louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05422495: Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors
Official title: Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fall Patients
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Falls in the elderly are the cause of considerable morbidity and mortality and constitute a public health problem with more than 9000 deaths in France among the over 65s following an accidental fall. Many scientific data suggest that regular physical activity has significant and long-lasting beneficial effects on the health of the elderly and is associated with better functional status, a lower risk of falls and improved cognitive functions. However, the attraction to physical activity fades over the years and the reasons mentioned by the elderly for a low practice of physical activity are multiple, the main one being the worsening of their state of health.

The objective of this study is therefore to evaluate the impact of playful, motivating mobility training, stimulating both mobility and cognition, for 8 weeks, on the balance and mobility of elderly people in EHPAD, in particular in conditions of dual-task well known to be at high risk of falling, as well as on the prevention of falls.


Eligibility criteria: Inclusion Criteria:

* Subjects aged over 60, residing in nursing homes
* Subjects able to walk 15 meters unaided
* MMSE \> 10
* Visual acuity in both eyes \> 6/10
* Affiliated subject or beneficiary of a social security scheme
* Subject having given and signed an informed consent to participate in the study, or his/her guardian
* Subject having a sedentary activity or practicing a usual light to moderate physical activity (physical activities \< 6 METs)

Exclusion Criteria:

* Subject with a parkinsonian syndrome, any impairment of the motor neuron, pain limiting the practice of physical activity
* Subject with a modification of less than 3 months of psychotropic drugs
* Subject practicing high intensity physical activity (\> 6 METs)

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: change between baseline and 6 month
measure: MMSE globale cognitive assesment
timeFrame: change between baseline and 6 month
measure: Attention assessed by WAIS digit spans
timeFrame: change between baseline and 6 month
measure: Executive functions assessed by the TMT A AND B
timeFrame: change between baseline and 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT02336295: Developing and Validating a Food Frequency Questionnaires (FFQ) for the Vegan Population in Israel
Official title: Developing and Validating a Food Frequency Questionnaires (FFQ) for the Vegan Population in Israel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vegan Diet
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The study aims to validate a Food Frequency Questionnaire (FFQ) designed specifically for the vegan population in Israel. The participants will complete the FFQ, and the data will be verified by evaluating the participants energy expenditure (by measuring BMR, body composition and daily activity) and conducting a 24-hour food interview.


Eligibility criteria: Inclusion Criteria:

* consumption of beef, chicken, fish, eggs, milk or dairy is no more than once a month, for the last 6 months
* age 18-40

Exclusion Criteria:

* consumption of beef, chicken, fish, eggs, milk or dairy more than once a month
* chronic conditions (such as diabetes, hypertension, cardiovascular disease)

Primary outcomes:
measure: Daily energy consumption (Kcal/Day)
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Clinical Nutrition Unit, Sourasky Medical Center
Study officials:
References:
Clinical trial NCT02982395: Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
Official title: A Phase Ⅲ Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M (Docetaxel-PM) In Bacillius Calmette-Guerin Refractory Non-Muscle Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non Muscle Invasive Bladder Cancer
Keywords: Nanoxel M
Docetaxel PM
Docetaxel
Mitomycin C
BCG
BCG refractory
Non muscle invasive bladder cancer
intravesical
superficial bladder cancer
Urothelial carcinoma
Transitional cell carcinoma
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 36
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: The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of superficial transitional cell carcinoma of the bladder (Ta, T1)
* Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG)
* No previous intravesical therapy for 6 weeks
* No history of prior radiation to the pelvis
* Peripheral neuropathy ≤ grade 1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 t0 2
* Adequate hematopoietic and hepatic parameters

Exclusion Criteria:

* Muscle invasive disease (T2-T4)
* Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous cell skin cancers or noninvasive cancer of the cervix)
* Participation in any other research protocol involving administration of an investigational agent within 3 months before study entry
* History of sensitivity reaction to docetaxel
* Prescribed immunosuppressive medications because of a confounding medical condition
* Female patients who were pregnant or lactating

Primary outcomes:
measure: Recurrence free rate
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence free rate
timeFrame: 6 months, 2 years
measure: Overall survival
timeFrame: 2 years
measure: Number of participants with adverse events as assessed by CTCAE v4.0
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ja Hyeon Ku
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05449795: Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults
Official title: Evaluation of the Performance of Contour Next® and Contour Plus Elite® Blood Glucose Monitoring Systems (BGMS) in Arterial Blood Samples From Hospitalized Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - The subject population will consist of adults who are hospitalized in a Critical Care Unit, (medical and surgical intensive care units (ICUs)) at the Investigational site.

Brief summary: The purpose of the study is to extend the intended use of two BGMSs to include testing of arterial blood by Health Care Professionals (HCP) in a clinical setting.

Detailed description: This trial will evaluate the performance of both Contour Next BGMS and Contour Plus Elite BGMS using arterial blood from adult patients hospitalized in a Critical Care Unit (medical and surgical intensive care units (ICUs)). The investigational BGMS will be tested by a Point-of-Care (POC) operator in a clinical setting using residual arterial blood samples from adults who underwent prescribed arterial blood tests that were deemed necessary due to their medical conditions.

Eligibility criteria: Inclusion Criteria:

* Patients who are at least 18 years old.
* Residual Arterial blood samples collected from subjects hospitalized in a Critical Care Unit (medical and surgical intensive care units (ICUs)).
* Sample blood volume must be sufficient to complete investigational testing procedures clinical laboratory testing.

Exclusion Criteria:

- Residual arterial blood samples collected from subjects previously enrolled. and evaluated for this study.

Primary outcomes:
measure: Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values
timeFrame: 1 day
measure: Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital , ICU Research Unit
state: South Australia
Study officials:
References:
Clinical trial NCT02740595: E-cigarettes and Blood Vessel Function
Official title: The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: nicotine
endothelial function
oxidative stress
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 148
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on endothelial function and markers of oxidative stress.

Detailed description: Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and undergo a measure of endothelial function called brachial artery flow mediated dilatation (FMD). Additionally, oxidative stress will be measured pre and post exposure.

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Cardiac disease
* Respiratory disease
* Diabetes mellitus

Primary outcomes:
measure: Flow mediated dilatation (FMD)
timeFrame: 10 minutes after exposure
measure: Paraoxonse
timeFrame: less than 1 hour after exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCaliforniaLA
state: California
Study officials:
References:
Clinical trial NCT00032695: Treatment of AIDS Vacuolar Myelopathy With Methionine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myelopathy
AIDS-Myelopathy
AIDS Vacuolar Myelopathy
Keywords: myelopathy
AIDS-myelopathy
AIDS vacuolar myelopathy
methionine
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Sponsor class: NIH
First posted: 2002-03-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether methionine, an amino acid present in low doses in the normal diet, can improve myelopathy or stop its progression.

Detailed description: Myelopathy is usually a late complication of AIDS, and until recently its symptoms were rarely recognized, masked by the general state of disability or the presence of other neurological complications. With prolonged survival and improved quality of life of HIV-infected patients, myelopathy is increasingly becoming a common source of disability. The cause of AIDS-myelopathy is unknown, but it is probably an indirect effect of the long-term presence of the HIV virus in the nervous system rather than the result of a direct infection. The purpose of this study is to determine whether methionine, an amino acid present in low doses in the normal diet, can improve myelopathy or stop its progression.

Eligibility criteria: Between 18 and 80 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
name: Alessandro Di Rocco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05534295: Strokecopilot: A Precision Medicine Tool in the Stroke Emergency
Official title: Strokecopilot: A Precision Medicine Tool in the Stroke Emergency
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrovascular Accident (CVA)
Keywords: cerebrovascular accident (CVA)
Ischemic stroke
thrombolysis channels
intravenous thrombolysis
mechanical thrombectomy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (\>18 years old) admitted to the thrombolysis unit of the University Hospital of Strasbourg

Brief summary: Ischemic stroke or cerebral infarction (CI) is an immediate emergency affecting approximately 100,000 - 150,000 patients each year in France and is managed in the neurovascular intensive care unit (NICU). Recanalization treatments can prevent disability, but patients must be carefully selected. Knowledge in this field is evolving rapidly, which tends to make management more complex and personalized. In addition, the permanence of thrombolysis channels involves neurologists of all expertise. Decision support tools are desirable to enable precision medicine in stroke. Strokecopilot is a web application developed by the principal investigator. Its algorithm contextualizes the patient in a set of evidence-based medicine references (recommendations and clinical trials) and gives the result of their cross-referencing to the user to indicate theoretical indications for intravenous thrombolysis and mechanical thrombectomy.


Eligibility criteria: Inclusion criteria:

- Adult patient (\>18 years old) admitted to the thrombolysis unit of the University Hospital of Strasbourg from January 01, 2017 to December 31, 2021

Exclusion criteria:

- Subjects who have expressed their opposition to the use of their data for scientific research purposes.

Primary outcomes:
measure: Retrospective analysis of thrombolysis data for the development of an algorithm to detect thrombolysis
timeFrame: Files analysed retrospectively from January 01, 2017 to December 31, 2021 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service : Unité Neurovasculaire - CHU de Strasbourg - France
Study officials:
affiliation: Service : Unité Neurovasculaire - CHU de Strasbourg - France
name: Valérie WOLFF, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service : Unité Neurovasculaire - CHU de Strasbourg - France
name: Stanislas DEMUTH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03512795: Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations
Official title: Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients living with HIV-1, with an undetectable viral load and a history of at least 2 virological failures in which resistance to at least two drug classes was observed

Brief summary: The analysis of HIV resistance to antiretrovirals (Sanger sequencing on RNA) is difficult when the viral load is undetectable or during therapeutic breaks. In these situations, the ultra-deep sequencing (UDS) can be done on proviral DNA in order to improve characterization of archived resistant variants with may reflect past virological failures.

This study is a cross-sectional study which will require only one additional tube which can be taken during a routine check-up as part of the usual follow-up of the individuals included.


Eligibility criteria: Inclusion Criteria:

* Patient who has given consent
* Adult patient
* Patient living with HIV-1
* Controlled viral load (\<50 RNA copies/ml) for at least 1 year.
* At least two previous virologic failures, either :

  * Initial failure : defined as the persistence of a viral load greater than 50 copies/ml beyond 1 year, after the initiation of triple antiretroviral therapy, and without virological control (VL \> 50 copies/ml) since the initiation of the very first antiretroviral treatment.
  * A rebound in HIV viral load to more than 50 copies/ml after a period of virological success, confirmed on two consecutive samples at least one month apart.
* At least 2 Sanger RNA genotypes have been done or could be done from the existing library.

Exclusion Criteria:

* Patient not affiliated to a medical insurance scheme
* Protected adult
* Pregnant, parturient or breastfeeding woman
* Discontinuation of clinical and immuno-virological follow-up for more than 2 years

Primary outcomes:
measure: > Genotyping Score (GSS) comparison between HIV DNA-UDS genotyping assay obtained at inclusion and cumulative RNA-Sanger genotyping assays obtained at each virological failure during routine follow
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT04638595: Pediatric Normative Movement Analysis Data Collection
Official title: Pediatric Normative Movement Analysis Data Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ALL
Lead sponsor: MultiCare Health System Research Institute
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A group of 50 neurotypical pediatric subjects will be recruited for this data collection. Children will be assigned to 1 of 5 age groupings (3-5, 6-8, 9-11, 12-14, 15-18), with an equal amount of male/female in each.

Brief summary: The objective of this project is to collect baseline data from a normative population of children that gender and age matches the population of patients expected to be treated by Mary Bridge Children's Therapy Services and seen in the Research and Movement Laboratory. This project seeks to recruit 25 male and 25 female typically developing children between the ages of 3 and 18 years of age. Non-invasive measurements of movement patterns will be collected during common activities of daily living over a single data collection session.


Eligibility criteria: Inclusion Criteria:

* Age between 3-18 years
* Ambulate independently and without the use of assistive devices
* Perform activities of daily living without physical assistance
* Tolerate adhesive markers placed on skin and clothing
* Willing and interested in participating

Exclusion Criteria:

* Neuromuscular disorders such as cerebral palsy, muscular dystrophy, myotonic dystrophy, spinal muscular atrophy, peripheral neuropathy, or other generalized muscle and/or nerve issues
* Evidence of developmental delays, muscle weakness, decreased muscle tone, joint stiffness, muscle or bone deformity
* Currently using or has a history of using assistive technology devices, bracing/orthoses, manual or powered mobility equipment
* Was born pre-term
* Currently or has a history of taking medication or pharmaceutical treatment related to musculoskeletal side-effects/scenario/diagnosis

Primary outcomes:
measure: Create normative baseline data for typically developing children
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Puyallup
country: United States
facility: Mary Bridge Children's Therapy Unit
state: Washington
Study officials:
References:
Clinical trial NCT04725695: Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy
Official title: Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy - a Blinded, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthetics, Local
Esophagogastroduodenoscopy
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy


Eligibility criteria: Inclusion Criteria:

* Patients referred to and found fit for upper GI endoscopy in an out patient setting
* Between 18 and 75 years old
* Speaks and understands Danish

Exclusion Criteria:

* Patients admitted for upper GI endoscopy in an in-patient setting
* Patients with dementia and/or other cognitive dysfunction disorders
* Patients primarily complaining of dysphagia
* Patients allergic to lidocaine
* Patients with suspected retention
* Patients who will undergo upper GI endoscopy with nurse-assisted propofol sedation
* Patients who will undergo upper GI endoscopy with assistance of anesthesia-personnel

Primary outcomes:
measure: Ease of intubation
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Ease of examination
timeFrame: Immediately after the procedure
measure: Number of intubation attempts
timeFrame: Peroperatively counted by the assisting nurse
measure: Number of gag reflexes
timeFrame: Peroperatively counted by the assisting nurse
measure: Patient's perception of discomfort
timeFrame: Immediately after the procedure
measure: Patient's willingness to be reexamined
timeFrame: Immediately after the procedure
measure: Sedation 1
timeFrame: Peroperatively
measure: Sedation 2
timeFrame: Peroperatively
measure: Perception of gag reflexes
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Endoscopy, Digestive Disease Center, Bispebjerg Hospital
Study officials:
affiliation: Digestive Disease Center, Bispebjerg Hospital
name: Erling Oma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: