louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03999489: Study of the Psychometric Properties and a Measure of Utility Determinants ( the SF- 6D) in Patients With Early Inflammatory Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 708 patients with early inflammatory low back pain included in the French cohort DESIR

Brief summary: The general main objective of our study is to investigate the psychometric properties, the levels and determinants of the extent of SF- 6D utility in patients followed for recent back pain inflammatory disease.

The specific objectives are :

* Study the feasibility of the tool considering missing data, distribution, construct validity, reproducibility, sensitivity to change or clinically different groups (discriminative ability) the extent of SF -6D utility .
* Study the impact of socio-demographic characteristics, disease characteristics and quality of life, comorbidities at baseline on the measurement of utility and sensitivity to change.


Eligibility criteria: Inclusion Criteria:

* The patient should be given free and informed consent and signed the consent

  * The patient must be affiliated or beneficiary of a health insurance plan
  * patients aged 18 years and under 50
  * inflammatory back pain (buttocks , lumbar or thoracic spine )
  * fulfilling the criteria of Calin or Berlin (30,31)
  * duration of symptoms than three months and less than three years
  * symptoms suggestive of spondyloarthritis as assessed by the local investigator ( score≥5 on a numerical scale from 0 to 10 where 0 = no evocative and 10 = very suggestive of spondyloarthritis ) .

Exclusion Criteria:

* Another clearly defined spinal disease (eg discarthrose )

  * history of treatment with biotherapy
  * taking glucocorticoids allowed only in low dose of less than 10mg of prednisone daily and stable for at least four weeks before inclusion
  * Current or history anomalies that could interfere with the validity of informed consent and / or prevent a patient's optimal adhesion to the cohort (eg , alcoholism , mental illness) .

Primary outcomes:
measure: Level of utility measured by the SF-6D
timeFrame: baseline (0 months)
measure: Level of utility measured by the SF-6D
timeFrame: 6 months
measure: Level of utility measured by the SF-6D
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01681589: Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)
Official title: Relationship Between Attention and Emotional Regulation Post-TBI: Probing Neural Circuitry With Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: TBI
Traumatic Brain Injury
Rehabilitation
Therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to investigate the relationship between attention and emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the cognitive mechanisms of emotional processing in patients with TBI, and explore novel treatment strategies to improve emotional regulation using with transcranial direct current stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.

Detailed description: Thirty (30) individuals status post TBI with complaints of emotional dysfunction 6 months post-brain injury and Fifteen (15) healthy controls will participate in the study. The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30-45 minutes for 6 weeks as described below. The control group will receive sham-tDCS 20 minutes and computerized cognitive training for 30-45 minutes twice a week for 6 weeks (12 training sessions). The sham group will not receive real tDCS after completion of the study.

Eligibility criteria: Inclusion Criteria:

* Brain Injury at least 6 months prior
* Family or self-identification of cognitive or emotional difficulties
* Unchanged and stabilized medical treatment in the three weeks prior to the screening

Exclusion Criteria:

* Any social or medical problem that precludes completion of the protocol.
* Presence of focal motor deficits in the upper extremities.
* Comorbid psychiatric disease such as schizophrenia, or active substance abusers (except nicotine).
* History of craniectomy, active infection, or seizure activity beyond 1 week post-TBI.
* Complicating medical problems such as uncontrolled hypertension, diabetes with signs of neuropathy, and previous neurological illness such as head trauma, prior stroke, epilepsy or demyelinating disease, implanted neuromodulatory or electronic device, metal in head
* Pregnancy

Primary outcomes:
measure: Baseline Measures Before Treatment
timeFrame: Week 1
Secondary outcomes:
measure: Post Treatment Measures to Check Improvements
timeFrame: Week 8
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Prin Amorapanth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04823689: Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation
Official title: Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation : a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction
Emergencies
Anterior Shoulder Dislocation
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The anterior glenohumeral dislocation is frequently encountered in emergency medicine. It represents about 50% of the total dislocation and affects 1 resident for 10 000 in France.

In Nord Franche-Comte Hospital, 1 to 2 patients per day present this diagnosis in the emergency department, which requires reduction by external manoeuvres.

A retrospective study shows the interest of the ventral decubitus compared to dorsal decubitus reduction in the care of patients with anterior glenohumeral dislocation. None prospective study has already demonstrate the interest of the ventral decubitus compared to the dorsal decubitus in the reduction of anterior glenohumeral dislocation.

The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.


Eligibility criteria: Inclusion Criteria:

* Patients with radiological confirmed anterior glenohumeral dislocation
* Patient affiliated or entitled to a social security scheme
* Oral informed consent form

Exclusion Criteria:

* Glenohumeral fracture or vasculoneural lesion associated
* Dislocation for more than 12 hours
* Homolateral shoulder surgery antecedent
* Contraindication to other analgesics (morphine, sedation)
* BMI \> 40
* Patient \< 18 year
* Pregnancy or nursing woment
* Person under guardianship or curatorship

Primary outcomes:
measure: The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of the success rate of the ventral decubitus technique compared to the dorsal decubitus technique
timeFrame: 1 day
measure: Evaluation of the consumption of sedative and analgesic treatments
timeFrame: 1 day
measure: Evaluation of the time spent in emergency department
timeFrame: 1 day
measure: Evaluation of the pain felt before and after the intervention
timeFrame: 1 day
Other outcomes:
Locations:
city: Belfort
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References:
Clinical trial NCT04159389: Mental Visualization as a Learning Tool in Anesthesia
Official title: Learning Mental Visualization to Improve Performance in Anesthesia: a Randomized Controlled Trial by Simulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Medical Education
Keywords: airway management
pedagogy
learning process
mental visualization
rapide sequence induction
Lead sponsor: University Grenoble Alps
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the benefit of adding mental visualization to a training program in medical education. Undergraduate medical students will be randomized before participating in a training program on airway management during rapid sequence induction. In the control group, participants will receive traditional teaching including theoretical courses and procedural simulation. In the intervention group, in addition to traditional teaching, participants will be trained and encouraged to practice mental visualization. The main outcome will be clinical performance during a standardized high-fidelity simulation of rapid sequence induction assessed using a specific pre-established checklist.


Eligibility criteria: Inclusion Criteria:

* Undergraduate medical students from the Grenoble Alps university hospital
* From the 2nd to the 6th year
* Volontary

Exclusion Criteria:

* /

Primary outcomes:
measure: Clinical performance for airway management in a standardized high-fidelity simulation of rapid sequence induction.
timeFrame: 2 weeks
Secondary outcomes:
measure: "Material preparation" score, subpart 1 of the clinical performance grid
timeFrame: 2 weeks
measure: "Intubation procedure" score, subpart 2 of the clinical performance grid
timeFrame: 2 weeks
measure: Physiological stress response : SDNN
timeFrame: 2 weeks
measure: Psychological stress response : Stress-VAS
timeFrame: 2 weeks
measure: Psychological stress response : STAI
timeFrame: 2 weeks
measure: Adesion to Mental visualization
timeFrame: 2 weeks
measure: Quality to Mental visualization : MIQ
timeFrame: 2 weeks
measure: Memorization of key messages at three months
timeFrame: 3 months
Other outcomes:
Locations:
city: La Tronche
country: France
facility: University Grenoble Alps
Study officials:
References:
Clinical trial NCT01095289: Electromyographic Activity of Masseter Muscle During Deglutition in Total Laryngectomized Subjects
Official title: Electromyographic Activity of Masseter Muscle During Deglutition in Total Laryngectomized Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: electromyography
laryngeal neoplasms
masticatory muscles
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2010-03-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 16 subjects underwent total laryngectomy

Brief summary: The objective of this study is to evaluate the electromyographic activity of masseter muscle during deglutition in laryngectomized subjects.


Eligibility criteria: Inclusion Criteria:

* laryngectomy

Exclusion Criteria:

* neurological diseases
* no oral feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Cancer Hospital of Pernambuco
state: PE
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Leandro Pernambuco, Graduated
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pernambuco Lde A, Silva HJ, Nascimento GK, Silva EG, Balata PM, Santos Vda S, Leao JC. Electrical activity of the masseter during swallowing after total laryngectomy. Braz J Otorhinolaryngol. 2011 Sep-Oct;77(5):645-50. doi: 10.1590/s1808-86942011000500018.
Clinical trial NCT03368989: The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.
Official title: The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bony Metastases From Castrate Refractory Prostate Cancer
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 21
Sex: MALE
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: Males presenting with prostate cancer.

Brief summary: To describe the changes seen on bone scan and correlate them with changes in relative chemical biomarkers, patient's functional status and level of pain.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer patients scheduled for treatment with Radium-223.

Exclusion Criteria:

* Patients not completing their treatment regimen for any reason

Primary outcomes:
measure: Change in number of osteoblastic bone lesions
timeFrame: Pretreatment (about 30 days before treatment) and post treatment (about 4 weeks after treatment)
Secondary outcomes:
measure: functional status as indicated by score on the Eastern Cooperative Oncology Group (ECOG) performance scale
timeFrame: Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments
measure: pain level as assessed by numeric rating score
timeFrame: Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments
measure: (PSA) prostate specific antigen level
timeFrame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
measure: (ALP) alkaline phosphatase level
timeFrame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
measure: Hemoglobin level
timeFrame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
measure: Platelet level
timeFrame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
measure: Neutrophil count
timeFrame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
measure: Creatinine level
timeFrame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
measure: white blood cell count
timeFrame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Isis W Gayed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04532489: Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Official title: Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Radiotracer
Hypertension
Cholesterol
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that \[18F\]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.

Detailed description: Following the results of radiation dosimetry from this study then next steps will be taken for groups 2 \& 3 using hormone manipulation.

Eligibility criteria: Inclusion Criteria:

* Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes

Exclusion Criteria:

* Pregnancy
* Unable to do imaging
* Body weight greater than 400 lbs (181 Kg)
* Prisoners are not eligible
* Subjects unable to provide own consent are not eligible
* Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)/ Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues.
* Known adrenal pathology

Primary outcomes:
measure: Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ben Viglianti, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01853189: Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: pediatrics
asthma
osteopathic manipulative treatment
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
First posted: 2013-05-14
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Asthma is a highly prevalent chronic disease in children. Complementary and Alternative Medicine research on asthma showed a potential effect on pediatric patients.

Studies looking at the effect of Osteopathic Manipulative Treatment seems to reveal positive results.

The aim of study is to further explore the role of OMT on asthma in a pediatric population.


Eligibility criteria: Inclusion Criteria:

* children with asthma age between 5 and 14

Exclusion Criteria:

* associated co-morbities surgical patients

Primary outcomes:
measure: Difference in Forced expiratory volume in the 1st second (FEV1) before and after OMT
timeFrame: Participants will be assessed at entry, after 3 and 6 months.
Secondary outcomes:
measure: Difference in fractional exhaled nitric oxide (FeNO) before and after OMT
timeFrame: Participants will be assessed at entry, after 3 and 6 months.
measure: Difference in percentage of hemoglobin saturation before and after OMT
timeFrame: Participants will be assessed at entry, after 3 and 6 months.
measure: Difference in Pediatric Asthma Quality of Life Questionnaire (PAQOL) before and after OMT
timeFrame: Participants will be assessed at entry, after 3 and 6 months.
measure: Differences in the number, type and quality of somatic dysfunctions
timeFrame: Participants will be assessed at entry, after 3 and 6 months
measure: Difference in peak expiratory flow (PEF) before and after OMT
timeFrame: Participants will be assessed at entry, after 3 and 6 months.
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Santo Spirito Hospital
state: Abruzzo
Study officials:
References:
Clinical trial NCT03836989: Electrical Stimulation to Promote Recovery in Bells Palsy
Official title: Pilot Clinical Trial to Study Facial Electrical Stimulation to Promote Recovery in Patients With Bell's Palsy and Poor Prognostic Factors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bell Palsy
Keywords: Facial Paralysis
Bell Palsy
Electrical Stimulation
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A feasibility pilot study to exam the necessary methodology for conducting a larger clinical trial for Bell's Palsy patients with a poor prognosis and the use of electrical stimulation.

Detailed description: Here we describe a protocol for a prospective, randomized, double-blinded study to evaluate the effects of monophasic pulsed current ES on patients with Bell's palsy and factors predicting poor recovery, with a 6 month follow up. Motor level stimulation with a pulse duration of 100 μsec and a frequency of 35 pulses per second were chosen from focus group with physical therapist to treat facial paralysis and are consistent with clinical trials showing motor benefit after capel tunnel surgery.

Eligibility criteria: Inclusion Criteria:

* New diagnosis of bell's palsy (diagnosed in the last 30 days)
* IF younger than 60 years of age must have complete paralysis on one side of face or both
* IF older than 60 years of age paralysis must be present but CAN be incomplete.

Exclusion Criteria:

* Paralysis associated with any of the fallowing: cancer, tumor, surgery, stroke, or trauma.
* Younger than 60 years old with INCOMPLETE paralysis.
* Non English speakers
* Pacemaker or deep brain stimulator

Primary outcomes:
measure: Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions
timeFrame: 3 months
Secondary outcomes:
measure: House Brackmann Scale
timeFrame: Baseline, and 3 months
measure: Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ)
timeFrame: Baseline, 3 months and 6 months
measure: Patient Reported Global Quality of Life Specific to Facial Paralysis
timeFrame: Baseline, 3 months and 6 months
measure: Objective Measurements of Brow Elevation
timeFrame: Baseline and in 3 months
measure: Eye Closure
timeFrame: Baseline and 3 months
measure: Smile Excursion
timeFrame: Baseline and 3 months
measure: Facial Symmetry at Rest
timeFrame: Baseline and 3 months
measure: Facial Symmetry During Smile
timeFrame: Baseline and 3 months
measure: Patient Tolerability
timeFrame: 3 months
measure: Self Reported Subject Adherence
timeFrame: 3 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Myriam D Loyo, MD
role: PRINCIPAL_INVESTIGATOR
References: