louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02760446: Translation and Validation of the French Version of Confusion Assessment Method for the Intensive Care Unit
Official title: Validation of the French Confusion Assessment Method for the Intensive Care Unit Among Adult ICU Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Mental Confusion
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2016-05-03
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Validity and Reliability of French Version of the Confusion Assessment Method for the Intensive Care Unit (psychometric validation study after translation/back translation process assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)


Eligibility criteria: Inclusion Criteria:

* Adult, \> or equal to 18-yr
* Richmond Agitation Sedation Scale (RASS) \> or equal -3
* Francophone

Exclusion Criteria:

* Diagnostic of cognitive disorders
* Admission for brain injury
* Psychotic disorders
* Diagnostic of cognitive disorders
* Visual or auditory impairments

Primary outcomes:
measure: Statistical criteria of performance (sensibility, specificity, negative predictive value, positive predictive value) of Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) compared to gold standard (neuropsychologist).
timeFrame: Day 0
Secondary outcomes:
measure: Inter-rater reliability, comparison to Intensive Care Delirium Screening Checklist and standard bedside practices
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire Montpellier, Saint Eloi
state: Languedoc-Roussillon
Study officials:
affiliation: University of Montpellier Hospitals
name: GERALD CHANQUES, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142946: Quantified Balance Measures During Stance and Gait: Multiple Sclerosis Patients. A Longitudinal Clinical Study
Official title: Quantified Balance Measures During Stance and Gait: Clinical Relevance for Multiple Sclerosis Patients in Comparison to Patients With Inner Ear Balance Problems. A Longitudinal Clinical Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Balance Control
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MS or UVL

Brief summary: The primary objective of this project is to track changes over time in balance control parameters measured during stance and gait for different groups of multiple sclerosis (MS) patients. Our primary goal is to determine whether these changes in balance control over time predict transitions in MS progression to a more disease affected state, and are different from changes over time for patients with balance deficits due to vestibular sensory disorders. A part of this goal is also to determine whether these changes in balance control are correlated with changes in patients' self-reported deficits and are similar to those changes in balance control of patients with peripheral vestibular loss. The secondary objective is to determine for multiple sclerosis (MS) patients the relationship of their balance parameters to different gait speeds, in order to advise them on, and promote via feedback, safe walking speeds. Fulfilling the first of our objectives would lead to better tracking of MS disease changes over time, earlier quantification of onset of symptoms suggesting a worsening of disease status, and, we assume, greater patient satisfaction knowing that quantification of symptoms fits subjective feelings of balance deficits during stance and gait. Achieving the second objective would lead to improved balance during gait. We aim to carry out these objectives using equipment (SwayStar) which we have proven is sensitive to MS induced balance deficits {2}, but costs far less to operate and maintain than previously used quantification tools. We aim to investigate the balance deficits during gait in different MS patient groups using a multimodal approach with a SwayStar system (analysis of balance during stance and gait in terms of trunk-pelvis movements near the centre of mass) and patient questionnaires.


Eligibility criteria: Inclusion Criteria:

* Balance deficits due to inner ear disease or MS

Exclusion Criteria:

* Inability to walk without a walking aid

Primary outcomes:
measure: Change in balance during stance and gait
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Lab for Exp Otoneurology, University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: John HJ Allum, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00289146: Comparison of Immune Response Following Surgical Management of Renal Tumors
Official title: Comparison of Immune Response Following Surgical Management of Renal Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Cancer
Keywords: kidney cancer, immunology
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2006-02-09
Enrollment: 50
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 undergoing open or laparoscopic surgeries for the treatment of kidney tumors.

Brief summary: Examine the effects of renal surgery on the immune system.

Detailed description: Prospective study examining the effects of different surgical procedures on immune function. This may have bearing on overall cancer specific recurrence and survival.

Eligibility criteria: Inclusion Criteria:

* Kidney tumor patients scheduled for open or laparoscopic surgery

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Kenneth Ogan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06302946: Effect of Neuromuscular Stimulation and Mindfulness Breathing in Patients With Stroke
Official title: Effect of Neuromuscular Stimulation and Mindfulness Breathing on Pulmonary, Physical Functions and Stress in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is an interventional study in which 60 stroke patients were estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation and mindfulness breathing, while the control group will receive neuromuscular stimulation only.

Detailed description: It is an interventional study in which 60 stroke patients will be estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation and mindfulness breathing, while the control group will receive neuromuscular stimulation only. The experimental group participants will receive neuromuscular electrical stimulation that will last 12 consecutive weeks, three sessions per week protocol with Mindful breathing is a mindfulness exercise that involves using breathing as an object of attention.

Eligibility criteria: Inclusion Criteria:

* The subject selection will be according to the following criteria:
* All Patients of this study will be diagnosed as stroke and the diagnosis will be confirmed by computed tomography or MRI (El-Tamawy et al., 2021).
* Age of patients will be ranged from 50 to 65years (males and females).
* All patients will be hemodynamically stable.
* Patients with good cognition that enables them to understand the requirements of the study.

Exclusion Criteria:

* • The potential participants will be excluded if they meet one of the following criteria:

  * Patients who cannot follow instructions as sensory aphasia, blindness, dementia, and deafness.
  * Patients with any orthopedic, neurological, or chest disorders that affect trunk muscles control or cause respiratory disorders as COPD.
  * Patients with cognitive and psychiatric disorders.
  * Patients with unstable cardiovascular conditions.
  * Patients with contraindications to neuro electrical stimulation as:
  * Cardiac pace maker.
  * Acute abdominal surgery.

Primary outcomes:
measure: ventilatory function
timeFrame: 12 weeks
Secondary outcomes:
measure: level of stress
timeFrame: 12 weeks
measure: Functional independence measure
timeFrame: 12 weeks
measure: level of physical function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
state: Dokki
Study officials:
affiliation: Cairo University
name: marwa elsayed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02812446: Staphylokinase and ABO Group Phenotype: New Players in Staphylococcus Aureus Implant-associated Infections Development
Official title: Staphylokinase and ABO Group Phenotype: New Players in Staphylococcus Aureus Implant-associated Infections Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcal Infection
Keywords: biofilm
staphylokinase
Staphylococcus aureus
microarrays
bone binding sialoprotein
bone and joint infection
blood group
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty-five IAI patients were included; two of them had two different S. aureus IAI episodes. The median age was 73 years (range: 21-96 years) with 29 women (52.7%). Twenty seven percent of patients suffered from diabetes and were smokers.

Nine patients including six women were immunosuppressed with a median age of 71 years. The main diagnosis for arthroplasty was arthrosis (38%). Implants were hip prosthesis (n = 35), knee prosthesis (n = 18) and osteosynthesis (n = 4). Main local consequences of IAI were scarce alteration (n = 34) and skin fistulization (n = 22). These IAI were treated by surgical removal of all infected tissue and implant or a combination of debridement with implant retention associated to long-term antimicrobial therapy active against biofilm microorganisms. Eighteen early, nine delayed and 30 late infections occurred. Blood group phenotypes were available for 54 patients and were distributed as follows: 26 O group, 17 A group, 10 B group and one AB group.

Brief summary: The purpose of this study is to identify bacterial and/or clinical features involved in the pathogenesis of Staphylococcus aureus implant-associated infections (IAI). Materials \& methods: In total, 57 IAI S. aureus and 31 nasal carriage (NC) S. aureus isolates were studied. Staphylococcus aureus genetic background was obtained by microarray analysis. Multilocus sequence typing was performed to determine clonal complexes (CC). Biofilm production was investigated by resazurin and crystal violet methods


Eligibility criteria: Inclusion Criteria:

* infected patients with S. Aureus IAI infection
* noninfected patients screened for S. aureus nasal colonization at the orthopedic consultation ward

Exclusion Criteria:

* minor

Primary outcomes:
measure: biofilm production measurement in the two groups
timeFrame: september 2012
measure: Clonal complexes distribution
timeFrame: september 2012
measure: IAI and NC nasal carriage isolates genetic background
timeFrame: september 2012
Secondary outcomes:
measure: biofilm production correlation with genotype
timeFrame: december 2013
measure: Correlation between Clonal Complexes distribution , genotype and clinical parameters
timeFrame: december 2013
measure: Association of ABO group phenotype and IAI S. aureus genotype
timeFrame: december 2013
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00698412: Effectiveness of Cane in Osteoarthritis (OA) Patients
Official title: The Impact of Daily Cane Use on Pain, Function, Quality of Life and Energy Consumption During the Gait in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Daily cane use
Pain
Function
Quality of life
Energy consumption during the gait
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2008-06-17
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty four participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of daily cane use on pain, function, quality of life and energy consumption during the gait in patients with knee osteoarthritis.

Detailed description: Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study

Eligibility criteria: Inclusion Criteria:

* Primary Knee osteoarthritis (ACR criteria)
* VAS for knee pain between 3 and 7
* No changes the NSAID intake or physical activity in the previous 3 months

Exclusion Criteria:

* Symptomatic heart or pulmonary disease
* Severe systemic disease
* Other symptomatic disease in the lower limb or in the upper limb that will carry the cane
* Joint injection in the previous 3 months
* PT in the previous 3 months
* Previously cane use
* Start regular physical activity in the last month

Primary outcomes:
measure: Pain - visual analogue scale
timeFrame: T0, T30 and T60
Secondary outcomes:
measure: Function - Lequesne index
timeFrame: T0, T30 and T60
measure: Function - WOMAC questionnaire
timeFrame: T0,T30 and T60
measure: Quality of life - SF-36
timeFrame: T0, T30 and T60
measure: Energy consumption (VO2)- gas analysis with and without cane during the 6MWT
timeFrame: T0, T30 and T60
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Anamaria Jones, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Jamil Natour, MD
role: STUDY_CHAIR
References:
citation: Jones A, Silva PG, Silva AC, Colucci M, Tuffanin A, Jardim JR, Natour J. Impact of cane use on pain, function, general health and energy expenditure during gait in patients with knee osteoarthritis: a randomised controlled trial. Ann Rheum Dis. 2012 Feb;71(2):172-9. doi: 10.1136/ard.2010.140178. Epub 2011 Nov 29.
Clinical trial NCT05416112: Non-invasive Left Ventricle Contractility dp/dt as Prognostic Marker in Chest Unit Patients
Official title: Non Invasive Left Ventricle Contractility dp/dt Could be Used as a Prognostic Marker in Patients Admitted to the Emergency Department for Chest Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chest Pain
Keywords: chest pain,
myocardial ischemia,
acute myocardial dysfunction,
plethysmography,
non invasive dp/dt.
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 500
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 presenting to the emergency department with acute chest pain

Brief summary: Ischemic heart disease is a major public health problem with high mortality rate despite the progress in management and the resources mobilized. The idea is that myocardial ischemia is generally associated with left ventricular dysfunction and, consequently, a possible alteration of the dp/dt index. As dp/dt could be assessed non-invasively by plethysmographic method, it is interesting to investigate its prognostic performance in patients with indifferentiate chest pain.

Detailed description: Ischemic heart disease remains a major public health problem. Despite all the advances in the prognostic approach to ischemic heart disease, the risk of occurrence of major cardiovascular events is not negligible. Several scores have been proposed for chest pain stratification risk, the most widely used are the TIMI and the GRACE scores.

The dP/dt max is therefore an excellent index of contractility, corresponding to the maximum level of tension developed by an isolated cardiac muscle during the isovolumic contraction phase.

the investigator theorized that a less value of dp/dt would be associated with more major cardiovascular events (MACE), because ischemia reduces myocardial contractility.

The current study describes non-invasive plethysmographic dp/dt changes, which could be used as a prognostic marker in patients presenting at the emergency department with acute chest pain.

Eligibility criteria: Inclusion criteria:

* age over 18 years old,
* acute chest pain

Exclusion criteria:

* traumatic chest pain,
* hemodynamic instability;
* arrhythmias;
* holders of a pacemaker;
* STEMI

Primary outcomes:
measure: MACE
timeFrame: one month
measure: MACE
timeFrame: SIX MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency Departement
Study officials:
affiliation: Monastir University Hospital, Monastir, Tunisia, 5000
name: Nouira Semir, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06218212: The Effect of Renastart Formula Supplementation in Children With Acute Kidney Injury in Maintaining Normal Serum Electrolytes Levels
Official title: The Effect of Renastart Formula Supplementation on Serum Electrolytes in Children With Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial will evaluate Renastart formula effectiveness in children with acute kidney injury (AKI) and acute on top of chronic kidney disease (CKD), in maintaining normal serum electrolytes levels without using electrolyte binders,24 patients will be recruited from Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University, they will be assigned randomly in to two arms, arm 1 including patients who will be treated by electrolytes binders, arm 2 including patients who will be treated by Renastart formula, after initial assessment serum electrolyte evaluation will be followed up monthly for 3 months.


Eligibility criteria: Inclusion Criteria:

•Infants and Children with AKI and acute on top of CKD Suffering from hyperkalemia and/or hyperphosphatemia at Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University Hospitals.

Exclusion Criteria:

* Patients are on dialysis.
* Pediatric patients with coexisting another medical problems and different risk factors which can affect serum electrolytes such as: Constipation, high volume blood transfusion and Diabetes medications disrupt potassium balance e.g., ACEI, ARBS and Diuretics.

Primary outcomes:
measure: To evaluate the effectiveness and tolerability of Renastart formula in children with AKI and acute on top of CKD to correct and maintain normal serum levels of electrolytes.
timeFrame: monthly for 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine-Ain Shams University
state: Abbasia
Study officials:
affiliation: lecturer of pediatrics,Faculty of Medicine, Ain shams University
name: Haya E Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05088512: The Role of Genetic Factors in the Development of Bronchial Asthma in the Kazakh Population
Official title: Preventive and Personalized Medicine (2021-2023)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Genome Wide Association Studies
Keywords: Bronchial Asthma
Genome Wide Association Studies
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with bronchial asthma confirmed by a doctor

Brief summary: To research for a genetic marker of bronchial asthma, a single nucleotide polymorphism (SNP) analysis of DNA obtained from the peripheral blood of patients with bronchial asthma and normal control will be performed.

Detailed description: Unrelated Kazaks subjects who have bronchial asthma were recruited in the current study. Genotyping for various SNP associated due to the linkage disequilibrium patterns is to be performed. Genotypes would be statistically compared between patients with bronchial asthma and normal control subjects free of bronchial asthma

Eligibility criteria: Inclusion Criteria:

* Persons with bronchial asthma confirmed by a doctor;
* The age of the patients is from 5 to 60 years;
* Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs.
* Persons who are able and willing to provide written informed consent;
* Persons capable and willing to comply with the research protocol;

Exclusion Criteria:

* Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
* Pregnant or lactating women;
* Tuberculosis of any localization in the active phase and in history;
* Severe and decompensated diseases of the liver and kidneys, cardiovascular system;
* Severe and decompensated course of endocrine diseases;
* Autoimmune diseases;
* Systemic diseases;
* Oncological diseases;

Primary outcomes:
measure: number of SNPs associated with bronchial asthma
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakhstan
Study officials:
References: