louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04859140: Selective Effect of Foam Rolling and Manual Massage
Official title: Effects of Self-myofascial Release and Manual Massage on Psychometric, Behavioural and Neurophysiological Indexes of Performance and Well-being: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Health, Subjective
Health Knowledge, Attitudes, Practice
Keywords: electroencephalography
electrodermal activity
flexibility
alertness
Lead sponsor: Laboratoire Interuniversitaire de Biologie de la Motricité
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three independent groups, two measurement points
Primary purpose: BASIC_SCIENCE

Brief summary: The present double-blinded randomized controlled design aims at comparing the effects of a full-body manual massage and foam rolling intervention. Sixty-five healthy individuals were randomly allocated to foam rolling, manual massage or a control intervention consisting in an autogenic relaxation routine.

Detailed description: Self-report ratings of perceived anxiety, muscle pain and relaxation were the psychometric outcome variables. Sit-and-reach, toes-touch and mental calculation performances were the behavioral variables. Resting-state alpha and beta power recorded using electroencephalography and galvanic skin resistance measures were the neurophysiological outcome variables.

Eligibility criteria: Inclusion Criteria:

* Regular practice of foam rolling (10 min routines, 2-3 times per week over the past 6 months)

Exclusion Criteria:

* Chronic medical conditions including functional limitations that might affect proprioception and/or pain perception

Primary outcomes:
measure: Change in range of motion measures from standardized flexibility tests
timeFrame: Pretest and an immediate posttest after the intervention
measure: Resting-state electroencephalography
timeFrame: Pretest and an immediate posttest after the intervention
measure: Changes in subjective scores (self-reports on numeric rating scales)
timeFrame: Pretest and an immediate posttest after the intervention
measure: Changes in mental calculation performances
timeFrame: Pretest and an immediate posttest after the intervention
measure: Changes in physiological arousal
timeFrame: Pretest and an immediate posttest after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: University Claude Bernard Lyon 1
Study officials:
References:
Clinical trial NCT03715140: Crucumin Effects on the Immune System in Osteoarthritis Patients
Official title: Evaluation of the Crucumin Effects on the Cellular and Humoral Immune Systems in Osteoarthritis Patients; a Randomised Double Blind Placebo Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Crucumin, Flowcytometry
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the effects of crucumin on cellular and humoral immune system in patients with osteoarthritis will be investigated. Concentration of CXCL8, April, CX3CL1 and IL-17 will be evaluated with ELISA. TH-1, TH-17, TReg and Ly.B cells count will be measured by Flowcytometry. MicroRNA-720, MicroRNA-155, MicroRNA-16 and MicroRNA-146a gene expression will be measured with Real Time PCR technique.

Detailed description: The purpose of this study was to evaluate the effect of the active ingredient of crucumin on the reduction of symptoms of osteoarthritis. Of the 30 patients participating in this study, a blood sample will be taken at the beginning of the study, and then after three months of taking the crucumin. To evaluate the response to treatment, after each person sampling, we will analyze cell count for Th-1, Th-17, TReg and Ly.B by flowcytomtry method. Also we will measure cytokines level of IL-17, CXCL8, CX3CL1 and April by ELISA method. Finally we evaluate the gene expression of MicroRNA-720, MicroRNA-155, MicroRNA-146a and MicroRNA-16 by Real Time PCR technique.

Eligibility criteria: Inclusion Criteria:

Osteoarthritis patients who have been diagnosed with a rheumatologist physician based on clinical examinations and laboratory tests

Exclusion Criteria:

Affected by any other acute or chronic underlying disease

Primary outcomes:
measure: IL-17
timeFrame: Baseline
Secondary outcomes:
measure: IL-17
timeFrame: Baseline and three months
measure: TH-1
timeFrame: Baseline and three months
measure: MicroRNA-720
timeFrame: Baseline and three months
measure: CXCL8
timeFrame: Baseline and three months
measure: CXCL1
timeFrame: Baseline and three months
measure: April
timeFrame: Baseline and three months
measure: TH-17
timeFrame: Baseline and three months
measure: TReg
timeFrame: Baseline and three months
measure: Ly.B
timeFrame: Baseline and three months
measure: MicroRNA-155
timeFrame: Baseline and three months
measure: MicroRNA-146a
timeFrame: Baseline and three months
measure: MicroRNA-16
timeFrame: Baseline and three months
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mahdi Atabaki
Study officials:
affiliation: Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
name: Mojgan Mohammadi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00202540: Efficacy and Safety of S18986 in the Treatment of Mild Cognitive Impairment Patients
Official title: Efficacy of 15 mg and 50 mg of S18986 on Cognitive Symptoms in Mild Cognitive Impairment Patients Treated Over a 12-month Oral Administration Period
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 38
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to demonstrate a long term efficacy of S18986 versus placebo on episodic memory performance in patients with MCI


Eligibility criteria: Inclusion Criteria:

* Memory complaint
* Acetylcholinesterase inhibitors stopped at least 3 months before selection

Exclusion Criteria:

* Dementia
* Parkinson's disease
* Vascular disorder
* Depression
* Epilepsy

Primary outcomes:
measure: Episodic memory
Secondary outcomes:
measure: Other cognitive domains, activities of daily living, global impression of change, MRI, safety.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital la Grave-Casselardit
Study officials:
affiliation: Hôpital la Grave-Casselardit, Toulouse
name: Bruno Vellas, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01830140: A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 466
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: This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of glaucoma or ocular hypertension

Exclusion Criteria:

* Active ocular disease other than glaucoma or ocular hypertension
* Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)

Primary outcomes:
measure: Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
timeFrame: Baseline, 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: El Paso
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05873140: Healthy Thai Project With Bangkoknoi Model: Fatless Community
Official title: Healthy Thai Project With Bangkoknoi Model: Fatless Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to make people in a community realize negative effects of obesity on health, and how to tackle it by adopting a lifestyle modification for weight reduction. Adults aged 20 years old or more with obesity (BMI ≥ 25 kg/m2) or waist circumference ≥ 80 cm in women and ≥ 90 cm in men were recruited. All participants received an educational session of lifestyle modification for weight reduction on the first day of study. Participants were then assigned to either continuously receive education (video clips and infographics) via application LINE, or no further education. The main questions it aims to answer are:

1. Whether or not an educational session of lifestyle modification leads to weight reduction.
2. Whether or not a weight loss by a continuous education via an online application is more effective than not receiving it.


Eligibility criteria: Inclusion Criteria:

* Obesity (BMI ≥ 25 kg/m2)
* Waist circumference ≥ 80 cm in women and ≥ 90 cm in men

Exclusion Criteria:

* Contraindications for bioelectrical impedance analysis
* Active cancer
* No available health data

Primary outcomes:
measure: Body weight change
timeFrame: 6 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Phunchai Charatcharoenwitthaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03592940: The Management of Neuroendocrine Tumours: A Nutritional Viewpoint.
Official title: Association Between Mediterranean Diet and Neuroendocrine Tumours.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mediterranean Diet
Neuroendocrine Tumours (NETs)
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: One hundred patients with neuroendocrine tumours (NETs) were consecutively enrolled (aged 18-60 years) in this cross-sectional observational study. Anthropometric measures were evaluated. A validated 14-item questionnaire PREDIMED (PREvención con DIeta MEDiterránea) was used for the assessment of adherence to the MD. Dietary data were collected by a 7-day food records.

Brief summary: Nutritional status in patients with neuroendocrine tumours (NETs), especially of gastroenteropancreatic origin, can be deeply affected by excessive production of gastrointestinal hormones, peptides, and amines, which can lead to malabsorption, diarrhoea, steatorrhea, and altered gastrointestinal motility. Besides, the surgical and/or medical management of NETs can lead to alteration of gastrointestinal secretory, motor, and absorptive functions, with both dietary and nutritional consequences. Indeed, disease-related malnutrition is a frequently encountered yet both underrecognized and understudied clinical phenomenon in patients with NETs, with substantial prognostic and socioeconomic consequences. Most of these conditions can be alleviated by a tailored nutritional approach, also with the aim of improving the efficacy of cancer treatments. In this setting, skilled nutritionists can play a fundamental role in the multidisciplinary health care team in NETs management and their presence should be recommended.


Eligibility criteria: Inclusion Criteria:

* patients with neuroendocrine tumours (NETs)

Exclusion Criteria:

* age\>65 years
* \< BMI 19 kg/m2
* vegetarians

Primary outcomes:
measure: Adherence to Mediterranean Diet by Predimed Questionnaire
timeFrame: December 2017 to June 2018
Secondary outcomes:
measure: Body composition
timeFrame: December 2017 to June 2018
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Silvia Savastano
Study officials:
References:
Clinical trial NCT03156140: Pulse Oximeter Motion Study
Official title: Four Types of Pulse Oximeters Accurately Detect Hypoxia During Low Perfusion and Motion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three motions compared to non-motion control at three arterial oxygen saturation target plateaus.

Detailed description: Evaluate the performance of 4 pulse oximeters (Masimo Radical-7, Nihon-Koden OxyPal Neo, Nellcor N-600, and Philips Intellivue MP5) in 10 healthy adult volunteers. Three motions will be evaluated: tapping, pseudorandom, and volunteer-generated rubbing, adjusted to produce photoplethsmogram disturbance similar to arterial pulsation amplitude. During motion, inspired gases will be adjusted to achieve stable target plateaus of arterial oxygen saturation (SaO2) at 75%, 88%, and 100%. Pulse oximeter readings (SpO2) will be compared with SaO2 from simultaneous arterial blood samples

Eligibility criteria: Inclusion Criteria: healthy adult English speaking -

Exclusion Criteria: pediatric, cardiac or pulmonary condition. non-english speaking

-

Primary outcomes:
measure: Pulse oximetry reading
timeFrame: immediate
Secondary outcomes:
measure: Arterial Blood gas
timeFrame: immediate
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01707940: Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers
Official title: Relative Bioavailability of a Single Oral Dose of BI 144807 (Oral Solution) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Tablet) in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.


Eligibility criteria: Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
timeFrame: 0 to 48 hours after administration
measure: Maximum measured concentration of the analyte in plasma
timeFrame: 0 to 48 hours after administration
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point
timeFrame: 0 to 48 hours after administration
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1313.7.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04141540: Molecular Variants Associated With Schizophrenia: Differential Analysis of Monozygotic Twins With Variable Phenotypic 22q11
Official title: Translational 22q11.2:"Molecular Variants Associated With Schizophrenia: Differential Analysis of Monozygotic Twins With Variable Phenotypic 22q11.2 Microdeletional Syndrom"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Di George Syndrome
Keywords: 22q11.2 Microdeletional
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It's a study with a comparative monocentric cross-sectional analysis model.
Primary purpose: DIAGNOSTIC

Brief summary: The 22q11.2 microdeletion syndrome (22q11.2DS) is a rare disease with a psychiatric phenotype. Indeed, the diagnosis of schizophrenia is made in 5 to 10% of adolescents and 25 to 40% of adults carrying the 22q11DS. Thus, although this pathology has been able to provide a genetically homogeneous model for the study psychosis etiology, it is not currently possible to establish a link between genomic rearrangement and psychotic symptoms. However, this robust model of genetic vulnerability could provide us a lot of translational informations about schizophrenia genetics. To go furthermore, twin studies have provided us precious data for the study of hereditary diseases. Combining this two approaches, the translational 22q11.2 project proposes a molecular study of two monozygotic 22q11.2DS twins discordant for the psychiatric phenotype -one carrying schizophrenia and the other having no psychiatric symptoms-.

Detailed description: The main objective of the study is to propose a whole exome sequencing (WES), pan-genomic in whole genome sequencing (WGS), transcriptomic, epigenomic and intestinal microbiome approaches in order to determine specific molecular basis of psychotic symptoms in 22q11.2DS.

Eligibility criteria: Inclusion Criteria:

* • Sisterhood of monozygotic twins diagnosed with de novo 22q11.2DS is confirmed by CGH array and discordant for the psychiatric phenotype

Exclusion Criteria:

* • Refusal to use data for research purposes

Primary outcomes:
measure: Whole exome sequencing
timeFrame: 6 months
Secondary outcomes:
measure: Transcriptome
timeFrame: 6 months
measure: Methylome
timeFrame: 6 months
measure: Microbiotic DNA
timeFrame: 6 months
measure: Positive And Negative Syndrome Scale (PANSS)
timeFrame: 6 months
measure: Mini-International Neuropsychiatric Interview (MINI)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Vinatier
state: Rhone Alpes
Study officials:
affiliation: Centre Hospitalier le Vinatier & CNRS UMR 5229 (BRON, France)
name: DEMILY CAROLINE, MD PH.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01182740: Comparison of Endotracheal Intubation Success Rates Using Video Laryngoscopes in Entrapped Patients - a Manikin Study
Official title: Comparison of Endotracheal Intubation Success Rates Using Video Laryngoscopes in Entrapped Patients - a Manikin Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Intubation
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: experienced emergency physicians

Brief summary: The investigators will compare the success rates of endotracheal intubation in a simulated entrapped car accident victim (manikin) using different video laryngoscopes by experienced emergency physicians.

The investigators hypothesized that video laryngoscopes may improve success rates.


Eligibility criteria: Inclusion Criteria:

* experienced emergency physicians

Exclusion Criteria:

* no experience in out-of-hospital emergency medicine

Primary outcomes:
measure: successful endotracheal intubation
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
References:
citation: Wetsch WA, Carlitscheck M, Spelten O, Teschendorf P, Hellmich M, Genzwurker HV, Hinkelbein J. Success rates and endotracheal tube insertion times of experienced emergency physicians using five video laryngoscopes: a randomised trial in a simulated trapped car accident victim. Eur J Anaesthesiol. 2011 Dec;28(12):849-58. doi: 10.1097/EJA.0b013e32834c7c7f.
Clinical trial NCT03368040: Comparison Between Non-invasive Heat-flux and Invasive Core Temperature Monitoring
Official title: Comparison Between Tcore(TM) Temperature Monitoring System and Invasive Blood Temperature Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Temperature Changes
Keywords: body core temperature
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that undergo major abdominal surgery

Brief summary: The body core temperature drops during general anesthesia. To maintain homeostasis, patients require warming measures. Different methods to measure body core temperature exist, which are either highly accurate but invasive, or non-invasive but non-accurate. A new monitoring device, Tcore(TM), enables a non-invasive but accurate core temperature assessment.

This study is performed to quantify accuracy and bias of the Tcore system in comparison with the blood temperature, which is the gold standard of core temperature measurement.


Eligibility criteria: Inclusion Criteria:

* Patients with invasive femoral artery temperature monitoring

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Bias of heat-flux temperature monitoring [%]
timeFrame: from insertion of thermometers to end of surgery
Secondary outcomes:
measure: Inaccuracy of heat-flux temperature monitoring [%]
timeFrame: from insertion of thermometers to end of surgery
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Study officials:
References: