louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01595906: The Affect of a Ventilated Helmet on Physiological Load
Official title: The Affect of a Ventilated Helmet System on Human Physiological Load
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physiological Strain
Keywords: Helmet
Heat Tolerance Test
ventilation System
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 12
Sex: MALE
Minimum age (years): 21
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The use of infantry helmets under heavy heat stress conditions, during physical exertion, may hinder the body's ability to effectively dissipate heat from the head area, thereby damaging the soldier's function. Therefore head cooling may potentially enable a longer duration of activity until reaching fatigue. An improvement in function may also be possible.The purpose of this research is to determine the extent of the cognitive and physiological strain caused by wearing a helmet under exertional conditions while exposed to heavy heat stress and to evaluate the effect of a unique ventilation system connected to the helmet on strain reduction.

Detailed description: 12 young, healthy civilian volunteers, aged 21-28 will participate in the study. Following a day of examinations and 6 days of acclimatization in a climatic chamber in accordance with a well accepted protocol, the subjects will undergo 3 days of experiment that will include exposure to hot environmental conditions with different helmet-wearing scenarios, while wearing uniform and a combat vest: (a) without a helmet (b) with a helmet (c) with a helmet connected to a ventilation system. All 3 scenarios will include a two hour effort (walking on a treadmill) in heavy heat stress in the climatic chamber at our institute (the Heller institute of medical research).

Eligibility criteria: Inclusion Criteria:

* healthy civilian volunteers
* aged 21-28
* without known medical illnesses or medication use

Exclusion Criteria:

* the existence of or suspicion of existing cardiac or respiratory disease
* hypertension
* diabetes
* any hormonal disease or any other chronic illness that may inhibit participation in the experiment
* infectious disease 3 days prior to the experiment.

Primary outcomes:
measure: Physiological strain
timeFrame: 9 days
Secondary outcomes:
measure: Rectal temperature
timeFrame: 9 days
measure: Skin temperature
timeFrame: 9 days
measure: Heart Rate
timeFrame: 9 days
measure: Sweat Rate
timeFrame: 9 days
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Heller insitute, Sheba hospital
Study officials:
affiliation: IDF medical corps
name: Amit Druyan, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02203006: HIV Patients Cohort
Official title: Constitution of an Open Monocentric Cohort of HIV Infected Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patients Affected by the HIV
Keywords: HIV,
infection,
cohort
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 1613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to improve our knowledge concerning HIV infection, treated or not, in the current conditions of care to optimize it.

Detailed description: Since the arrival of highly active tritherapies, HIV infection became mainly an ambulatory chronic pathology centred on a long term care taking into account the complication of long-term treatment as well as the arisen of new problem bound to a prolonged survival and ageing. So the care is more and more in a prevention and screening approach with in particular the care of metabolic and cardiovascular complication due to antiretroviral treatment.

As a reorganization of the coverage of the HIV infected people take place on the Hotel Dieu Hospital it thus seems important to double this care optimization with a clinical research side. This will be done in constituting an HIV patient cohort including a blood sample collection to contribute to the vigilance of the complication to due the infection.

Our ultimate objective is to optimize the selection of the treatment. It is important to do it to be able to have, on many years duration, precise clinical information and biological sample allowing to realize later some assay and analyse the influence of some genetic markers.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years old,
* Patients with an HIV infection
* patients having given their written informed consent.

Primary outcomes:
measure: HIV infection
timeFrame: 10 years
Secondary outcomes:
measure: Comorbidity and complication in HIV infected patients
timeFrame: 10 years
measure: efficiency of the current antiretroviral therapeutic diets
timeFrame: 10 years
measure: Blood sample collection
timeFrame: 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Hôtel Dieu
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Marc Tréluyer, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05469906: Evaluation at 5 and 10 Years of Renal Transplant Patients
Official title: Evaluation at 5 and 10 Years of Renal Transplant Patients Who Received a Graft Preserved in a Solution HEMO2life®
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transplant; Complication, Failure
Keywords: renal transplantation
organ preservation
oxygen carrier
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 116 patients previously included in the oxyop study

Brief summary: 5 and 10 years follow-up of the oxyop study.

Detailed description: Oxyop (NCT02652520 PHRC) was a safety study evaluating the use of an oxygen carrier HEMO2life® as an additive in organ preservation solution in 60 transplanted kidneys. This was a national multicenter (6 centers) open-labeled safety study on HEMO2life® that included 58 recipients. The first patient was included on March 24th, 2016 and the study was completed on February 23th, 2018 (1 year of recruitment and 1 year of follow-up). Some efficacy secondary end points using a paired analysis was also analyzed (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop 5 and 10 years aims to analyse 5 and 10 years results.

Eligibility criteria: Inclusion Criteria:

* informed patients participating to the oxyop study
* Patient having completed the OXYOP M12 follow-up visit
* Patient agreeing to participate in the observational study

Exclusion Criteria:

* Opposition to the use his medical data
* patient deceased or with graft lost before M48

Primary outcomes:
measure: eGFR
timeFrame: 10 years
Secondary outcomes:
measure: patient survival
timeFrame: 5 and 10 years
measure: graft survival
timeFrame: 5 and 10 years
measure: rejection rate
timeFrame: 5 and 10 years
measure: infection rate
timeFrame: 5 and 10 years
measure: hospitalization
timeFrame: 5 and 10 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
affiliation: University hospital Brest France
name: Yannick Le Meur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05482906: Common and Specific Information From Neuroimaging and Smartphone
Official title: Individual Gait Pattern and MRI Lesion Load to Quantify Gait Impairment in MS: A Cross Sectional Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Wearable sensor
Gait
MRI
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Rennes University Hospital
First posted: 2022-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MS patients cohort followed at Nantes university hospital or Rennes university hospital (OFSEP HD cohort)

Brief summary: Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. Umanit and LMJL (Nantes university) has developed a device call egait to assess walking ability in individuals (eg MS patients).

Detailed description: This device consists in a commercialized IMU sensor (MetaMotionR Sensor, Mbientilab) worn at the right hip, a smartphone app and dedicated algorithm/mathematical model to extract raw sensor data and calculate individual gait pattern (IGP). This IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle. Pursue previous works conducted on (IGP to assess) gait alteration in MS by adding (to IGP) new information from MRI.

Eligibility criteria: Inclusion Criteria :

* Diagnosis of MS based on McDonald criteria (including Relapsing-remitting and progressive MS)
* Over 18 years old /age greater than 18 years
* Patients followed at Nantes university hospital or Rennes university hospital
* Last known EDSS before inclusion ranging from 0 to 6 inclusive/EDSS of 0 to 6 inclusive, prior inclusion
* No relapse within 3 months
* With a Medullar MRI planed as part as usual care
* Affiliated person or beneficiary of a social security scheme

Exclusion Criteria :

* Bilateral aid needed to walk
* Women who are pregnant
* Patient having expressed their opposition
* Patient under guardianship or security measure

Primary outcomes:
measure: Clustering analyze based on IGP
timeFrame: At the inclusion
measure: Clustering analyze based on EDSS score
timeFrame: At the inclusion
measure: Clustering analyze based on MRI lesion load
timeFrame: At the inclusion
Secondary outcomes:
measure: Correlation with disability
timeFrame: At the inclusion
measure: Correlation with MRI lesion load
timeFrame: At the inclusion
measure: Building a predictive model for lesion load involving in walk ability from IGP
timeFrame: At the inclusion
measure: Building a predictive model for group belonging from group established in main outcome based on IGP
timeFrame: At the inclusion
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References:
Clinical trial NCT04203706: Behavioral and Neurofunctional Correlates of Intentional Motor Behaviors Towards Edible Stimuli in Normal-weight Subjects
Official title: Behavioral and Neurofunctional Correlates of Intentional Motor Behaviors Towards Edible Stimuli in Normal-weight Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Oriented Behavior
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate, through behavioural tests combined with advanced neurofunctional methods, the neural bases of intentional behaviours towards edible stimuli using explicit and implicit paradigms in normal-weight subjects.

This knowledge will then be expanded with the study of associations between behavioral/neurofunctional measures and blood/hummon parameters.


Eligibility criteria: Inclusion Criteria:

* Normal weight (Body mass index - BMI - comprised between 18.6 and 24.99.
* Absence of usual contraindications to MRI examination (e.g. pacemakers, fixed hearing implants, presence of metallic foreign bodies, intrauterine bodies, metallic splinters or fragments, metallic prostheses, screws, nails, fixed or mobile dental prostheses).
* Signature of informed consent and consent to cooperate in all study procedures.

Exclusion Criteria:

* Previous diagnosis of significant neurological disorders (brain damage or dementia), major psychiatric disorders or eating disorders (binge-eating disorder, bulimia).
* BMI less than 18.5 and greater than or equal to 25 Kg/cm2.
* Serious medical conditions, including but not limited to: hypertension, significant heart disease, disorders or illnesses that may compromise patient safety.
* Pregnancy and Claustrophobia.

Primary outcomes:
measure: BOLD Response
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00420706: Study Evaluating SCA-136 Tolerability With Dose Titration and Food
Official title: A Multi-Dose, Double-Blind, Parallel-Group Study of the Effects of Dose Titration and Administration With Food on the Tolerability of SCA-136 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate whether the tolerability of SCA-136 is improved by dosing with food or by increasing dose amounts in a step-wise fashion.


Eligibility criteria: Inclusion Criteria:

* Healthy men or women, aged 18 to 50 years

Exclusion Criteria:

* Abnormal vital signs, ECG, or lab results

Primary outcomes:
measure: The primary endpoint is the proportion of subjects reporting nausea (based on AEs) over the dosing period.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06113406: Evaluation of Virtual Reality in Hazmat Training
Official title: Evaluation of Virtual Reality in Hazmat Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Disease or Condition is Being Studied
Evaluating a Brief Intervention
Does Virtual Reality Aid in Hazmat Training
Lead sponsor: MetaMedia Training International, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An experimental and a pretest-posttest control group design method were applied in this regard.
Primary purpose: OTHER

Brief summary: Type of study: Two-group comparison.

Main question it aims to answer:

Does the use of virtual reality emergency scenarios provide a practical and effective tool to supplement traditional instructor-led training for first responder trainees?

A. For the traditional hazmat response training group; Traditional training will be held in the classroom environment for 45 minutes in the form of a lecture, then the training session will be terminated.

B. For VR hazmat response training group; After the traditional classroom session has ended, the participants will complete the additional VR training scenario, online content, and question-answer session. Once completed the session will be closed.


Eligibility criteria: Inclusion Criteria:

* currently enrolled in a hazmat training course

Exclusion Criteria:

* under the age of 18 or over the age of 65

Primary outcomes:
measure: Keywords identified on questionnaire
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Frederick
country: United States
facility: MetaMedia Training International
state: Maryland
Study officials:
References:
Clinical trial NCT01818206: Bacteriophage Effects on Pseudomonas Aeruginosa
Official title: Bacteriophages Effects on Pseudomonas Aeruginosa Presents in Sputum of Cystic Fibrosis (CF) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Bacteriophages
Pseudomonas aeruginosa
Sputum
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 59
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been investigated in animals. The aim of the present study is to evaluate the efficacy of bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages strains in sputum samples collected. Then the sensitivity of individual colony will be tested.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Affiliated or benefit from a disease insurance regimen
* Men and women
* Aged from at least 6 years old
* Confirmed Diagnosis of cystic fibrosis based on presence of 2 mutations of CFTR gene and/or 2 positive tests of sweat chloride and/or 2 measures of pathologic difference of nasal potential associated to cystic fibrosis clinical signs.
* Patients able to produce sputum
* Pseudomonas aeruginosa Chronic infected patients

Exclusion Criteria:

* Simultaneous participation to another project on anti-infection, anti-inflammatory or modificating agents
* Subjet in exclusion period
* Law protected patient
* Realisation of sputum production is contra-indicated

Primary outcomes:
measure: Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage
timeFrame: after 6 hours in presence of bacteriophage
Secondary outcomes:
measure: Pseudomonas aeruginosa (PA) strains counts after 24 hours in presence of bacteriophage
timeFrame: after 24 hours in presence of bacteriophage
measure: Bacteriophage counts after 6 hours incubation within sputum samples
timeFrame: after 6 hours incubation within sputum samples
measure: Sensitivity of individual Pseudomonas aeruginosa (PA) colonies to bacteriophages
timeFrame: Sensitivity of individual PA colonies to bacteriophages
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM
state: Languedoc Roussillon
Study officials:
affiliation: CHU de Montpellier - Hôpital Arnaud de Villeneuve
name: Raphaël RC CHIRON, RC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06334406: Antitumor T Cell Responses in Patients With Bladder Cancer
Official title: Study of Antitumor T Cell Immune Responses in Patients With Bladder Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bladder Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 33
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 treated for a bladder cancer

Brief summary: The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing transurethral resection of the bladder (TURBT) for a tumor detected by cystoscopy with a histological diagnosis of a non-infiltrating or muscle-infiltrating tumor
* For muscle-invasive tumors: localized tumors (T2-T3N0M0) or locally advanced (T4N0M0)
* Written informed consent

Exclusion Criteria:

* History of TURBT for a bladder tumor whatever the stage
* Stages N1-3 or M1 on initial assessment
* Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
* History of cancer in the last 3 years other than basal cell carcinoma or non-invasive cervical cancer
* HIV, hepatitis C or B infection
* Patients with any medical or psychiatric condition or disease,
* Patients under guardianship, curatorship or under the protection of justice.

Primary outcomes:
measure: Tumor antigen specific T-cell responses
timeFrame: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Secondary outcomes:
measure: Monitoring of T cells in the blood
timeFrame: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
measure: Monitoring of immune cell death parameters in the blood
timeFrame: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
measure: Monitoring of immune suppressive cells in the blood
timeFrame: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
measure: Overall survival
timeFrame: Date of death from any cause (within 2 years after the initiation of the treatment)
measure: Progression-free survival
timeFrame: date of first progression of the disease (within 2 year after the initiation of the treatment)
measure: Local progression-free survival
timeFrame: date of first local progression of the disease (within 2 year after the initiation of the treatment)
measure: Transcriptomic analysis
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00204906: Correction of Vitamin D Inadequacy in Nursing Home Residents
Official title: Effect of Vitamin D Supplementation on Skeletal and Overall Health of Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypovitaminosis D
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy.

Detailed description: Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy. Subjects with low vitamin D concentrations are dosed with 50.000 IU three times a week for 25 hydroxy vitamin D, parathyroid hormone and bone turnover status. .

Eligibility criteria: Inclusion Criteria:

* Able to walk
* Reside in nursing home for the 12 weeks of study

Exclusion Criteria:

* Non-ambulatory residents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Neil C Binkley, MD
role: PRINCIPAL_INVESTIGATOR
References: