. The purpose of this prospective study was to investigate the sensitivity, specificity and accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis of malignant pleural effusion.


Eligibility criteria: Inclusion Criteria:

* unilateral pleural effusion on chest radiography

Exclusion Criteria:

* body temperature \> 38.3ºC and peripheral blood leukocytosis (\>12,000/μl)

Primary outcomes:
measure: The purpose of this prospective study was to investigate the sensitivity, specificity and accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis of malignant pleural effusion.
timeFrame: 12months interval
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sang-Won Um, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01354756: Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population
Official title: Validation of Apnea LinkTM (ResMed Corporation, Poway, California) for Sleep Apnea Syndrome Screening in a Bariatric Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sleep Apnea Syndrome
Keywords: sleep apnea
polysomnography
obesity
bariatric surgery
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2011-05-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese patients, \> 18y old, in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening

Brief summary: Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric surgery. There is a need for alternative screening tools for sleep apnea detection in the pre-operative period. The investigators would like to compare ApneaLink and complete polysomnography in this population.

Detailed description: OSA can occur in up to 78% of patients undergoing bariatric surgery(1). Moderate to severe case will benefit from CPAP therapy, that can help avoiding post-operative complications(2).

In this population, the investigators propose complete attended in-hospital polysomnography (PSG)in patients with a clinical high probability of OSA.

According to obesity epidemics (3), waiting list for PSG in sleep labs is every day longer.

The investigators want to assess sensitivity and specificity of a new portable screening tool, ApneaLink, to detect OSA in a bariatric population.

Design:

monocentric and prospective study

Methods:

Patients:

- OSA suspicion based on :

* symptoms and signs (snoring, apneas , neck circumference \>38 (women) or 43cm (men))
* BMI \> 50
* BMI \> 40, \> 40 y
* BMI \> 35, men, hypertension
* increased serum Bicarbonate
* Polyglobulia

Measurements

* Polysomnography in sleep lab with concommitant recording performed with Apnea LinkTM (nasal flow and oxymétry recording).
* between 2 weeks : recording performed with Apnea LinkTM (nasal flow and oxymétry recording)at home.

Eligibility criteria: Inclusion Criteria:

* obese patients
* \> 18 years old
* in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening

Exclusion Criteria:

* pulmonary, neurologic, neuromuscular disease
* \< 18 years old

Primary outcomes:
measure: Number of patients with correct diagnosis of OSA with ApneaLink. Therefore, we will compare apnea-hypopnea index measured with ApneaLink with apnea-hypopnea index measured during polysomnography.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU St Pierre
name: Marie Bruyneel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02962856: Human Phototoxicity Test (823/2016)
Official title: Human Phototoxicity Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine the phototoxic potential of a topically applied article in human subjects


Eligibility criteria: Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis;
* must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products

Primary outcomes:
measure: Intensity of skin reactions will be evaluated using the 5 point grading scale
timeFrame: Up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04464356: Application of Emergent Peripheral Mechanical Circulatory Support in Transcatheter Aortic Valve Replacement for 6 Patients
Official title: Application of Emergent Peripheral Mechanical Circulatory Support in Transcatheter Aortic Valve Replacement for 6 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transcatheter Aortic Valve Replacement
Mechanical Circulatory Support
Keywords: transcatheter aortic valve replacement
mechanical circulatory support
cardiopulmonary bypass
,extracorporeal membranous oxygenator
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients assisted by emergency peripheral MCS during TAVR due to circulatory collapse.

Brief summary: Objective: To explore the experience of transcranial aortic valve replacement (TAVR) under emergency mechanical assisted circulation (MCS).Methods: A total of 6 patients who completed TAVR with the assistance of emergency MCS in the Second Affiliated Hospital of Zhejiang University School of Medicine from March 2013 to June 2019 were retrospectively analyzed.The management of perioperative mechanical assisted circulation, preoperative evaluation, intraoperative operation and postoperative situation of patients were summarized.


Eligibility criteria: Inclusion Criteria:

* TAVR patient, assisted by emergency peripheral MCS due to circulatory collapse during TAVR

Exclusion Criteria:

* patients presented mechanical complications such as massive hemorrhage, coronary artery occlusion or left ventricular rupture.

Primary outcomes:
measure: 30-Day mortality rate
timeFrame: 30 days after TAVR procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: