louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04121104: Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation
Official title: Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Keywords: Spinal cord stimulation
Electrodermal activity
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is investigating skin conductance and respiration during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years old.
* Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.
* Cognitive and language functioning enabling coherent communication between the examiner and the participant.

Exclusion Criteria:

* Patients with impaired skin integrity at the fingers.
* Patients with major psychiatric problems.

Primary outcomes:
measure: Skin conductance changes
timeFrame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]
measure: Respiration rate
timeFrame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]
Secondary outcomes:
measure: Pain intensity scores using the Visual Analogue Scale
timeFrame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
city: Verviers
country: Belgium
facility: Clinique Ste Elisabeth
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Maarten Moens, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05044104: Wearable Technology in Endoscopy
Official title: A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Gastrointestinal Endoscopic Procedure with sedation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.

Detailed description: This is a prospective, non-blinded, exploratory study to assess the accuracy and safety of wearable devices in the endoscopy suite with patients undergoing procedures using anesthesia assisted sedation using smart watches. We will also simultaneously perform an assessment of patient and provider preferences using narrative-driven, qualitative evaluation.

Eligibility criteria: Inclusion Criteria:

* Adults over 18 years of age.
* Undergoing anesthesia-assisted endoscopic procedures.
* Able to give appropriate consent to the study or have an appropriate representative to do so.

Exclusion Criteria:

* Pregnancy.
* Physical deformity, wound, or dressing preventing placement of a wearable device on the wrist.
* Allergy to aluminum, nickel or acrylate.

Primary outcomes:
measure: Recorded Tachycardia Events
timeFrame: Anesthesia Duration, approximately 30 to 45 minutes
measure: Recorded Bradycardia Events
timeFrame: Anesthesia Duration, approximately 30 to 45 minutes
measure: Recorded Desaturation Events
timeFrame: Anesthesia Duration, approximately 30 to 45 minutes
measure: Recorded Arrhythmia Events
timeFrame: Anesthesia Duration, approximately 30 to 45 minutes
measure: Recorded Tachypnea
timeFrame: Anesthesia Duration, approximately 30 to 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vinay Chandrasekhara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03764904: Airway Ultrasound as a Predictor for Postextubation Stridor in Anterior Cervical Spine Surgery
Official title: Airway Ultrasound as a Predictor for Postextubation Stridor in Cervical Spine Surgery [Anterior Approach]: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postextubation Stridor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Thirty patients aged 18-60 years ASA Ⅰ and Ⅱ of both genders who are scheduled for elective anterior cervical surgery under general anesthesia in supine position for the first time will be enrolled in the study.

Brief summary: literature on use of the ultrasound (US) in extubation decisions in cervical spine surgery is scarce.The aim of this study will be to evaluate the utility of US as an aid for decision making for extubation in elective cervical spine surgery (anterior approach) operations and as a predictor for postextubation stridor in these operations


Eligibility criteria: Inclusion Criteria:

* surgeries associated with either exposure of more than three vertebral bodies,
* exposures involving the C2-C4 levels,
* blood loss exceeding 300 mL
* surgical time of more than five hours,

Exclusion Criteria:

* laryngotracheobronchial pathology,
* severe cardiorespiratory disease,
* admitted for redo-surgery
* intubated prior to operation
* Patient with anesthetic risk factors include Mallampati 3 or 4 and multiple intubation attempts

Primary outcomes:
measure: the correlation between the post procedural laryngeal air-column width difference [LACWD] as obtained by laryngeal US with occurrence of postextubation stridor
timeFrame: First 6 hours postoperatively
Secondary outcomes:
measure: Incidence of other airway complication as hematoma
timeFrame: Intraoperative pre-extubation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT00197301: Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy
Official title: Phase 1 Study to Examine the Safety and Efficacy of a Novel Liposomal Based Intranasal Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: Intranasal vaccination, Influenza
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious among the elderly. A Vaccine given as a nasal spray may improve compliance and local immunity.Liposomes are lipid particles that may serve as carriers for the vaccine and together they enhance the local immune response in mice when given as nasal spray.This study aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to the commercial muscular vaccine.


Eligibility criteria: Inclusion Criteria:Healthy young(20-45years old) and elderly(65-95 years old) volunteers -

Exclusion Criteria:Known allergy to eggs and to the flu vaccine, pregnant and breast feeding women, chronic viral carriers, recently hospitalized persons

-

Primary outcomes:
measure: Seroprotection
Secondary outcomes:
measure: Antibody levels
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Arie Ben Yehuda, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04860401: OxyPrem Validation Study
Official title: A Miniaturized Device to Non-invasively Measure the Oxygenation and Hemoglobin Concentration in the Brain Using Near-infrared Spectroscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tissue Oxygenation Measurement
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The precision of the novel diagnostic near-infrared spectroscopy (NIRS) device for the measurement of tissue oxygenation and hemoglobin concentration (OxyPrem) is assessed by repeated measurements. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.


Eligibility criteria: Substudy 1 (healthy adult volunteers)

Inclusion Criteria:

* Healthy adult
* Signed informed consent

Exclusion Criteria:

* Dense black hair at the location of measurement
* Neurological diseases.

Substudy 2 (preterm infants)

Inclusion Criteria:

* Pre-term neonates (gestational age at birth less than 37 weeks)
* Signed informed consent by at least one parent

Exclusion Criteria:

* Clinically instability
* Malformations

Primary outcomes:
measure: Standard deviation of repeated StO2 level measurements (precision)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital of Zurich
state: Zurich
Study officials:
affiliation: University of Zurich
name: Bucher, Prof.em.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105401: Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease
Official title: Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer

Brief summary: This study aims to describe hallucinations prevalence in a sample of patients affected by Parkinson's disease and consulting in an outpatient facility.

An unique one hour interview will be offered to volunteers patients. Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics.

The study hypothesis is that hallucinations prevalence in Parkinson's disease is underestimated and is higher than usually described in the scientific literature when all hallucinations modalities and minor hallucinatory phenomenons are searched for.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years-old
* Absence of opposition from the patient himself/herself or his/her legal representant for his/her participation to the study
* Patient without superior age limit with a diagnosis of Parkinson's disease made according to the UKPDSBB criteria (UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria)
* Outpatient consulting in neurology at the Charpennes'hospital

Exclusion Criteria:

* Opposition to the study
* Deafness or blindness which could compromise the interview

Primary outcomes:
measure: Hallucinations Prevalence
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité
Study officials:
affiliation: Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité
name: Jing XIE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02125201: Effectiveness of Intranasal Versus Intravenous Fentanyl in Preterm and Term Newborns for Pain Prevention
Official title: Effectiveness of Intranasal Versus Intravenous Fentanyl in Preterm and Term Newborns for Pain Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: intranasal fentanyl
newborn
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 21
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neonatal intensive care unit patients undergoes many painful procedures during their hospitalization. Effective pain control in such procedures as intubation, catheterization, central line insertion, chest tube insertion, etc. is an important part of treatment. Opioids administration is a common practice for acute pain prevention. Fentanyl is the preferred opioid due to it rapid onset and short duration of action.

Fentanyl may be given intravenously, transcutaneous transmucosal and intranasal. Intranasal administration is practiced for about 20 years. A rich vascular supply in a nose provides rapid absorption of the drug. This uninvasive root is now popular for pain prevention and treatment. There are about 20 trials with intranasal fentanyl administration to children from 6 month old to 18 years. The investigators did not find information about this way of administration in neonates.

In our pilot study the investigators want to check if intranasal administration of fentanyl is safe and effective in pain prevention in term and preterm neonates during invasive procedures and to compare it with intravenous route of administration.


Eligibility criteria: Inclusion Criteria:

Term and preterm neonates that require invasive procedures (elective or semielective intubation, central line insertion , chest drain or abdominal drain)

Exclusion Criteria:

1. Neonates with prolonged analgesic treatment before the procedure
2. Neonates with neurologic problem which can interact with pain assessment

Primary outcomes:
measure: Pain scale - N-PASS
timeFrame: before the intervention and till one our after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: NICU
Study officials:
affiliation: HaEmek Medical Center, Israel
name: Marina Peniakov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04686201: Development of Diabetes Mobile Application
Official title: Development of Diabetes Mobile Application "MyD App" To Improve Patient's Knowledge, Compliance and Control: An Interventional Study Among Uncontrolled Type 2 Diabetes Mellitus Patients in Kedah, Malaysia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: this study is to measure the effectiveness of a diabetes mobile application for improving patient's knowledge, compliance and diabetes control among uncontrolled Type 2 Diabetes Mellitus mellitus patients in Kedah

Detailed description: Specific Objective

1. To develop and validate a diabetes mobile-app (MyD-App) for patients with uncontrolled Type 2 Diabetes Mellitus.
2. To measure the effectiveness of a diabetes mobile application for improving knowledge, compliance and control using the newly developed and validated MyD-App among patients with uncontrolled Type 2 Diabetes Mellitus.

Hypothesis

1. There is an increased in patient's knowledge on diabetes after MyD-App usage.
2. There is an increased in patient's compliance on medication and treatment after MyD-App usage.
3. There is a diabetes control improvement (HbA1C \< 6.5% or HbA1C reduction ≥ 1%) among Type 2 Diabetes Mellitus patients in Kedah after MyD-App usage.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years old
* Diagnosed with type 2 diabetes mellitus by a registered medical doctor.
* Registered and actively follow up in the health clinics at selected districts. (actively follow up: follow up at the clinic for at least once in a year).
* Own a smartphone with the Android platform.
* HbA1C \>7%

Exclusion Criteria:

* GDM
* Illiterate
* Anemia / Thalassemia
* Not agree to be the sample for the study

Primary outcomes:
measure: Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application
timeFrame: 6 months
measure: Percentage of uncontrolled Diabetes Mellitus patients who have good compliance after using Diabetes Mobile Application
timeFrame: 6 months
measure: Percentage of uncontrolled Diabetes Mellitus patients who have good control diabetes after using Diabetes Mobile Application
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alor Setar
country: Malaysia
facility: Jabatan Kesihatan Negeri Kedah
state: Kedah
Study officials:
affiliation: Department of Community Health, Faculty of Medicine, Universiti Kebangsaan Malaysia
name: MOHD ROHAIZAT HASSAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01119001: A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis
Official title: A P300 Brain Computer Interface Keyboard to Control Assistive Technology for People With Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2010-05-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: People with Amyotrophic Lateral Sclerosis (ALS) will use a P300 based brain computer interface (BCI) keyboard to type in assistive technology devices. The results of this study will be compared with a previous study of a P300 BCI keyboard used by healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* Diagnosed with cerebral palsy, spinal cord injury, neuromuscular disease, or ALS that results in impaired hand and arm function making it difficult to manipulate objects (if at all) and requires help to prepare or modify activities
* Able to see the BCI display
* Able to give informed consent
* Able to understand and remember instructions concerning participation
* Able to communicate effectively at least with familiar conversation partners

Exclusion Criteria:

* Are unable to give informed consent.
* Are currently experiencing open head sores
* Have a history of photo-sensitive epilepsy
* Have a history of cognitive deficits requiring accommodation or special education services
* Are unable to sit without moving the head and neck for at least 15 minutes

Primary outcomes:
measure: Accuracy of Typing With a BCI Keyboard by ALS Patients.
timeFrame: 3 times over 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jane Huggins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson DE, Gruis KL, Huggins JE. A plug-and-play brain-computer interface to operate commercial assistive technology. Disabil Rehabil Assist Technol. 2014 Mar;9(2):144-50. doi: 10.3109/17483107.2013.785036. Epub 2013 Apr 16.
Clinical trial NCT03652701: Hair Up Prospective Study
Official title: Hair Up Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hair Loss
Lead sponsor: Shmuel Gonen Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the performance of Hair Up on female pattern hair shedding and regrowth. 58 adult female patients suffering from hair loss will be evaluated in a single center prospective study


Eligibility criteria: Inclusion Criteria:

* Women who report hair loss during the past 3 months prior to the study

Exclusion Criteria:

* Disorders and medications affecting hair loss/growth, pregnancy, scarring alopecia

Primary outcomes:
measure: Assessment of hair loss
timeFrame: 1 month
Secondary outcomes:
measure: Assessment of hair regrowth
timeFrame: 3 months
measure: Quality of life questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: