louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06139237: Factors That Determine the Responses to Food Ingestion: Protein Load
Official title: Factores Que Determinan la Respuesta a la Ingesta: Efecto de la Carga Proteica
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: meal ingestion
meal composition
postprandial responses
hedonic sensations
homeostatic sensations
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Aim: to determine to what extent meal composition influences postprandial sensations. Experimental design: randomized cross-ower study comparing the responses to a high protein (47.3% protein, 39.4% carbohydrates, 13.3% lipids) versus a balanced (22.2% protein, 67.85% carbohydrates, 9.95% lipids). In each participant the meals (both containing 20.8 g protein and diluted to a volume of 200 mL) will be tested on separate days. Healthy, non-obese participants (8 men and 8 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion, at 10 min intervals up to 60 min after the meal and at 30 min up to 120 min after ingestion. Blood samples for biochemical and hormonal determinations will be taken before and after ingestion.


Eligibility criteria: Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Change in digestive well-being measured after the test meal
timeFrame: 1 day
Secondary outcomes:
measure: Change in satiety measured after the test meal
timeFrame: 1 day
measure: Change in fullness sensation measured after the test meal
timeFrame: 1 day
measure: Change in abdominal discomfort/pain sensation measured after the test meal
timeFrame: 1 day
measure: Change in mood measured after the test meal
timeFrame: 1 day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
Study officials:
References:
Clinical trial NCT05785637: Polygraphy at Home for Neuromuscular Patients Under Non-invasive Mechanical Ventilation
Official title: Initiation of Polygraphy for Neuromuscular Disease Patients Under Non-invasive Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromuscular Diseases
Keywords: Neuromuscular Diseases
Polygraphy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Association Française contre les Myopathies (AFM), Paris
First posted: 2023-03-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic respiratory failure due to neuromuscular diseases under non-invasive mechanical ventilation

Brief summary: The primary objective of the study is to evaluate the feasibility, the quality and the utility of a polygraphic control at home in order to appreciate the efficacy of the night time non-invasive ventilation (allowing to optimize the ventilator settings when the results are not satisfactory).


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years;
* Patient with chronic respiratory insufficiency has just been posed non-invasive ventilation (NIV) in the hospital, according to the latest international recommendations ;
* Affiliation to the social security scheme;
* Patient has signed the informed consent form to participate to the study.

Exclusion Criteria:

* Patient refusal;
* Patient under guardianship;
* Patient under AME scheme;
* Patients living more than 40 km from reference center;
* Patient depending on mechanical ventilation (more than 6 hours daily);
* Rapidly or reversible evolutive neuro-myopathy (Amyotrophic lateral sclerosis, Guillain Barré syndrome, myasthenia).

Primary outcomes:
measure: Gradation of quality of recorded signals at home
timeFrame: at day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP
Study officials:
affiliation: Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP
name: Frédéric Lofaso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of physiology and functional explorations - Raymond Poincaré Hospital - APHP
name: Hélène Prigent, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01951937: Fish Intervention and Learning Abilities
Official title: Fish Intervention and Learning Abilities in German Youths
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Enhancement
Keywords: Cognitive Test
Omega-3 Fatty acids
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: National Institute of Nutrition and Seafood Research, Norway
First posted: 2013-09-27
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the FINS study we test - in a randomized non blinded intervention study- the hypothesis that increased intake of salmon will improve cognitive performance of children aged 4 years to 6 years in the Munich area (Germany), who habitually consume little fish.

Detailed description: Long chain polyunsaturated fatty acids (LC-PUFA) of the n-3 series, eicosapentaenoic acid (EPA) and most prominently docosahexaenoic acid (DHA), are considered important for neural development during pre- and postnatal development.

Eligibility criteria: Inclusion Criteria:

* 4-6 years

Exclusion Criteria:

* severe illness
* child dislikes fish

Primary outcomes:
measure: Change in Cognitive Performance
timeFrame: Change from baseline at 4 months later
Secondary outcomes:
measure: Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage
timeFrame: Change from baseline at 4 months later
measure: Change of red blood cell fatty acids (omega-3 index),plasma phospholipid species and plasma vitamin D3
timeFrame: Change from baseline at 4 months later
measure: Change of iodine levels in urine
timeFrame: Change from baseline at 4 months later
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre
state: Bavaria
Study officials:
affiliation: Head, Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre - Klinikum d. Univ. München Lindwurmstr. 4, D-80337 Muenchen, Germany
name: Berthold Koletzko, Dr med habil
role: STUDY_DIRECTOR
References:
citation: Demmelmair H, Oyen J, Pickert T, Rauh-Pfeiffer A, Stormark KM, Graff IE, Lie O, Kjellevold M, Koletzko B. The effect of Atlantic salmon consumption on the cognitive performance of preschool children - A randomized controlled trial. Clin Nutr. 2019 Dec;38(6):2558-2568. doi: 10.1016/j.clnu.2018.11.031. Epub 2018 Dec 22.
Clinical trial NCT03049137: Computer Guided Versus Conventional Augmentation Using Bone Ring
Official title: Evaluation of Computer-Guided Versus Conventional Simultaneous Implant Placement With Ridge Augmentation Using an Autogenous Bone Ring Graft With PRF on Patient's Esthetic Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using bone ring grafts with simultaneous implant placement after three-dimensional augmentation of severely defective bone ridges using computer-guided surgical templates. The study compares accuracy effectiveness by mimics software

Detailed description: To study the effectiveness of computer guided surgical stents in ridge augmentation with implant insertion compared with free hand augmentation

-Population/Intervention/Comparator/Outcome (PICO)-

Population (P): patients with massive bone resorption horizontally and vertically, severe bone loss around teeth, periodontal disease or traumatic extraction in partially edentulous maxillary anterior region requiring implant insertion.

Intervention (I): simultaneous implant placement with ridge augmentation using computer guided surgical templates with PRF.

Comparator (C): Free hand simultaneous implant placement with ridge augmentation.

Outcome (O): Patient esthetic satisfaction - Augmentation and implant insertion accuracy

Eligibility criteria: Inclusion Criteria:

1. Patients with insufficient alveolar ridge or severe alveolar bone resorption horizontally and vertically in partially edentulous maxillary anterior region.
2. Medically free patients in order to be a confounding factor on the final results.
3. Highly motivated patients.
4. Good oral hygiene.
5. Patients physically able to tolerate surgical and restorative procedures.

Exclusion Criteria:

1. Young patients (incomplete bone growth).
2. Patients with any systemic disease that could affect bone healing.
3. Patients allergic to local anaesthetic agent.
4. Pregnant or lactating females.
5. Presence of any pathosis in the area.
6. history of oral radiotherapy.
7. history of prolonged steroid use.
8. Psychological disorders.

Primary outcomes:
measure: Patient Satisfaction regarding esthetic results.
timeFrame: 5 month
Secondary outcomes:
measure: Accuracy of computer guided surgical templates in comparison with 3D virtual planning.
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
state: Cairo
Study officials:
References:
citation: Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.
Clinical trial NCT05153837: Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers
Official title: Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Fluids
Pharmacodynamics
Fluid Therapy
Fluid Responsiveness
Fluid Challenge
Keywords: intravenous fluids
pharmacodynamics
fluid therapy
fluid responsiveness
fluid challenge
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Human digestive system physiologically ensures the absorption of oral water and hydration of the human body. Water is quickly absorbed by the digestive tract with a peak between 15 and 20 minutes. It has demonstrated that oral water remains the best hydration solution that have an effect on plasma volume expansion and cardiovascular system during exercise. While the cardiovascular effect of fluid expansion by saline serum is well known (venous return, preload and cardiac output), effect of oral water varies in the literature depending on the physiological state of the patient and the clinical state. Thus, the investigators aim to investigate oral water effects on fluid responsiveness, regional blood flow and microcirculatory changes.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer subject between 18 and 30 years old
* patient with a regular sinus rhythm
* Echogenic subject.
* Fasting of solid and liquid since 8 h
* Subject in regular sinus rhythm.
* Written consent signed.

Exclusion Criteria:

* Any known cardiac, renal or endocrine pathology.
* Arrhythmia rhythm disorder by atrial fibrillation
* Pregnant or nursing woman.
* Pathology versus indicating Nacl administration.
* Person under tutors or curators or deprived of liberty.
* Person not affiliated to a social security scheme.

Primary outcomes:
measure: number of fluid responders 30 minutes after fluid expansion
timeFrame: 30 minutes after fluid expansion
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT01218737: Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
Official title: Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Infection and Inflammation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2010-10-11
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops in the prevention of infection and inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0% prednisolone acetate as isolated eye drops formulations. The study treatment is randomized, double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days of study treatment administration after the ocular surgery is performed. Candidates for the study are patients with indication for ocular refractive surgery (Lasik) for correction of visual acuity.


Eligibility criteria: Inclusion Criteria:

* Patient is indicated to have an ocular refractive surgery performed (myopia, astigmatism, hypermetropy) by the Lasik method.
* Patient presents a normal eye fundus.
* Patient has intraocular pressure (IOP) ≤ 20 mmHg.

Exclusion Criteria:

* Surgery and/or previous ocular pathology (presence of scar/change in the cornea, glaucoma, retinopathies, etc.).
* Patient has diabetes or is immunodepressed.
* Any systemic infection during the study.
* Signs and/or symptoms of ocular inflammation/infection (bacterial, viral, fungal, caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology).
* Have used any systemic or topical antibiotics for ocular infection in the previous 14 days.
* Patient has known hypersensitivity to any of the components of the formulations used in the study.

Primary outcomes:
measure: Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo - Dept of Ophthalmology
state: SP
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03730337: Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Official title: Open-label, Uncontrolled, Dose-escalation Study of ONO-7475 Given as Monotherapy and Combinations With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2018-11-05
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors


Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
* ECOG Performance Status 0～1
* Patients with life expectancy of at least 3 months

Exclusion Criteria:

* Patients with history of severe allergy
* Patients with multiple cancers

Primary outcomes:
measure: Number of paticipants with dose-limiting toxicities during the DLT evaluation period
timeFrame: 28 days
measure: Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Pharmacokinetics (Cmax)
timeFrame: Through study completion
measure: Pharmacokinetics (Tmax)
timeFrame: Through study completion
measure: Pharmacokinetics (AUC)
timeFrame: Through study completion
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo Clinical Site
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT03608137: Cannabis and Thought Disorder in Schizophrenia
Official title: Cannabis and Thought Disorder in Schizophrenia: Clinical and Neuroimaging Relationships
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia ; Cannabis
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Recent studies have suggested a strong relationship between cannabis use and the level of thought disorder in subjects with schizophrenia. Moreover, the level of thought disorder has been associated with an increased functional connectivity between the temporal lobe and the Putamen. However, the brain mechanisms underlying these two relationships are still poorly known. Better understanding these mechanisms is important to improve patients' care, in particular among treatment-resistant patients.

The objective of the CANDI study consists of assessing whether the level of cannabis use in patients with schizophrenia modulates the level of thought disorder via a modulation of the functional connectivity between the temporal lobe and the Putamen. Analyses will be controlled for the composition of cannabis, in particular the tetrahydrocannabinol / cannabidiol ratio.

Detailed description: 25 subjects with schizophrenia and current cannabis use will be recruited in the experimental group. The control group will consist of 25 subjects with schizophrenia but with no cannabis use.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65
* Meeting the DSM-5 criteria for schizophrenia
* "Cannabis user" group: - Smoking at least two days per week during the previous months
* Displaying positive urine screen for cannabis
* "Non-cannabis user" group: - No episode of cannabis smoking during the previous month
* Negative urine screen for cannabis + no lifetime criteria for cannabis use disorder (assessment by an addiction specialist).

Exclusion Criteria:

* Current criteria for axis-1 psychiatric disorder other than schizophrenia
* Current criteria for any other substance use disorder except for nicotine use disorder
* Any contraindication for MRI
* Tutorship or curatorship
* Pregnant or lactating woman

Primary outcomes:
measure: Level of thought disorder
timeFrame: one year
Secondary outcomes:
measure: cannabis use
timeFrame: one year
measure: Delta-9 tetrahydrocannabinol (THC) concentration
timeFrame: one year
measure: Cannabidiol (CBD) concentration
timeFrame: one year
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier
state: Auvergne Rhone Alpes
Study officials:
affiliation: CH LE VINATIER
name: Benjamin ROLLAND, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH LE VINATIER
name: Guillaume SESCOUSSE, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04498637: Attitudes Towards Disability of Nursing and Physiotherapy Students
Official title: Attitudes Towards Disability of Nursing and Physiotherapy Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disability Physical
Disabilities Multiple
Disability Hearing
Disability, Vision
Disability, Intellectual
Keywords: Physiotherapy students
Nursing students
Disability
Attitude
Lead sponsor: University of Extremadura
Sponsor class: OTHER
Collaborators: name: University of Cadiz
First posted: 2020-08-04
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students enrolled in the Physiotherapy or Nursing Bachelor´s Degree of the University of Cadiz during the academic year of 2017/2018

Brief summary: The general objective of this study is to know the attitude towards people with disability of Nursing and Physiotherapy students in the University of Cadiz. This is a descriptive, correlational, transversal and synchronous study.

Detailed description: Attitudes determine our behaviour to some extent. Health professionals should have a global perspective of disability. They must provide treatment to people with disability and care for them, but also should accept them with no judgements or discrimination. The general objective of this study is to know the attitude towards people with disability of Nursing and Physiotherapy students in the University of Cadiz. Method: This is a descriptive, correlational, transversal and synchronous study. A total of 200 students participate in the study (91 from the Bachelor's Degree in Nursing and 109 from the Bachelor's Degree in Physiotherapy). The 'Attitudes towards people with disability Scale' was used.

Eligibility criteria: Inclusion Criteria:

* Students from the Physiotherapy Bachelor´s Degree of the university of Cadiz
* Students from the Nursing Bachelor´s Degree of the university of Cadiz, Campus of Jerez de la Frontera and Cadiz

Exclusion Criteria:

* None

Primary outcomes:
measure: Attitude towards disability
timeFrame: Through study completion, an average of 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: University of Cadiz
Study officials:
References: