louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01834417: Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients ( PRESDIE)
Official title: Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Pressure ulcer, spinal cord injury, on-board device
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 90
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: Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. A control is done every week and the device can be changed until it is returned at the end of the study period.

Detailed description: * inclusion visit : recovery of the signed informed-consent form, clinical examination, skin control, seat-pressures control, device 9-position control, delivery of the agenda for noteworthy events
* 3 follow-up visits : noteworthy events check, skin control, cushioncloth control, device 9-position control
* return visit : device return, agenda return, skin control, seat-pressures control

Eligibility criteria: Inclusion criteria :

* Patient is male or female, aged ≥ 18
* Patient accepting the initial assessment and the following visits during the protocol
* Written informed consent has been obtained
* Patient having a social assurance
* Spinal cord injury ≤ C6 stable Spinal cord trauma \> 1 an
* Main mode of ambulation : own manual wheelchair

Exclusion criteria :

* Aged ≤ 18
* Adults under guardianship
* Patients do not speak French, refusing or unable to be followed
* Pregnant or lactating women
* Person deprived of their liberty by judicial or administrative decision
* Person hospitalised without consent
* Pelvic pressure ulcer ongoing
* Cognitive disorder incompatible with the use of the device, understanding and conduct of the study

Primary outcomes:
measure: Intra- and inter-patients variability of stored pressures for the whole included population Intra- and inter-patients variability of stored pressures for the whole included population
timeFrame: 4 weeks
Secondary outcomes:
measure: Intra- and inter-patients variability of stored pressures for subpopulations
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: CHU de Nantes- Hôpital Saint Jacques
name: Brigitte PERROUIN-VERBE, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Nantes-Hôpital Saint Jacques
name: Marc Le Fort, PH
role: STUDY_CHAIR
affiliation: Centre de l'Arche
name: Guy Egon
role: STUDY_CHAIR
affiliation: CH Raymond Poincaré
name: Djamel Bensmail, PU-PH
role: STUDY_CHAIR
References:
Clinical trial NCT03832517: Single and Multiple Dose Escalation Trial of an Intravenous Antibiotic RC-01
Official title: A Phase 1, Double-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RC-01 for Injection in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Safety
Lead sponsor: Recida Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-06
Enrollment: 8
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: A Phase 1 study of the safety, tolerability and pharmacokinetics of a new antibiotic (RC-01). In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of RC-01. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of RC-01 given either twice daily or three times daily.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments
* Willing and able to provide written informed consent

Exclusion Criteria:

* Underlying hepatic, renal, metabolic, cardiovascular or immunologic disorders
* Unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements
* Women who are pregnant and/or nursing

Primary outcomes:
measure: Number of participants with a treatment-related adverse event collected over the duration of the study
timeFrame: Up to the final follow-up 1 day visit
Secondary outcomes:
measure: Plasma concentration time data for RC-01 and metabolites
timeFrame: Pre-dose through 24 hours after the final infusion of study drug
measure: Bioavailability of RC-01 and other RC-01 metabolites
timeFrame: Pre-dose through 24 hours after the final infusion of study drug
measure: Elimination of RC-01 and its metabolites in the urine following single and multiple dose administration
timeFrame: Pre-dose through 24 hours after the final infusion of study drug
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Celerion
state: Arizona
Study officials:
References:
Clinical trial NCT03689517: Placebo Modulation of Orthodontic Pain
Official title: Placebo Modulation of Orthodontic Pain: a Single-blind Functional MRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 23
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: How placebo modulates orthodontic pain remains largely unknown. The present study aimed to investigate the placebo modulation of brain activity associated with orthodontic pain using fMRI.

Detailed description: How placebo modulates orthodontic pain remains largely unknown. The present study aimed to investigate the placebo modulation of brain activity associated with orthodontic pain using fMRI. 23 voluneers were recruited in a longitudinal fMRI experiment. At both the baseline and the one-month follow-up, orthodontic separators were placed between right lower molars 24 hours before MRI scans. At baseline, the subjects were scanned without placebo while all subjects took placebos half an hour before the scan at follow-up. Scans include a bite/non-bite task fMRI and a followed resting state fMRI. A generalized linear model was used to identify pain-regulating network from task fMRI, and functional connectivity analysis of pain related brain regions was performed to study the possible modulation of placebo on connectivity of pain-regulating networks using resting-state fMRI.

Eligibility criteria: Inclusion Criteria:

* Female, 20-25 years old;
* Right handed;
* Understand the Visual Analog Scale;
* No history of serious illness, surgery, psychiatric disorders or neurological;
* No history of drug or alcohol abuse;
* No Maxillofacial diseases, agomphiasis, caries, metal filling material or crown;
* Individual normal occlusion with no orthodontic treatment history.

Exclusion Criteria:

* claustrophobic or experienced obvious adverse reactions including fear, nausea, vomiting
* discomfort during the scan process or during menstruation.

Primary outcomes:
measure: fMRI data change during MRI scan
timeFrame: Day 1
Secondary outcomes:
measure: The chronological changes of anxiety level
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: West China hospital of stomatology
name: Wenli Lai, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03078517: Comparison of the LMA Protector and the I-gel
Official title: Comparison of the LMA Protector and the I-gel in Anesthetized Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Keywords: I-gel
Laryngeal mask airway protector
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators aim to compare two supraglottic airway devices; the i-gel and the newly developed laryngeal mask airway protector in terms of airway sealing effect, the insertion success rate, and the incidence of complications in anesthetized patients.


Eligibility criteria: Inclusion Criteria:

* Requirement for mechanical ventilation under general anesthesia

Exclusion Criteria:

* Surgical position other than supine position
* Tumors or anatomical abnormalities in the upper airway
* Known or predicted difficult airway
* Body mass index \> 30 kg/m2
* Required postoperative mechanical ventilation
* Head and neck surgery
* Aspiration tendency

Primary outcomes:
measure: Oropharyngeal airway leak pressure
timeFrame: At 5 min after the insertion of i-gel or LMA protector
Secondary outcomes:
measure: Number of insertion attempt for the successful placement
timeFrame: During the insertion of i-gel or LMA protector
measure: Insertion time
timeFrame: During the insertion of i-gel or LMA protector
measure: Ease of insertion
timeFrame: During the insertion of i-gel or LMA protector
measure: Ease of gastric tube insertion
timeFrame: At 25 min after the insertion of i-gel or LMA protector
measure: The accuracy of insertion location of the device in the oropharyngeal space
timeFrame: At 15 min after the insertion of i-gel or LMA protector
measure: Blood staining on the i-gel or LMA protector
timeFrame: Immediately after removal of i-gel or LMA protector
measure: The incidence and severity of postoperative sore throat
timeFrame: At 1 and 24 h after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jin-Young Hwang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang JE, Kim H, Lee JM, Min SW, Won D, Jun K, Hwang JY. A prospective, randomized comparison of the LMA-protector and i-gel in paralyzed, anesthetized patients. BMC Anesthesiol. 2019 Jul 4;19(1):118. doi: 10.1186/s12871-019-0785-8.
Clinical trial NCT00743717: Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement
Official title: Clinical Trial on the Zirconia Femoral Component for the Gem Total Knee System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: total knee arthroplasty
osteoarthritis
ceramic bearing
zirconia
Lead sponsor: Kinamed Incorporated
Sponsor class: INDUSTRY
First posted: 2008-08-29
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery. The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.

Detailed description: Due to excellent biocompatibility and wear characteristics, ceramics have a long history of success in total hip arthroplasty (THA). Use of a ceramic-polyethylene wear couple in total knee arthroplasty (TKA) has shown promising laboratory and early clinical results. The use of ceramics in this study is intended to address long-term failure of TKA due to osteolysis associated with polyethylene wear debris.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature
* Primary TKA for osteoarthritis or post-traumatic arthritis of the knee joint
* Stable or reconstructable collateral and posterior cruciate ligaments
* Correctable deformity
* Intact quadriceps and hamstrings mechanisms
* Patella bone thick enough (at least 15 mm) after resection

Exclusion Criteria:

* Previous TKA
* Bilateral knee arthritis
* Non-availability for follow-up
* Mental incompetence or confinement
* Patients being treated with other investigational devices for same disorder
* Infection
* Osteoporosis, acute renal failure, or other disorders known to affect bone quality
* Charcot's or Paget's disease
* Patient physical condition preventing use of appropriate size implant
* Disease conditions affecting blood supply to knee
* Insufficient bone quality or quantity
* Physical condition predisposing implant to extreme loads
* History of septic knee arthritis
* History of drug abuse

Primary outcomes:
measure: Knee Score at 2 Years Post Operation
timeFrame: within 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kinamed Incorporated
name: Vineet Sarin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02431117: Non-drug Study to Assess the Suitability of Assessment Scales in Japanese Individuals With Down Syndrome Aged 6-30
Official title: A Multicenter, Longitudinal, Non-drug Study to Assess the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Japanese Individuals With Down Syndrome Aged 6-30
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-04-30
Enrollment: 43
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with Down syndrome

Brief summary: To evaluate the suitability (i.e. number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values) of neurocognitive tests and functioning scales in view of their use in future multicenter, multinational clinical efficacy trials testing a putative cognitive enhancer for individuals with Down syndrome aged 6-30.


Eligibility criteria: Inclusion Criteria:

* Subjects may have standard trisomy 21, Robertsonian translocation, isochromosome21,Down syndrome with reciprocal translocation or mosaicism.
* Availability of parent or other reliable caregiver who agrees to accompany the subject to clinic visits, provide information about the subject's behavior and symptoms.
* Down Syndrome subjects meeting clinical diagnostic criteria for generalized anxiety disorders, major depressive disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can participate to the study provided they are on stable medication for at least 8 weeks prior to screening.

Exclusion Criteria:

Individuals who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment or other issues judged relevant by the investigators.

Primary outcomes:
measure: Suitability for individuals with Down syndrome assessed by number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values.
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sapporo
country: Japan
state: Hokkaido
city: Yokohama
country: Japan
state: Kanagawa
city: Izumi
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Saitama
country: Japan
Study officials:
affiliation: Chugai Pharmaceutical
name: Hideaki Takahashi
role: STUDY_DIRECTOR
References:
Clinical trial NCT01895517: CervIcal Cancer Screening Trial by Randomization of HPV Testing Intervention for Upcoming Screening （CITRUS Study）
Official title: Randomized Controlled Trial to Evaluate the Efficacy of Concurrent Liquid-based Cytology ( LBC) and HPV DNA Testing Versus LBC Alone for the Primary Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Cancer
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Keio University
name: Jikei University School of Medicine
First posted: 2013-07-10
Enrollment: 18471
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study is to assess efficacy of the screening with concurrent liquid-based cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.


Eligibility criteria: Inclusion Criteria:

1. Women aged 30-64 years old
2. Participants provided written informed consent

Exclusion Criteria:

Women who

1. will receive planed HPV DNA testing by local governmental cervical cancer program next six years
2. have had cervical invasive cancer before
3. have undergone cervical conization
4. have undergone hysterectomy
5. have had or have the cytological abnormalities and are under follow-up
6. are pregnant
7. are judged ineligible for this trial by physician

Primary outcomes:
measure: The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period
timeFrame: 6 years
Secondary outcomes:
measure: The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline
timeFrame: 2 years, 4 years, 6 years
measure: The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline
timeFrame: 2 years, 4 years, 6 years
measure: The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline
timeFrame: 2 years, 4 years, 6 years
measure: The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline
timeFrame: 2 years, 4 years, 6 years
measure: The number of cervical cytology performance
timeFrame: 6 years
measure: The number of colposcopy and biopsy performance
timeFrame: 6 years
Other outcomes:
Locations:
city: Shinjuku
country: Japan
facility: School of Medicine, Keio University
state: Tokyo
Study officials:
References:
citation: Morisada T, Teramoto K, Takano H, Sakamoto I, Nishio H, Iwata T, Hashi A, Katoh R, Okamoto A, Sasaki H, Nakatani E, Teramukai S, Aoki D. CITRUS, cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening: Design, methods and baseline data of 18,471 women. Cancer Epidemiol. 2017 Oct;50(Pt A):60-67. doi: 10.1016/j.canep.2017.07.017. Epub 2017 Aug 16.
Clinical trial NCT04028817: Sublingual Photobiomodulation in Parkinson's Disease
Official title: Evaluation of the Concentrations of Inflammatory, Protein and Oxidative Biomarkers of Parkinson's Disease After Photobiomodulation From Sublingual Laser Application - Clinical, Randomized and Blind Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: parkinson's disease
Photobiomodulation
Inflammation
Oxidative stress
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 40
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: This study evaluates the use of photobiomodulation in the treatment of patients with Parkinson's disease. Half of participants will receive treatment with low level laser therapy and exercises in combination, while the other half will receive a placebo laser combined with exercises.


Eligibility criteria: Inclusion Criteria:

* patients with Parkinson's disease diagnosed with the criteria of the UK Parkinsons' Disease Society Brain Bank Clinical Diagnostic Criteria
* In the stages I to III of the disease according to Hoehn \& Yahr's Parkinson's disease staging scale - modified;
* Individuals of both sexes,
* with more than 50 years
* who sign the informed consent form

Exclusion Criteria:

* patients who present some adverse event during the development of the study,
* Who have another associated neurodegenerative disease,
* Have blood dyscrasia, HIV, heart failure, hepatic or renal insufficiency, infections, neoplasias, respiratory disorders, hypophysis and hypothalamus problems.
* Who fail to understand or perform procedures correctly because of physical and mental limitations.

Primary outcomes:
measure: 10-meter walk test
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Daysi da Cruz Tobelem
Study officials:
References:
Clinical trial NCT04992117: Unplanned-extubation in the ICU; Incidence, Characteristics and Prognosis. Success And Failure of Self-Extubation in the ICU
Official title: Unplanned-extubation in the Intensive Care Unit; Incidence, Characteristics and Prognosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unplanned Extubation
Self Extubation
Keywords: Self extubation
Unplanned extubation
intensive care unit
Lead sponsor: Société Française d'Anesthésie et de Réanimation
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 633
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with occurrence of an unscheduled extubation (auto-extubation or accidental extubation) in the ICU

Brief summary: Our study consists of a national observational study assessing quantitatively (incidence) and qualitatively unscheduled extubation in intensive care unit. In addition, we will compare the outcome of patients with "success" or "failure" in the self-extubation subgroup.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Mechanically ventilated with oral or nasotracheal intubation
* Occurrence of an unscheduled extubation (auto-extubation or accidental extubation)
* Extubation is defined as the removal of the orotracheal or nasotracheal tube with the impossibility of reinsertion of the same device.

Exclusion Criteria:

* Opposition to the use of personal data
* Pregnant women
* Person under protective custody or guardianship

Primary outcomes:
measure: Quantitative description
timeFrame: During stay in the ICU
Secondary outcomes:
measure: Qualitative description
timeFrame: During stay in the ICU
measure: re-intubation
timeFrame: During stay in the ICU
measure: Severe hemodynamic and respiratory events
timeFrame: One hour after extubation
measure: Length of stay in intensive care unit, the duration of mechanical ventilation and mortality
timeFrame: During stay in the ICU
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière- Département d'Anesthésie-Réanimation
Study officials:
affiliation: Hôpital La Pitié Salpêtrière - Paris
name: Jean-Michel CONSTANTIN, MD
role: STUDY_CHAIR
References: