louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04005313: Development and Application of Portable Multisensory Stimulation Device
Official title: Development and Application of Portable Multisensory Stimulation Device: Vibroacustic Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment
Keywords: Electromyographic activity
Neck pain
Electroencephalographic activity
dementia
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to develop the vibroacustic devices, and to compare the effects between vibroacustic device therapy and music therapy in adults with dementia or with neck pain. The immediate effect and long-term training effect would be assessed.

Detailed description: The outcome measures included functional assessment ( such as: range of motion, balance etc.) and neurolphysiological assessment (such as: electroencephalographic activity or electromyographic activity).

Eligibility criteria: Inclusion Criteria:

* mild to moderate Dementia
* age-matched healthy subjects

Exclusion Criteria:

* can not follow order

Primary outcomes:
measure: the electroencephalographic (EEG) activities ncluding Alpha, Beta, Theta, and Delta signals will be assessed in persons with mild to moderate dementia and healthy subjects.after sensory stimulation. .
timeFrame: one year
Secondary outcomes:
measure: The pressure pain threshold following multisensory stimulation will be assessed around cervical region.
timeFrame: one year
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Kwan-Hwa Lin
Study officials:
affiliation: Tzu Chi University
name: Chich-Haung Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beinert K, Englert V, Taube W. After-effects of neck muscle vibration on sensorimotor function and pain in neck pain patients and healthy controls - a case-control study. Disabil Rehabil. 2019 Aug;41(16):1906-1913. doi: 10.1080/09638288.2018.1451925. Epub 2018 Mar 21.
Clinical trial NCT02280213: Comparison Four Intubation Devices
Official title: Comparison of Tracheal Intubation Using the Miller, Macintosh, Phillips and Wis-Hipple Blades During Infant Resuscitation: A Randomized Crossover Simulation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for infant intubation during resuscitation with and without chest compressions.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* paramedics
* no clinical experience in infant intubation

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy.

Primary outcomes:
measure: Time to intubation
timeFrame: 1 day
Secondary outcomes:
measure: Success of intubation
timeFrame: 1 day
measure: Ease of Use
timeFrame: 1 day
measure: POGO score
timeFrame: 1 day
measure: Cormack-Lehane grading
timeFrame: 1 day
measure: dental compression
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03656913: Validation of Low Dose CT for Diagnosis of Urolithiasis
Official title: Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Urolithiasis in Children and Young Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nephrolithiasis
Ureterolithiases
Keywords: Kidney Stone
Renal
Renal Stone
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators have developed an extremely low dose renal computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of a single view abdominal radiograph. The investigators plan to test this exam in patients with known or suspected urolithiasis undergoing clinically indicated CT.


Eligibility criteria: Inclusion Criteria:

* Pediatric and young adult patients (ages 4 to \<21 years)
* Known or suspected urolithiasis
* Undergoing clinically indicated CT of the abdomen/pelvis

Exclusion Criteria:

* Pregnancy
* Prior enrollment in the same study (no patient will be enrolled more than once)

Primary outcomes:
measure: Diagnostic performance of extremely low dose CT
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center Burnet Campus
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Andrew T Trout, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01514513: Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin
Official title: A Comparative Study to Demonstrate the Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin in Head Lice Infested Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediculosis Capitis
Lead sponsor: South Florida Family Health and Research Centers
Sponsor class: NETWORK
First posted: 2012-01-23
Enrollment: 42
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in eradicating head lice as compared to Nix, both are available over-the-counter lice treatments.

Detailed description: Head lice is a worldwide problem. Many treatments for lice appear to be losing their effectiveness; therefore products are needed that safely and effectively eradicate lice.

Eligibility criteria: Inclusion Criteria:

* Must be 4 years of age or older

  * Must have an active head lice infestation of at least 10 lice and viable nits
  * Agree not used any other pediculicides or medicated products during the study
  * Agree not to use a nit comb during the study
  * Must have a single place of residence

Exclusion Criteria:

* Used any form of head lice treatment, prescription, OTC or home remedy for at least four weeks prior to their visit

  * Used topical medication of any kind on the hair for a period of 48 hours prior to visit
  * Individuals receiving systemic, topical drugs or medications which may interfere with the study results
  * Has a history of allergy or hypersensitivity to ragweed or any ingredient in either test products
  * Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with the evaluation
  * Females who are pregnant or nursing

Primary outcomes:
measure: The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice
timeFrame: 15 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 15 days
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Lice Source Services Inc.
state: Florida
Study officials:
affiliation: South Florida Family Health and Research Centers
name: Lidia Serrano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03455413: Quality of Perioperative Invasive Ventilation in PICU
Official title: Electrical Impedance Tomography (EIT) in Assessing the Quality of Perioperative Invasive Ventilation in PICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Ventilation
Elective Surgery
Keywords: electrical impedance tomography
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates and infants undergoing elective/semi-elective surgery

Brief summary: This is purely observational study in which quality of invasive ventilation is observed with electrical impedance tomography (EIT) during perioperative intensive care. EIT parameters will be used to assess if protective ventilation strategies are successfully followed during routine care.

Detailed description: 20 neonates and infants undergoing elective surgery and requiring postoperative treatment and follow up in PICU or in pediatric anestesiology clinic, will be included in this prospective observational study. Swisstom BB2-monitor and NeoSensorBelts will be used to monitor their ventilatory care from arrival to the operation room (prior intubation) to postoperative intensive care (until 2 hours after extubation). EIT parameters assessing lung aeration and ventilation distribution will be used to assess the quality of invasive ventilation.

Eligibility criteria: Inclusion Criteria:

* Written informed consent from a parent of legal guardian
* Infant undergoing elective or semi-elective surgery
* Postoperative admission to PICU expected
* Spontaneous breathing prior to study inclusion

Exclusion Criteria:

* Need for respiratory support prior to surgery
* Thoracic surgery
* Body weight \< 1500g or \> 10 kg

Primary outcomes:
measure: Silent spacies
timeFrame: 24 hours
Secondary outcomes:
measure: Ventilation distribution
timeFrame: 24 hours
measure: Effect of interventions on ventilatory parameters
timeFrame: 24 hours
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital and PEDEGO research group, University of Oulu
name: Merja Kallio, MD, PhD
role: STUDY_DIRECTOR
affiliation: Oulu University Hospital and PEDEGO research group, University of Oulu
name: Marika Rahtu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03577613: Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes
Official title: Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Keywords: radical hysterectomy
minimally invasive surgery
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a RH at our institution

Brief summary: Prospective controlled study (Canadian Task Force II-2) : Comparison analysis regarding surgical outcomes, complications, overall survival (OS), disease free survival (DFS) and cancer specific survival between patients subjected to radical Hysterectomy either by open radical hysterectomy (ORH) or minimally invasive surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).

Detailed description: Study Objective: To analyse the effect that the introduction of minimally invasive procedures has had on surgical and oncological outcomes when compared with conventional open radical hysterectomy (ORH) in a national reference cancer center Design: A prospective controlled study (Canadian Task Force II-2) Setting: A university teaching hospital Patients: All patients that underwent RH as primary treatment for cervical cancer in our institution between May 1999 and June 2016, with a total of 188 patients.

Interventions: Patients underwent an open radical hysterectomy (ORH) or minimally invasive surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer.
* Subjected to Radical Hysterectomy.

Exclusion Criteria:

* Pregnant women in which a RH was performed at the time of caesarean section.
* Previous chemotherapy treatment
* Previous pelvic radiotherapy

Primary outcomes:
measure: Overall survival.
timeFrame: up to 240 months
Secondary outcomes:
measure: Disease free survival
timeFrame: up to 240 months
measure: Cancer specific survival
timeFrame: up to 240 month
measure: surgical complication Rate
timeFrame: up to 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Vall D'Hberon
name: Antonio Gil-Moreno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03391713: The Effectiveness of Waiting Room Posters for Stroke Education
Official title: The Effectiveness of Waiting Room Posters in Improving Awareness and Knowledge of the Signs and Symptoms of Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Keywords: awareness
poster
stroke
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
First posted: 2018-01-05
Enrollment: 1064
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the effectiveness of posters in improving patient awareness and knowledge of the signs and symptoms of stroke. The control group study will be conducted in the first two weeks. Subsequently, the intervention arm will occur in the subsequent two weeks.

Detailed description: Stroke is a major health problem and a known cause of death and disability worldwide. In Malaysia, stroke is known to be top five causes of death and top ten causes of hospitalization Malaysia. Ischemic stroke accounts for more than 95% of all stroke cases (1). A recent study done in Malaysia showed that only 26% of patients with stroke symptoms presented to the hospital within 3 hours. One of the reasons was patients did not perceive the symptoms of stroke as being that of a serious illness (2). One of the modalities to raise awareness of stroke is through an educational poster. Posters in the waiting room can increase awareness of health promotion issues (3). Therefore, by placing poster regarding sign and symptoms of stroke in the waiting room in a government clinic, can increase awareness of early presentation of stroke.

Eligibility criteria: Inclusion Criteria:

* Adult age more than 18 years old and above
* Able to understand Malay
* Able to provide informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Awareness of the signs and symptoms of stroke
timeFrame: Within 24 hours
Secondary outcomes:
measure: Improvement in the knowledge of the need for a quick transfer to the hospital
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Klinik Kesihatan Kuala Lumpur
Study officials:
affiliation: University of Malaya
name: Su May Liew
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheah WK, Hor CP, Zariah AA, Looi I. A Review of Stroke Research in Malaysia from 2000 - 2014. Med J Malaysia. 2016 Jun;71(Suppl 1):58-69.
citation: Factors associated with delay in seeking treatment by patients with acute stroke: The National Neurology Registry (NNeuR) of Malaysia . Malinee Neelamegam1, Sharad Malavade1, Irene Looi2, Norsima Nazifah Sidek3, Zariah Abdul Aziz3. 2014
citation: Ward K, Hawthorne K. Do patients read health promotion posters in the waiting room? A study in one general practice. Br J Gen Pract. 1994 Dec;44(389):583-5.
Clinical trial NCT00205413: Surveillance For New Lung Primaries
Official title: Low Dose Helical Computed Tomographic (CT) Screening Followed by Anatomic Co-Registered Computed Tomography With Positron Emission Tomography (CT/PET) for Patients With Indeterminate (5-9 mm) Nodules
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Keywords: surveillance for lung cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This clinical research protocol proposes to perform low dose helical computed tomographic (CT) scanning in 250 high-risk patients (125/year for two years) in order to detect lung carcinomas when they are small and subject to effective curative therapies.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic

Exclusion Criteria:

* 20 pack year history

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Medical School
name: Tracey Weigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03467113: A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
Official title: An Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dravet Syndrome
Lennox Gastaut Syndrome
Keywords: Dravet Syndrome
LGS
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-03-15
Enrollment: 9
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).


Eligibility criteria: Key Inclusion Criteria:

* Subject has a clinical diagnosis of DS or LGS, where convulsive seizures (generalized tonic clonic seizures, tonic seizures, atonic seizures, tonic/atonic seizures, focal seizures with clear observable motor signs) are not completely controlled by current AEDs.
* All medications or interventions for epilepsy (including ketogenic diet \[KD\] and vagal nerve stimulation \[VNS\]) must be stable for at least 4 weeks prior to first ZX008 dose and are expected to remain stable throughout the study.
* Subjects must be taking a stable dose of CBD for at least 4 weeks prior to first ZX008 dose.
* Subject's source of CBD is expected to be consistent for at least 3 months during study participation.

Key Exclusion Criteria:

* Subject has current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke.
* Subject with current cardiac valvulopathy or pulmonary hypertension that the Investigator, parent/caregiver, Independent Cardiac Advisory Board, Independent Data and Safety Monitoring Committee, or sponsor deems clinically significant.
* Subject has a current or past history of glaucoma.

Primary outcomes:
measure: Adverse Events
timeFrame: Baseline to Day 365
measure: Change in Heart Rate
timeFrame: Baseline to Day 365
measure: Change in blood pressure
timeFrame: Baseline to Day 365
measure: Change in temperature
timeFrame: Baseline to Day 365
measure: Change in respiratory rate
timeFrame: Baseline to Day 365
measure: Changes in heart rhythm
timeFrame: Baseline to Day 365
measure: Changes in heart valve function
timeFrame: Baseline to Day 365
measure: Changes in treatment-emergent body weight and height
timeFrame: Baseline to Day 365
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: PANDA Neurology/CIRCA
state: Georgia
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
Study officials:
References:
Clinical trial NCT00189813: A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Potential Efficacy, Safety and Tolerability of Different Oral Doses of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Diarrhea
Nasea®
Irribow®
ramosetron
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Europe B.V.
First posted: 2005-09-19
Enrollment: 691
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.


Eligibility criteria: Inclusion Criteria:

* Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS

Exclusion Criteria:

* Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases
* Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Ceske Budejovice
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Ostrava Hrabuvka
country: Czech Republic
city: Praha
country: Czech Republic
city: Tabor
country: Czech Republic
city: Usti nad Orlici
country: Czech Republic
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Viljandi
country: Estonia
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Dietzenbach
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Friedberg
country: Germany
city: Hamburg
country: Germany
city: Hassloch
country: Germany
city: Koenigstein
country: Germany
city: Leipzig
country: Germany
city: Mainz
country: Germany
city: Marburg
country: Germany
city: Potsdam
country: Germany
city: Waltershausen
country: Germany
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Leszno
country: Poland
city: Lublin
country: Poland
city: Olawa
country: Poland
city: Warszawa
country: Poland
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Dnipropetrovsk
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Simferopol
country: Ukraine
city: Sumy
country: Ukraine
Study officials:
affiliation: Director of Late Phase Development
name: F. Verbeeck
role: STUDY_CHAIR
References: