louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05416892: What is the Impact of Implementing Pharmaceutical Algorithms in the PharmaClass® Software, on the Handling the Patient's Medication Load, by the Clinical Pharmacist?
Official title: What is the Impact of Implementing Pharmaceutical Algorithms in the PharmaClass® Software, on the Handling the Patient's Medication Load, by the Clinical Pharmacist? Analysis of These Impacts Within 2 Geriatric Units of the CHU Brugmann Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacist-Patient Relations
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 109
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patient entering the SU06 or SU13 geriatrics unit of the Paul Brien site of the CHU Brugmann Hospital between November 16 2021 and April 15, 2022

Brief summary: The clinical pharmacists present in the hospitalisation units aim to ensure the daily review of the drug prescriptions of hospitalized patients.

In order to optimize their work, the objective of this study would be to provide them with a clinical decision support tool via artificial intelligence in order to improve the patient's medication management. This study will test the Pharmaclass® software.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patient entering the SU06 or SU13 geriatrics unit of the Paul Brien site of the CHU Brugmann Hospital between November 16 2021 and April 15, 2022
* Speaking French and/or Dutch
* With chronic renal failure or taking at least one medicine for diabetes, heart, COPD, asthma, high blood pressure, epilepsy, atrial fibrillation, osteoporosis, high cholesterol, pain, parkinsonism, blood clotting, constipation, thyroid, depression, benign prostatic hypertrophy, gastric ulcer, Alzheimer's disease, cirrhosis as well as for electrolyte disorders (hypo or hypernatremia / potassium / calcium/magnesemia/phosphatemia).

Exclusion Criteria:

* Patient who died or was transferred to another care unit during his/her hospitalization

Primary outcomes:
measure: Time
timeFrame: 5 months
measure: Dosage compliance
timeFrame: 5 months
measure: Medication error severity
timeFrame: 5 months
measure: Geriatrician approval
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Brugmann university hospital
Study officials:
affiliation: CHU Brugmann
name: Charline DANNEEL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03763292: Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery
Official title: Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery on the Parents' Preparedness for Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Consumer Satisfaction
Keywords: Parents
Patient Education as Topic
Preoperative Care
Pamphlets
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Helse Nord-Trøndelag HF
First posted: 2018-12-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Children who will have surgery and need anesthesia, and their parents are often anxious and show signs of stress and discomfort. A main reason for concern and anxiety is fear of anesthesia and surgery, and lack of knowledge of what is going to happen. The purpose of the study is to see if a specific preoperative information brochure aimed at the parents will make the parents feel better prepared for the procedures.


Eligibility criteria: Inclusion Criteria:

* Parents with children undergoing ear-nose-throat surgery in the study period

Exclusion Criteria:

* Parents who do not speak nor read Norwegian.
* Parents who do not want to participate

Primary outcomes:
measure: Satisfaction with information
timeFrame: 10 minutes
measure: Preparedness for the operating room setting
timeFrame: 10 minutes
Secondary outcomes:
measure: Perceived Stress Score (PSS-14)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Sykehus Levanger
Study officials:
affiliation: Norwegian University for Science and Technology
name: Siri Forsmo, phd prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03834389: The Effect of Case-Based Learning Method on Perceived Competence and Critical Thinking Levels
Official title: The Effect of Case-Based Learning Method on Perceived Competence and Critical Thinking Levels in Nursing Students: Mixed Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Keywords: case- based learning
critical thinking
self-efficacy
nursing education
nursing
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Second-year nursing students are randomly assigned to experimental and control groups. The case-based teaching method was applied to the experimental group and the classical teaching method was applied to the control group. After the initiative, both groups observed differences in perceived competence and critical thinking levels. In addition, the focus groups were interviewed with the experimental group and the opinions and suggestions about the initiative were evaluated qualitatively and the total mix method was used.

Detailed description: Nursing secondary school students were randomized into two groups. Case-based training was given to the experimental group, and classical training was given to the control group. Critical thinking scale and self-efficacy scale both before and after the training were applied to both groups. Posttest scores were calculated and compared for both groups. The focus group consultation with 10 people from the experimental group was carried out and the opinions and suggestions about the initiative were taken and evaluated. Permission was obtained in writing from all institutions before and after the participants, and the study was conducted by creating ethical conditions.Four separate training cases were given to the experimental group. the control group continued the classical training and no intervention was made.

Eligibility criteria: Inclusion Criteria:

* Become a nursing 2nd year student
* Want to participate in the research
* Not to be in the health profession
* Having passed the course of internal medicine nursing
* Being the first to see the surgical diseases nursing course
* Be able to devote time for case discussions outside of class

Exclusion Criteria:

- Being a foreign national (Unable to speak / understand Turkish effectively)

Primary outcomes:
measure: CRITICAL THINKING TENDENCY SCALE
timeFrame: 4 months
measure: Effect of case-based learning method on self-efficacy level
timeFrame: 4 months
Secondary outcomes:
measure: Focus group interview
timeFrame: 4 months
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selçuk Univercity
state: Selçuklu/Konya
Study officials:
References:
Clinical trial NCT00226889: Treatment of Early Systemic Sclerosis by Bosentan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Systemic Sclerosis (Scleroderma)
Keywords: Scleroderma
Fibrosis
Therapy
Bosentan
Endothelin-1
Lead sponsor: Rikshospitalet University Hospital
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. Using drugs that are capable of inhibiting fibroblast activity may be beneficial if administrered early in the disease course. Thirty adult patients with early SSc will be treated with the endothelin-1 antagonist bosentan for 6 months.Disease progression will be assessed.

Detailed description: Systemic sclerosis (SSc) is characterised by obliterative vasculopathy and extensive fibrosis. The accumulation of extracellular components in the extracellular matrix is mostly due to increased activity og tissue fibroblasts. The proliferation and hyperactivity of the fibroblasts may be caused by enhanced production of several cytokins, among them endothelin-1.The activity of endothelin-1 has been shown to be increased both in the circulation and within skin lesions. Endothelin-1 has several distinct properties, among them profibrotic activity, inflammatory and vasoconstriction.Thus, the actions induced by endothelin-1 may be a potensial target for the therapy of SSc.

Thirty patients with early SSc, that is of less than 12 months duration will be offered six months of treatment with the oral dual endothelin-1 antagonist bosentan. Assessment of disease progression will be performed at 3, 6, 9. 12 and 24 months using clinical, histological and immunohistochemical methods.

Eligibility criteria: Inclusion Criteria:

* Early systemic sclerosis

Exclusion Criteria:

* Age \> 70 or \< 18
* Pregnancy
* Nursing
* HIV
* Hb \< 8.5 g/l
* Systolic blood pressure \< 85 mmHg
* Lack of compliance
* Liver disease
* Hypersensitivity to bosentan
* Concurrent us of glibenclamide, ciclosporine A or tacrolimus -

Primary outcomes:
measure: Overall clinical progression
measure: Degree of deposition of ET-1 in skin
Secondary outcomes:
measure: Development of extradermatological manifestations
measure: Quality of life
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of rheumatology, Rikshospitalet
Study officials:
affiliation: department of rheumatology
name: Jan T Gran, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004489: Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
disease-related problem/condition
genetic diseases and dysmorphic syndromes
osteoporosis
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone metabolism in patients with cystic fibrosis.

II. Assess the safety and efficacy of this treatment regimen in improving osteoporosis in this patient population.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind study. Patients will be stratified according to sex (male vs female) and osteoporosis disease severity (mild vs severe). Patients are randomized to one of two treatment arms.

Patients undergo bioavailability assessment to confirm the ability to absorb alendronate.

Arm I: Patients receive calcium and vitamin D supplements with a placebo daily for one month.

Arm II: Patients receive calcium and vitamin D supplements with oral alendronate daily for one month.

Treatment continues if differences are seen in bone mineral density between the treatment arms.

Patients are followed for biochemical response at week 6, 12, and 52. Bone mineral density is measured at 1 year and 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of cystic fibrosis Mild to moderate lung disease
* At least one site specific (spine or femur) bone mineral density representing low bone mass or osteopenia (greater than 1 standard deviation below peak bone mass)

--Prior/Concurrent Therapy--

* Endocrine therapy: At least 3 months since prior corticosteroids

--Patient Characteristics--

* Performance status: Ambulatory
* Renal: Creatinine no greater than 3 mg/dL No renal failure
* Other: No history of esophagitis No allergies to alendronate Not pregnant Fertile female patients must use effective barrier contraception or progestin only oral contraceptives (e.g., norethindrone) Ability to comply with treatment No intestinal problems other than cystic fibrosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Robert Aris
role: STUDY_CHAIR
References:
Clinical trial NCT00232089: Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Official title: Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: Dyspepsia, gastrointestinal, tegaserod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 1296
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.


Eligibility criteria: Inclusion Criteria:

* Female patients, 18 years and older
* Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia; for at least 12 weeks, not necessarily consecutive, during the previous 12 months.

Exclusion Criteria:

* Abnormal esophago-gastro-duodenoscopy (EGD) endoscopy findings such as any esophageal mucosal break, gastric erosions, gastric ulcers and/or duodenal ulcers/erosions on an EDG exam performed with 12 weeks prior to baseline.
* Current or history of erosive esophagitis confirmed by EGD
* Heartburn occurring 3 or more days a week.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of postprandial fullness early satiety and bloating)
Secondary outcomes:
measure: Weekly assessment of satisfactory relief of dyspepsia.
measure: Daily assessment of percentage of patients responding on average severity score.
measure: For each week assessment of average daily severity score.
measure: Percentage of days with satisfactory relief of dyspepsia during each week.
measure: Weekly global assessment of change in dyspepsia condition.
measure: Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
measure: Quality of life at end of treatment compared to baseline.
measure: Safety and tolerability.
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: East Hanover NJ
name: Novartis
role: STUDY_CHAIR
References:
citation: Vakil N, Laine L, Talley NJ, Zakko SF, Tack J, Chey WD, Kralstein J, Earnest DL, Ligozio G, Cohard-Radice M. Tegaserod treatment for dysmotility-like functional dyspepsia: results of two randomized, controlled trials. Am J Gastroenterol. 2008 Aug;103(8):1906-19. doi: 10.1111/j.1572-0241.2008.01953.x. Epub 2008 Jul 4.
Clinical trial NCT02513589: Molecular Imaging of Inflammation With 18F-PBR06 to Identify Unstable Carotid Plaques in Patients With Stroke
Official title: Molecular Imaging of Inflammation With 18F-PBR06 to Identify Unstable Carotid Plaques in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke
Keywords: Positron emission tomography
Carotid plaque
Inflammation
Stroke
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluating an innovative molecular imaging technique to visualize inflammation of the atherosclerotic plaque in patients with a recent ischemic stroke (\<15 days) with carotid stenosis\> 50%, by performing a Positron emission tomography-computed tomography (PET-CT) with PBR06 18F, a tracer for Translocator protein (TPSO).

Detailed description: More than one third of cerebral ischemic events are related to an atheromatous plaque. Inflammation, through a key player, the macrophage, is associated with increased metabolic activity of atherosclerotic plaque and its possible rupture. Inflammation within the plate is thus a marker of instability. These data underscore the importance of a prospective evaluation of inflammation with specific imaging with PET tracers inflammation.

Eligibility criteria: Inclusion Criteria:

* Man with transient ischemic attack or recent ischemic stroke (\<15j) in the carotid territory, confirmed by MRI
* Man with carotid stenosis\> 50% on the side of stroke
* Male candidate for carotid endarterectomy
* Subject affiliated or beneficiary of a social security scheme
* Informed written consent

Exclusion Criteria:

* Women
* Chronic inflammatory disease in progress (cancer, vasculitis, ...)
* Patient with infection within 7 days
* A person placed under judicial protection, guardianship
* Incapable of giving consent
* Low affinity binder for TSPO

Primary outcomes:
measure: Correlation between the value of standardized uptake value (SUV) on PET-CT with 18F-PBR06 and the degree of macrophage infiltration at histological examination
timeFrame: 15 days
Secondary outcomes:
measure: Levels of leukocyte and T lymphocyte inflammation of the plaque
timeFrame: 15 days
measure: Plaque parameters composite
timeFrame: 15 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Paolo ZANOTTI-FREGONARA
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Paul Perez
role: STUDY_CHAIR
References:
citation: Schollhammer R, Lepreux S, Barthe N, Vimont D, Rullier A, Sibon I, Berard X, Zhang A, Kimura Y, Fujita M, Innis RB, Zanotti-Fregonara P, Morgat C. In vitro and pilot in vivo imaging of 18 kDa translocator protein (TSPO) in inflammatory vascular disease. EJNMMI Res. 2021 May 5;11(1):45. doi: 10.1186/s13550-021-00786-7.
Clinical trial NCT01580189: Whole Milk Versus Whey Protein Supplement and Resistance Exercise
Official title: Effects of Whole Milk Versus Whey Protein Supplementation With Resistance Exercise on Body Composition, Muscle Hypertrophy and Strength Changes in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Development
Keywords: Lean tissue
Strength condition
Protein
Amino Acid
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to examine the effects of consuming protein supplement (whey) compared to whole milk immediately after bouts of resistance training on muscular strength and body composition.


Eligibility criteria: Inclusion Criteria:

* healthy
* currently working out at least 3 times per week

Exclusion Criteria:

* taken any ergogenic aid/sport supplements in the last 2 months

Primary outcomes:
measure: Body composition
timeFrame: 9 weeks
measure: Strength
timeFrame: 9 weeks
Secondary outcomes:
measure: Blood amino acid
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Semone B Myrie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05006989: Blueberry Intake and Infant Gut Health
Official title: Blueberry Intake and Infant Gut Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Keywords: Blueberries
Gut microbiota
Inflammation
Innate immunity
Early complementary feeding
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: U.S. Highbush Blueberry Council
First posted: 2021-08-16
Enrollment: 75
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this project is to investigate the effects of blueberries on gut microbiota, inflammation and innate immunity in breastfed infants during early complementary feeding (\~5 to 12 months of age).

Detailed description: Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.

Eligibility criteria: Inclusion Criteria:

* Generally healthy
* Full term (gestational age ≥ 37 weeks)
* No prior exposure of solid foods
* Exclusively breastfed (\< 2 weeks of cumulative formula exposure)
* Willing to consume blueberry/placebo powder

Exclusion Criteria:

* Having health conditions that would affect normal growth
* Pre-term
* Consumed formula for more than two weeks
* Not willing to consume the blueberry/placebo powders

Primary outcomes:
measure: Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing
timeFrame: Over 7 months
measure: Infant Growth (Length)
timeFrame: Over 7 months
measure: Infant Growth (Weight)
timeFrame: Over 7 months
measure: Dietary Intake
timeFrame: Over 7 months
Secondary outcomes:
measure: Blueberry-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis
timeFrame: Over 7 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado Denver | Anschutz
name: Minghua Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: