louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05355857: Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.
Official title: Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Diseases
Keywords: FDG PET
PET-MRI
atlas
brain
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
Collaborators: name: ICube Laboratory
First posted: 2022-05-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy volunteers
Primary purpose: DIAGNOSTIC

Brief summary: With 18F-FDG PET, we have few atlases of normality allowing the realization of objective quantitative analyses. An atlas of normality is a probabilistic atlas of normal FDG uptake from a representative set of brain PET images of healthy subjects. This type of atlas is essential for intra- and inter-individual comparisons.

Accurate quantitative analysis of brain 18F-FDG PET images acquired on a hybrid PET system has been shown to require an institutional normal database for statistical analyzes (Akdemir et al., JNM 2017 and Della Rosa et al Neuroinformatics, 2014).

Detailed description: This is a prospective, monocentric, non-randomized study, with no direct individual benefit since it involved healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 20 to 50
* Absence of any history or cardiovascular, neurological or psychiatric deficit
* Signed the informed consent

Exclusion Criteria:

* Contraindication to the realization of an MRI or PET and to the injection of 18F-FDG
* People using a pacemaker or insulin pump
* People wearing a metal prosthesis or an intracerebral clip
* People with intraocular metal splinters
* People with a pathology considered incompatible for the production of the atlas according to the investigator
* Pregnant women and breastfeeding women
* Subject in period of exclusion.

Primary outcomes:
measure: Creation, from a representative set of brain PET-MRI images of healthy subjects, of a probabilistic atlas of normal FDG uptake in healthy volunteers
timeFrame: 30 minutes after 18F-FDG injection
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
References:
Clinical trial NCT06391957: Spirulina Supplementation In Recovery From Damaging Exercise
Official title: Spirulina Supplementation In Recovery From Damaging Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Damage Muscle
Keywords: spirulina
exercise recovery
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exercise can cause muscle damage, leading to a loss in muscle function, increased muscle soreness and inflammation. Evidence supports the use of nutritional strategies to help recovery. Spirulina is a type of algae. It is eaten as a food supplement as it is full of micronutrients, some which provide anti-inflammatory benefits. This work will assess the impact of taking spirulina supplements on recovery from hard exercise. Investigators will measure changes in muscle function, soreness and markers of inflammation.


Eligibility criteria: Inclusion Criteria:

* Are available and willing to attend St Luke's Campus, Exeter
* Age 18 - 40
* BMI 18.5 - 30 kg/m2
* The participant exercises / plays sport for \> 2 h/week, but doesn't do structured resistance strength training
* Self-reported as healthy (absence of injury or disease)
* Have no known food allergy to algae
* Are not taking any over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication
* Non-smoker

Exclusion Criteria:

* Are unable to attend St Luke's Campus, Exeter
* Are out-with age range 18 - 40
* BMI below 18.5 or above 30 kg/m2
* The participant does not exercise
* The participant does regular structured resistance strength training
* Known injury or disease that might influence study outcomes
* Have a known food allergy to algae
* Are taking over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication
* Smoker

Primary outcomes:
measure: Measure changes in the concentration of blood plasma inflammatory markers via immunoassay.
timeFrame: Measurements take place across a 6 day experimental period.
Secondary outcomes:
measure: Measure changes in muscle function of the quadriceps using knee extensor peak isometric torque on a Biodex System 3 isokinetic dynamometer.
timeFrame: Measurements take place across a 6 day experimental period.
measure: Measure changes in muscle function of the quadriceps using knee extensor total isokinetic work on a Biodex System 3 isokinetic dynamometer.
timeFrame: Measurements take place across a 6 day experimental period.
measure: Measure changes in perceived lower body muscle soreness via visual analogue scale questionnaire.
timeFrame: Measurements take place across a 6 day experimental period.
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
References:
Clinical trial NCT00636857: Postoperative Hyponatremia - Are There Gender Differences?
Official title: Postoperative Hyponatremia - Are There Gender Differences?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyponatremia
Keywords: Water-Electrolyte Imbalance
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2008-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will focus on anesthesia and anesthesia-induced hypotension as a possible cause for postoperative fluid retention and hyponatremia, and investigate gender differences in this response.

Detailed description: 30 healthy women and 30 healthy men, who are scheduled for surgery of the middle ear or parotic gland are included in the study. Within each gender group, the subjects are randomized to receive perioperative intravenous fluid regimes either based on body weight or lean body mass (LBM). The surgery lasts for at least 3 hours, the intervention period (fluid administration according to protocol) will last 10-12 hours, the study period will be 20-24 hours. Blood samples for analysis of plasma sodium, potassium, glucose and osmolality are collected preoperatively and the following morning together with analysis of urine produced during the study period.

Eligibility criteria: Inclusion Criteria:

* ASA Physical status I-II
* Subjects scheduled for otorinolaryngoiatric surgery in general anesthesia of at least 3 hours duration

Exclusion Criteria:

* BMI less than 18
* BMI greater than 33
* Diabetes mellitus requiring medication
* Treatment with diuretics
* ACE-inhibitors
* Angiotensin II antagonists
* Cortisone
* Lithium
* Diseases of the kidney
* Females:

  * Pregnancy
  * Menopause
  * Endocrine dysfunction influencing menstruation

Primary outcomes:
measure: Change between preoperative and postoperative plasma sodium concentration
timeFrame: 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Dept of Anaesthesia and Intensive Care, Kalmar County Hospital
city: Linkoping
country: Sweden
facility: Department of Anaesthesia and Operation
city: Stockholm
country: Sweden
facility: Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge
city: Stockholm
country: Sweden
facility: Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna
city: Uppsala
country: Sweden
facility: Dept of Anaesthesia and Intensive Care, Uppsala University Hospital
Study officials:
affiliation: Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm,
name: Johan Ullman, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02345057: A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Type 2 Diabetes Mellitus and Microalbuminuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Keywords: Diabetic Nephropathy
mineralocorticoid receptor antagonist
CS-3150
Japanese
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 365
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2 Diabetes Mellitus and Microalbuminuria.

The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes mellitus
* Male or female subjects aged 20 years or older at informed consent
* Subjects with urinary albumin to creatine ratio (UACR) ≥ 45 mg/g Cr and \< 300 mg/g Cr
* Estimated glomerular filtration rate by creatinine (eGFRcreat) ≥ 30 mL/min/1.73 m\^2
* Subjects treated with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 3 months prior to treatment period

Exclusion Criteria:

* Type 1 diabetes
* HbA1c (NGSP) \>=8.4%
* Secondary glucose intolerance
* Subjects diagnosed with non-diabetic nephropathy
* Nephrotic syndrome
* Secondary hypertension or malignant hypertension
* Serum potassium level in any of the following categories: For subjects with eGFRcreat of ≥ 45 mL/min/1.73 m\^2, serum potassium level of \< 3.5 mEq/L or ≥ 5.1 mEq/L; For subjects with eGFRcreat of ≥ 30 mL/min/1.73 m\^2 and \< 45 mL/min/1.73 m\^2, serum potassium level of \< 3.5 mEq/L or ≥ 4.8 mEq/L

Primary outcomes:
measure: Change from baseline in urinary albumin to creatine ratio (UACR)
timeFrame: Baseline to end of Week 12
Secondary outcomes:
measure: Transition from microalbuminuria to normoalbuminuria
timeFrame: Baseline to end of Week 12
measure: Change in renal function
timeFrame: Baseline to end of Week 12
measure: Change in serum potassium
timeFrame: Baseline to end of Week 12
Other outcomes:
Locations:
city: Kumamoto
country: Japan
Study officials:
References:
citation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
Clinical trial NCT03331757: Determination of Glycemic Index of Six Greek Honey Grades
Official title: Determination of the Glycemic Index and Glycemic Load of Six Greek Honey Grades
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetitive Behavior
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Eleven healthy participants consumed in random order 50g available carbohydrates as glucose (tested three times) and 50g available carbohydrates as fir, chestnut, healther, thyme, pine, citrus, tested once, on separate occasions
Primary purpose: OTHER

Brief summary: This study determined the glycemic index and glycemic load of six Greek honey varieties

Detailed description: This randomized, double-blind, cross-over study investigated the glycemic response to six Greek honey grades differing in floral source and carbohydrate composition. Isoglucidic test meals (50g available carbohydrate) and 50g glucose reference were given to 11 clinically and metabolically healthy, fasting individuals (27±7 years; 9 women; BMI 24±4kg/m2), in random order. GI was calculated using the FAO/WHO method. Capillary blood glucose samples were collected at 0,15,30,45,60,90-and-120min. Salivary insulin samples were collected at 0,60-and-120min. Subjective appetite ratings (hunger, fullness and desire to eat) were assessed by visual analogue scales (VAS, 100mm) at baseline and 120min.

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smoking
* individuals with normal body mass index (between 18.5 and 24.9 kg/m2)

Exclusion Criteria:

* coronary heart disease
* diabetes mellitus
* kidney disease
* liver conditions
* endocrine conditions
* gastrointestinal disorders
* pregnancy
* lactation,
* competitive sports
* alcohol
* drug dependency

Primary outcomes:
measure: Capillary blood glucose responses
timeFrame: 2 hours
Secondary outcomes:
measure: Subjective appetite rating
timeFrame: 2 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
Study officials:
affiliation: Agricultural University of Athens
name: Emilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00388557: Effect of Ketoconazole on the Pharmacokinetics of Vinflunine
Official title: Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test how ketoconazole affects with handling of vinflunine by the body which might affect how much vinflunine is in the blood stream and for how long


Eligibility criteria: Inclusion Criteria:

* Advanced cancer excluding cancer within the blood, adequate kidney and liver function.

Exclusion Criteria:

* Prior use of vinflunine, other active medical disorders, severe nerve damage

Primary outcomes:
measure: To assess the effect of ketoconazole on the pharmacokinetics of vinflunine in patient with advanced cancer. A total of 28 blood samples will be collected
timeFrame: Days 1 through 5 and Day 8 of Cycles 1 and 2
Secondary outcomes:
measure: Evaluate the safety of vinflunine co-administered with ketoconazole and assess the safety of vinflunine in patients with advanced cancer. Safety laboratory assessments and evaluations will be collected
timeFrame: weekly
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology, Pllc
state: Tennessee
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03420157: Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).
Official title: Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Cervix
Keywords: Cervical cancer screening
vaginal self-sampling
Focus group
communication
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty women living near the city of Tours not screened by pap smear (ideally since at least 3 years). Women who could be interested by the vaginal self-sampling screening alternative.

Brief summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with oncogenic High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening. The investigators hypothesize that it is possible to optimize participation rate by improving the communication media associated to the vaginal self-sampling kit. This is why the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling will be submit to women opinion by using the Focus Group method. The objective is to identify improvement ideas of these two communication media.


Eligibility criteria: Inclusion Criteria:

* women from 30 to 65 years old
* women living in french territorial division 37 ("Indre-et-Loire")
* no pap smear made in the three last years (ideally)

Exclusion Criteria:

* Follow-up in progress for positive screening

Primary outcomes:
measure: Focus group methodology (structured questionnaire) will use to identify group norms or a range of views and to capitalise on the interaction within the group to identify levers and brakes and improve communication media (10 women for each focus group)
timeFrame: A systematic text analysis of the transcripts will be performed after data saturation was reached (projection: 2 focus group of 2 hours in two weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: UH Tours
state: Indre-et-Loire
Study officials:
affiliation: Centre de coordination des dépistages des cancers, CHRU de Tours
name: Julie Boyard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05845957: Digital Storytelling in Pediatric Safe Drug
Official title: The Efficiency of Education Given to Students With Digital Storytelling in Safe Pediatric Intravenous Drug Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Nursing
Innovativeness
Keywords: Nursing students
Education
Digital stroytelling
pediatrics
safe drug application
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Izmir Bakircay University
First posted: 2023-05-06
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research was a randomized controlled, experimental study.
Primary purpose: PREVENTION

Brief summary: Summary Aim: This research was conducted to determine the effectiveness of education given to students using digital storytelling in safe pediatric intravenous drug administration.

Method: It is a randomized controlled experimental study. The sample of the study consisted of 84 nursing students. The students included in the study were divided into two equal groups: the experimental and control groups. Digital education material of the experimental group and theoretical education was applied to the control group. Before and after the training, a post-knowledge test was made and evaluated.


Eligibility criteria: Inclusion Criteria:

* Being a student of the Department of Nursing
* Taking the child health and diseases nursing course and being successful
* Volunteering to participate in the research

Exclusion Criteria:

* Participate and quit the study
* Being a 1st and 2nd year nursing student
* Failure of the child health and diseases nursing course

Primary outcomes:
measure: Statistical difference between groups about knowledge test scores
timeFrame: During the education, approximately 25 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Semih
Study officials:
affiliation: Izmir Bakircay University
name: Semih Akkoyun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03479957: Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden
Official title: Remotely Monitored and Coached Exercise Based Cardiac Rehabilitation in Northern Sweden l
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Defects, Congenital
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Supervised exercise is an essential component of contemporary center-based cardiac rehabilitation (CR) programs. Despite the proven effectiveness, uptake and adherence to supervised exercise-based CR (exCR) remains suboptimal (approximately 50%), especially in rural and remote areas of Sweden. The main reasons for low participation rate in centre-based exCR are different accessibility barriers i.e. long distances, transportation problems or employment commitments. In this randomised clinical trial, the overall aim is to evaluate the effectiveness of, home-based, remotely monitored and coached exCR using the REMOTE-CR system compared to home-based exCR based on individualized information regarding current exercise recommendations but without monitoring and coaching (usual care) to improve exercise capacity. Our hypothesis is that remotely monitored and coached exCR will improve exercise capacity to a greater extent than home-based exCR without monitoring and coaching (usual care).


Eligibility criteria: Inclusion Criteria:

* Scheduled appointment with physiotherapist for follow-up after cardiac event: ----Myocardial Infarction (MI)
* Per cutaneous coronary intervention (PCI) due to MI or angina pectoris
* Open heart surgery due to coronary artery disease or valvar disease
* Living in the catchment area of Heart centre, University Hospital of Umeå.

Exclusion Criteria:

* Clinically unstable
* Postoperative infection
* Comorbidity affecting ability to participate in exCR

Primary outcomes:
measure: Change in submaximal aerobic exercise capacity
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Muscle endurance capacity
timeFrame: Baseline and 12 weeks
measure: Isometric grip strength
timeFrame: Baseline and 12 weeks
measure: Self-reported physical activity using theInternational Physical Activity Questionnaire
timeFrame: Baseline and 12 weeks
measure: Self-reported physical activity using the physical activity scale br Frändin and Grimby
timeFrame: Baseline and 12 weeks
measure: Kinesiophobia (fear of movement)
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Evaluation of change the participation rate in supervised cardiac rehabilitation
timeFrame: 12 weeks
measure: Patients experiences of REMOTE-CR and and exercise led via video link
timeFrame: 12 weeks
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Camilla Sandberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: