louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04462627: Reduction of COVID 19 Transmission to Health Care Professionals
Official title: Reduction of COVID 19 Transmission to Health Care Professionals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID 19
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate.

The pulmonary epithelial cells of a part of the population, known as "secretors", are capable of expressing the antigens of the "ABO" system on their surface. This secretory status can be established by determining the antigens of the Lewis blood group system. When the virus replicates in an "secreting" individual, the antigens of the "ABO" system of the infected individual will be present on the surface of the viruses formed in his/her lungs.

It was shown in 2003 that the response of a given individual to the transmission of a virus depends on his/her blood group and on the antigens of the "ABO" system carried by the virus. A patient of group "O" would thus defend himself much better against a virus carrying antigens of blood group "A", the natural antibodies "anti-A" of the patient reducing the ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to penetrate them to replicate itself. The first data collected in Wuhan (China) seems to confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on the basis of blood groups.

In order to reduce the spread of the virus among nursing staff, it is possible to establish a preferential algorithm for patient management based on the "ABO" and "Lewis" blood groups of patients and "ABO" of nursing staff in health care units, if operational and human conditions allow.


Eligibility criteria: Inclusion Criteria:

* COVID19 positive patients admitted within the CHU Brugmann Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Anti-A antibody concentration
timeFrame: baseline
measure: Anti-A antibody concentration
timeFrame: Day 4
measure: Anti-A antibody concentration
timeFrame: Week 1
measure: Anti-A antibody concentration
timeFrame: Week 2
measure: Anti-A antibody concentration
timeFrame: Week 3
measure: Anti-B antibody concentration
timeFrame: baseline
measure: Anti-B antibody concentration
timeFrame: Day 4
measure: Anti-B antibody concentration
timeFrame: Week 1
measure: Anti-B antibody concentration
timeFrame: Week 2
measure: Anti-B antibody concentration
timeFrame: Week 3
measure: Blood group
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Hanane El Kenz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02419027: A Multi-center Human Study to Evaluate the Efficacy and Safety of ®GI Flora in Subjects With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: GI Flora
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 116
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Randomized, Double-blinded, Placebo-controlled Human Study to Evaluate the Efficacy and Safety of probiotic mixture(®GI Flora) in Subjects with Irritable Bowel Syndrome.

Regimen: 6 probiotics mixture \>10\^9/D for 8 weeks

Primary variable: visual analogue scale(VAS) assessment for abdominal pain

Secondary variable:

1. change of VAS score for abdominal pain/discomfort after 4/8-week treatment
2. daily symptom score for bloating, defecation discomfort(strain/urgency/incomplete evacuation), flatulence , feces shape, frequency of bowel movements


Eligibility criteria: Inclusion Criteria:

* Irritable bowel syndrome patients according to Rome III criteria
* Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.

Exclusion Criteria:

* Intolerable or hypersensitive to GI Flora.
* Patients with active colon diverticulitis.
* History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation.
* History of inflammatory bowel disease, malignancy requiring surgery or chemotherapy or radiation within 5 years.
* Patient has any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the requirements of the study.

Primary outcomes:
measure: Visual Analogue Scale for abdominal pain
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02988427: Measuring Patient Engagement in Diabetes Care
Official title: Measuring Patient Engagement in Diabetes Care
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Mellitus, Type II
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of North Carolina
First posted: 2016-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients ages 21 and older will be recruited from study clinics

Brief summary: We will develop a new measure of patient engagement/activation specific to the context of diabetes self-care


Eligibility criteria: Inclusion Criteria:

1. Patient is age 21 and older
2. Patient is English speaking
3. Patient has been diagnosed with Type II Diabetes by a health care provider

Exclusion Criteria:

1. Severe, uncorrectable vision
2. Hearing impairments
3. Cognitive impairment

Primary outcomes:
measure: Diabetes Self-efficacy
timeFrame: Baseline
Secondary outcomes:
measure: Diabetes Distress
timeFrame: Baseline
measure: Functional Health Status
timeFrame: Baseline
measure: Clinical Outcomes
timeFrame: 3 months before baseline to 3 months after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Michael Wolf, PhD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Stacy Bailey, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05479227: Bile Duct Injuries During Laparoscopic Cholecystectomies: An 11-year Population-based Study
Official title: Bile Duct Injuries During Laparoscopic Cholecystectomies: An 11-year Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Duct Injury
Lead sponsor: North Estonia Medical Centre
Sponsor class: OTHER
Collaborators: name: University of Tartu
First posted: 2022-07-29
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of patients who experienced a bile duct injury during laparoscopic cholecystectomy during 2008-2018 in Estonian national health care facilities. The data was obtained according to coding in National Health Insurance Fund electronic database. Data on readmissions related to BDIs and their subsequent complications were collected from the National Institute for Health Development repository.

Brief summary: The aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) in a population-based cohort during 2008-2018 in Estonia.

Detailed description: The aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) in a population-based cohort during 2008-2018 in Estonia.

Background Data: Iatrogenic bile duct injuries (BDI) following laparoscopic cholecystectomy (LC) result in major morbidity and incidental mortality. There is a lack of unselected population-based cross-sectional studies on the incidence, management, and outcomes of BDI. We hypothesised that due to improved imaging capabilities and collective laparoscopic experience, the BDI incidence will decrease over the study period and compare favourably with contemporary literature.

After IRB approval, all cholecystectomies performed at national public healthcare facilities between 2008 and 2018 were retrospectively reviewed. BDIs were classified according to the Strasberg classification. We hypothesized that due to improved imaging capabilities and collective laparoscopic experience the BDI incidence will decrease over the study period and compare favourably to contemporary literature.

Eligibility criteria: Inclusion Criteria:

* all patients with BDI during laparoscopic cholecystectomy (LC)

Exclusion Criteria:

* The sole exclusion criterion in the case selection was cholecystectomy performed primarily using the open method

Primary outcomes:
measure: incidence of bile duct injuries
timeFrame: During the years 2008-2018
Secondary outcomes:
Other outcomes:
Locations:
city: Tallin
country: Estonia
facility: Arvo Reinsoo
Study officials:
affiliation: North Estonia Medical Centre
name: Arvo Reinsoo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00549627: Evaluation of the PediGuard™ for Pedicle Screw Insertion
Official title: Evaluation of the PediGuard™ for Pedicle Screw Insertion
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Posterior Spinal Fusion
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2007-10-26
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the study is to determine the relative effectiveness of the PediGuardTM , a device manufactured by SpineVision, Inc, for placement of a pedicle screw pilot (drill) hole and for reducing pedicle screw breaches during thoracic and lumbar pedicle screw fixation of the spine.

Hypothesis #1 The PediGuardTM will be more accurate for pedicle screw placement as compared to other standard manual techniques of similar size of pedicle screw insertion. At least 90% of screws placed with the PediGuardTM will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan). In contrast, only 80% of screws using manual placement will be positioned correctly in the pedicle.

Hypothesis #2 The PediGuardTM will not be inferior to fluoroscopic techniques for pedicle screw insertion. Both techniques will achieve at least 90% accuracy in the placement of pedicle screws.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary spinal fusion with pedicle screw fixation of the spine anywhere from T1to S1
* Subjects must be skeletally mature as defined by closed growth plates on wrist via radiographs
* Written informed consent and assent (assent for adolescents)

Exclusion Criteria:

* Pedicle screw insertion by image guided techniques, including Fluoronav
* Tumor
* Diagnoses associated with diminished bone mineral density such as osteogenesis imperfecta, severe osteopenia, neurofibromatosis
* Severe senile osteoporosis (\> 2 standard deviations below the norm)
* Women who are pregnant
* Children with open growth plates
* Previously fused spinal levels
* Unwillingness to sign written informed consent and assent.

Primary outcomes:
measure: At least 90% of screws placed with the PediGuard™ will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan).
timeFrame: Post-op CT prior to discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Golden
country: United States
facility: Panorama Orthopedics and Spine Center
state: Colorado
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Louisville
country: United States
facility: Spine Institute
state: Kentucky
city: NY
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: Philadelphia
country: United States
facility: Shriners Hospitals for Children
state: Pennsylvania
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
Study officials:
affiliation: Shriners Hospitals for Children
name: Randal Betz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02619227: A Livelihood Intervention for Impoverished Women in Rural Uganda
Official title: A Livelihood Intervention for Impoverished Women in Rural Uganda: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Indigency
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
First posted: 2015-12-02
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of the study is to determine whether a livelihood intervention can improve economic and psychosocial wellbeing in rural Uganda.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-60 years (or emancipated minors aged 16-17 years) who live with at least one child under the age of 5 in the same household
* Women aged 18-60 years (or emancipated minors aged 16-17 years) who agree to participate in the livelihood intervention training program
* Women aged 18-60 years (or emancipated minors aged 16-17 years) who agree to participate in study data collection

Exclusion Criteria:

* Men
* Women who do not live in Nyakabare Parish
* Women under 18 years of age (if not emancipated minors) or older than 60 years of age
* Women who do not live with at least one child under the age of 5 in the same household
* Women who decline to participate in the livelihood intervention training program
* Women who decline to participate in study data collection
* Women who live in the same household as another study participant

Primary outcomes:
measure: Household Food Insecurity Access Scale
timeFrame: 12 months
measure: Hopkins Symptom Checklist Scale
timeFrame: 12 months
Secondary outcomes:
measure: Intimate Partner Violence Scale
timeFrame: 12 months
measure: Norms about Intimate Partner Violence Scale
timeFrame: 12 months
measure: Self-Reported Health Scale
timeFrame: 12 months
measure: Decision Making Power Scale
timeFrame: 12 months
measure: Social Integration Scale
timeFrame: 12 months
measure: Social Capital Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: Massachusetts General Hospital
name: Alexander C Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mbarara University of Science and Technology
name: Bernard Kakuhikire, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weil AA, Debela MD, Muyanja DM, Kakuhikire B, Baguma C, Bangsberg DR, Tsai AC, Lai PS. Gut carriage of antimicrobial resistance genes in women exposed to small-scale poultry farms in rural Uganda: A feasibility study. PLoS One. 2020 Jun 11;15(6):e0229699. doi: 10.1371/journal.pone.0229699. eCollection 2020.
Clinical trial NCT01229527: Comparison Between Two Different Dosages of Remifentanil During Colonoscopy
Official title: Comparison Between Two Different Dosages of Remifentanil Administered by PCSA (Patient Controlled Sedation and Analgesia) and Meperidine During Colonoscopy: A Randomized Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Keywords: Colonoscopy
Remifentanil
Sedation
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this randomized double-blind trial is to define the correct dosage of Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and side effects.

90 patients undergoing colonoscopy will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Adult Patients
* Diagnostic and Operative Colonoscopy
* ASA Physical Status I-II

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Discharge Time, the Time to Reach a Modified Aldrete Score ≥18
timeFrame: > 0 minutes
Secondary outcomes:
measure: Patient's Satisfaction
timeFrame: After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
Clinical trial NCT04605627: The Role of Gut Leakage Markers and Microbiota Signature in Coronary Artery Disease.
Official title: The Role of Gut Leakage Markers and Microbiota Signature in Coronary Artery Disease.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Intestinal Disease
Keywords: Gut leakage
Microbiota
Coronary artery disease
STEMI
NSTEMI
Chronic coronary syndrome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2020-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 20-75 years with coronary artery disease.

Brief summary: Define a signature of gut microbiota composition and related metabolites in patients with ST-elevation myocardial infarction, non ST-elevation myocardial infarction and chronic coronary disease (CAD).

Detailed description: A total of 200 patients, allocated to 50 patients with chronic coronary syndrome, 75 patients with non-ST elevation myocardial infarction and 75 patients with ST- elevation myocardial infarction will be included. Clinical information, blood samples and fecal samples will be collected. Fecal and blood samples will be collected once in patients With chronic disease and in patients with acute coronary syndrome; in the acute phase and after 3 months.

Eligibility criteria: Inclusion Criteria:

* Coronary heart disease verified by coronary angiography

Exclusion Criteria:

* Current infection requiring intravenous antibiotics
* Inflammatory bowel disease
* Renal failure with creatinine \> 200µmol/L
* Hepatic impairment
* Pregnancy
* Previous bariatric surgery
* Colostomy
* Active malignant disease

Primary outcomes:
measure: Microbiota alpha diversity in myocardial infarction measured as Chao1 Index.
timeFrame: Within 7 days from inclusion.
measure: Microbiota alpha diversity in myocardial infarction measured as Chao1 Index
timeFrame: At 3 months follow-up.
measure: Lipopolysaccharide binding protein (LBP) in myocardial infarction
timeFrame: At inclusion
measure: Lipopolysaccharide binding protein (LBP) in myocardial infarction
timeFrame: Change from inclusion to 3 months follow-up.
measure: Soluble cluster of difference-14 in myocardial infarction
timeFrame: At inclusion
measure: Soluble cluster of difference-14 in myocardial infarction
timeFrame: Change from inclusion to 3 months follow-up.
measure: Intestinal fatty acid binding protein-1 in myocardial infarction
timeFrame: At inclusion
measure: Intestinal fatty acid binding protein-1 in myocardial infarction
timeFrame: Change from inclusion to 3 months follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Cardiology, Oslo University Hospital Ullevål
Study officials:
affiliation: Oslo University Hospital
name: Marius Trøseid, Md Ass.prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770627: Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children
Official title: A Randomized , Controlled, Doulbe Blind Placebo Trial To Evaluate The Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: 160 children
parallel group
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities, anxiety and depression.

The omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could avoid the intake the methylphenidate and its associated adverse side effects.


Eligibility criteria: Inclusion Criteria:

* 6 to 15 years and 11 months of age ADHD children with hyperactivity confirmed dy DSM IV criteria Children and parents' consent

Exclusion Criteria:

* Without methylphenidate treatment Fish or other sea products allergic Intake of sea omega 3 fatty acids supplments more one week during 3 months before the trial Children need quickly to take methylphenidate: social, family, or school risk Intake methylphenidate 30 days before the trial or/and intake it during one consecutive week

Primary outcomes:
measure: ADHD rating scale
timeFrame: 5 minutes
Secondary outcomes:
measure: Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity)
timeFrame: 3 hours
Other outcomes:
Locations:
city: Bron
country: France
facility: Clinical Investigation Center
city: Bron
country: France
facility: Hopital Cardiovasculaire Louis Pradel
Study officials:
References: