louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00730977: A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device
Official title: A Pilot Study to Investigate the Tolerability of Inhaled Dry Powder Mannitol (IDPM) Administered Via a Novel Dry Powder Inhaler Device in Healthy Individuals and Subjects With Bronchiectasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Bronchiectasis
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A novel dry powder inhaler device will be used to administer mannitol to healthy subjects and subjects with bronchiectasis in single doses higher than previously given.The main objective is to assess tolerability of these doses using the new device.


Eligibility criteria: Inclusion Criteria:

* healthy or bronchiectatic; 18 years and over

Exclusion Criteria:

* uncontrolled asthma, unstable

Primary outcomes:
measure: tolerability
timeFrame: immediately and 10 mins post dose
Secondary outcomes:
measure: respiratory symptoms, FEV1
timeFrame: pre-dose, immediately and 10 mins post dose
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
Study officials:
References:
Clinical trial NCT06675877: Impact of Virtual Reality on Pediatric Patients with ESRD on Regular Hemodialysis Through Arteriovenous Fistula.
Official title: Impact of Virtual Reality on Pain, Anxiety and Depression in Pediatric Patients with ESRD on Regular Hemodialysis Through Arteriovenous Fistula.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Anxiety
Keywords: VR
pediatric
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the child lay on the bed and wore virtual reality eyeglasses, the eyeglasses were placed on the child's head, the child watched 3 D VR kids' cartoons or videos to distract his/her attention during needle insertion. The video was displayed through a smart phone inserted inside the virtual reality headset.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This case control study will be conducted to study the effectiveness of Virtual Reality technique on pain during arteriovenous cannulation and on reduction of anxiety and depression in Pediatric Patients with ESRD undergoing regular hemodialysis through arteriovenous fistula.

Detailed description: This case control study will be conducted at nephrology and dialysis Unit Pediatric Department Tanta University Hospital (TUH) for a period of 6 months starting from April 2024.This study will be conducted on convenient sample of 60 participants. they will be classified as follow group A (cases) Group B (controls)each group will contain 30 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly at our nephrology Unit at TUH during the period of the study

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with end stage renal disease aged from 8 to 18 years on regular hemodialysis through functioning arteriovenous fistula and are fully oriented with time, persons and place at time of data collection. All participants either cases or controls suffer from anxiety, depression or both.

Exclusion Criteria:

* Children with temporary or permanent catheter for dialysis.
* Children with mental illness, visual and auditory defects.
* Children took any pharmacological pain reliever or antipsychotic drugs.
* Non anxious or depressed Children.

Primary outcomes:
measure: SCARED for anxiety Screen for Child Anxiety Disoders {SCARED} Child, parent version: It is a self-report screening questionnaire for anxiety disorders during hemodialysis
timeFrame: 6 months
Secondary outcomes:
measure: The Children's Depression Inventory scale for depression during hemodialysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
Study officials:
affiliation: Tanta university hospital
name: sara Ma ElGhoul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00719277: Feasibility Study: Sleuth Monitoring System
Official title: Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arrhythmia
Syncope
Keywords: cardiac arrhythmia
syncope
ECG
implantable ECG monitor
ILR
Lead sponsor: Transoma Medical
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.


Eligibility criteria: Inclusion Criteria:

* Age \> = 18 years at time of enrollment
* Either of the following:

  1. MI \> 30 days prior to enrolment and LVEF \< = 35% by echocardiography (or nuclear imaging as necessary)
  2. Syncope of unknown etiology

Exclusion Criteria:

* Life expectancy \< 12 months following enrollment
* Active infection

Primary outcomes:
measure: Diagnostically viable ECG signals
timeFrame: daily
Secondary outcomes:
measure: rate of device-related adverse events
timeFrame: 1, 6, and 12 months
Other outcomes:
Locations:
city: Panama city
country: Panama
facility: Hospital Paitilla
Study officials:
affiliation: Transoma Medical
name: Wim Stegink
role: STUDY_DIRECTOR
References:
Clinical trial NCT06795477: Preventing Medication Dispensing Errors in Pharmacy Practice with Interpretable Machine Intelligence: Wave 2
Official title: Preventing Medication Dispensing Errors in Pharmacy Practice with Interpretable Machine Intelligence: Wave 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Machine Intelligence in the Pharmacy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2025-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Pharmacists currently perform an independent double-check to identify drug-selection errors before they can reach the patient. However, the use of machine intelligence (MI) to support this cognitive decision-making work by pharmacists does not exist in practice. This research is being conducted to examine the effectiveness machine intelligence (MI) advice on to determine if its impact on pharmacists' work performance and cognitive demand.


Eligibility criteria: Inclusion Criteria:

1. Licensed pharmacist in the United States
2. Age 18 years and older at screening
3. PC/Laptop with Microsoft Windows 10 or Mac (Macbook, iMac) with MacOS with Google Chrome or Firefox web browser installed on the device
4. Screen resolution of 1024x968 pixels or more
5. A laptop integrated webcam or USB webcam is also required for the eye tracking purpose.

Exclusion Criteria:

1. Eyeglasses with more than one power (bifocals, trifocals, progressives, layered lenses, or regression lenses)
2. Cataracts, intraocular implants, glaucoma, or permanently dilated pupil
3. Require a screen reader/magnifier or other assistive technology to use the computer
4. Eye surgery (e.g., corneal)
5. Eye movement or alignment abnormalities (lazy eye, strabismus, nystagmus)

Primary outcomes:
measure: Cognitive effort
timeFrame: 1 day - Single study visit
measure: Decision accuracy
timeFrame: 1 day - Single study visit
measure: Trust change
timeFrame: 1 day - Single study visit
Secondary outcomes:
measure: Reaction time
timeFrame: 1 day - Single study visit
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT01475877: Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy
Official title: Bromday (Bromfenac Ophthalmic Solution)0.09% QD vs Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Control of Pain and Epithelial Healing Post (PRK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: bromfenac
nepafenac
PRK
epithelial healing,
Lead sponsor: Virdi Eye Clinic
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing photorefractive keratectomy in both eyes

Brief summary: This study will compare the effect of two topical non-steroidal antiinflammatory agents to control pain after photorefractive keratectomy (PRK) eye surgery.


Eligibility criteria: Inclusion Criteria:

* male or female at least 18 years of age,
* no other ocular studies with 15 days prior to dosing,
* BCVA 20/200 or better,
* return for study visits and follow instructions from investigator and staff,
* self administer test article

Exclusion Criteria:

* Ocular inflammation,
* hypersensitivity to bromfenac or nepafenac,
* any corneal pathology,
* have had radial keratotomy,
* corneal transplant or corneal refractive surgery in the last two years

Primary outcomes:
measure: Post-PRK pain
timeFrame: 7 days
Secondary outcomes:
measure: Post-PRK epithelial healing
timeFrame: 7 days
Other outcomes:
Locations:
city: Rock Island
country: United States
facility: Virdi Eye Clinic and Laser Vision Center
state: Illinois
Study officials:
affiliation: Virdi Eye Clinic
name: Navaneet S Borisuth, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00675077: Far Infrared Irradiation for Managing, Control and Treatment of Huntington's Disease (HD)
Official title: Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Control, Management and Treatment of HD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Huntington Disease
Keywords: Akinetic-Rigid Variant of Huntington Disease
Chorea, Chronic Progressive Hereditary (Huntington)
Chronic Progressive Hereditary Chorea (Huntington)
Huntington Chorea
Huntington Chronic Progressive Hereditary Chorea
Huntington Disease, Akinetic-Rigid Variant
Huntington Disease, Juvenile
Huntington Disease, Juvenile-Onset
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Huntington's disease (HD) is a fatal disease with profound neurological and behavioral features. HD is typically characterized by uncontrollable movements and psychological disturbances.

This study will investigate the use of far infrared radiation for control, management and treatment of HD.

Detailed description: Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have HD.

Eligibility criteria: Inclusion Criteria:

* People with HD

Exclusion Criteria:

* None

Primary outcomes:
measure: Treatment of people with HD
timeFrame: 2 years
Secondary outcomes:
measure: Rehabilitation of people with HD
timeFrame: 2 Years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03961477: Effect of Interferential l Therapy on Low Back Pain
Official title: Effect of Interferential Therapy on Pain, Range of Motion and Quality of Life in Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain,
Interferential Therapy
Quality of Life
Lead sponsor: Ahlia University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-05-23
Enrollment: 61
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Chronic non-specific low back pain is defined as unknown mechanical musculoskeletal pain lasting more than 3 months. Electrotherapy is a non-pharmacologic, non-invasive and simple method back pain treatment that is mainly applied using interferential (IF) therapy. The current study was designed to investigate the effect of IF on pain, range of motion, and quality of life in patients with chronic non-specific low back pain. Materials and methods: 61 patients suffered from chronic non-specific low back pain (CNLBP) were randomly assigned to IF group (n=30) and placebo IF (n=31). The entire patient received suggested exercise 3 times per week for 4 weeks. The outcome measures were visual analogue scale (VAS), lumbar range of motion (ROM) in terms of flexion\& extension and the Short Form-36 (SF-36) health questionnaire to evaluate the quality of life (QOL).

Detailed description: Participants The study was conducted in outpatient clinics in Cairo University Hospitals. 60 patients (29 males and 31 females) were invited to participate in the current study. Subjects were included in the study if they had LBP of at least three months duration and aged between 25 and 60 years. Patients with spinal pathology (tumor, nerve root, fracture, and compromise), cardiopulmonary conditions, pregnancy, and received physiotherapy in the last eight weeks or any contraindications to the use of electrotherapy were excluded.

Eligibility criteria: Inclusion Criteria:

\*Subjects were included in the study if they had LBP of at least three months duration \* Age between 25 and 60 years.

Exclusion Criteria:

* Patients with spinal pathology (tumor, nerve root, fracture, and compromise),
* Cardiopulmonary conditions
* Pregnancy,
* Received physiotherapy in the last eight weeks
* Any contraindications to the use of electrotherapy were excluded.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Dr Dalia Kamel
city: Giza
country: Egypt
facility: Dr Sayed Tanatwy
Study officials:
affiliation: Cairo University
name: Sayed A Tantawy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06086977: Pulse Analysis for Cholecystitis Patients Before and After Cholecystectomy
Official title: Pulse Analysis for Cholecystitis Patients Before and After Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystitis
Cholecystectomy
Keywords: radial pressure pulse (RPP)
Lead sponsor: Taichung Tzu Chi Hospital
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cholecystitis and recieve cholecystectomy

Brief summary: The aim of this study is to record the radial pressure pulse(RPP) of the patients with cholecystitis compared preoperative and postoperative pulse changes in an attempt to determine the relationship between cholecystitis and pulse.

Detailed description: A total of 20 patients were recruited according to the inclusion and exclusion criteria. The patients, aged 32-76 years, were given a diagnosis of cholecystitis by a general surgeon from Taiwan's Taichung Tzu Chi Hospital. All eligible patients included in the study agreed to participated and signed the informed consent form and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-12). By measuring and recording the RPP preoperatively and postoperatively, the mean values of the spectral energy (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) were obtained for comparison with the preoperative white blood cell (WBC) count.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with acute or chronic cholecystitis
2. Patient hospitalized for cholecystectomy
3. Patients who were voluntarily involved in this study

Exclusion Criteria:

1. Patients who could not cooperate with pulse diagnosis
2. Patients with underlying systemic diseases such as cancer, chronic obstructive pulmonary disease, cardiac failure, chronic renal failure, cirrhosis, etc.

Primary outcomes:
measure: The changes of spectral energy of radial artery pulse after cholecystectomy
timeFrame: Baseline (before cholecystectomy) and 24 -48 hours after cholecystectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: TZU CHI Hospital
Study officials:
References:
Clinical trial NCT04565977: Evaluating Off-label Use of Direct Oral Anticoagulants (DOACs) in Hypercoagulable States
Official title: Evaluating Off-label Use of Direct Oral Anticoagulants (DOACs) in Hypercoagulable States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercoagulable States
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019

Brief summary: Retrospective, cohort study chart review in patients with hypercoagulable states.

Detailed description: * Retrospective, cohort study chart review in patients at Methodist Health System
* Data will be pulled on all patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 year-old
* Patients with diagnosis of hypercoagulable state identified by ICD-9/ICD-10 codes
* Patients who were prescribed DOACs or VKA for primary or secondary prevention of thrombosis

Exclusion Criteria:

* Patients with FDA-approved indications of oral anticoagulants including atrial fibrillation or treatment/prevention of thrombotic events unrelated to specified hypercoagulable states
* Patients with incomplete electronic medical records

Primary outcomes:
measure: Rates of thrombotic events during the study period
timeFrame: Jan 1,2015 - Dec 31st, 2019
measure: Rates of hemorrhagic events during the study period
timeFrame: Jan 1,2015 - Dec 31st, 2019
Secondary outcomes:
measure: Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states
timeFrame: Jan 1,2015 - Dec 31st, 2019
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Valerie Vuylsteke, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01763177: Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat
Official title: Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: nebulizer
oxygen
post-operative sore throat
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 1036
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Rationale: Delivery dry gas during anesthesia is associated with post-operative sore throat (POST). Oxygen nebulizer therapy increases humidity to the airway, especially post-extubation.

Objective: To investigate the effect and complications of oxygen nebulizer therapy on POST.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Pre-operative Hb \>10 g% or Hct \> 30%
* American Society of Anesthesiologist (ASA) class I-III
* Elective surgery
* General anesthesia with oroendotracheal tube using Macintosh laryngoscope
* Not exposed to intraoperative nitrous oxide
* Oxygen saturation at room air \> 95% before induction and at arrival the PACU

Exclusion Criteria:

* Cases needing ICU admission immediately post-operative
* Conditioning requiring post-operative oxygen therapy e.g. heart disease, pregnancy, morbid obesity, cardiac and thoracic surgery
* Patients' conditioning affecting to complication of nebulizer oxygen therapy e.g. pulmonary disease, bleomycin treatment
* Patient's conditioning affecting POST assessment e.g. pre-operative using ventilator, recent upper respiratory tract infection (URI), recent lower respiratory tract infection and history of difficult airway
* Surgical conditioning affecting POST e.g. airway surgery, oral surgery, esophageal and neck surgery

Primary outcomes:
measure: The effect of oxygen nebulizer therapy on post-operative sore throat
timeFrame: at post-anesthetic care unit and 24-h post-operative
Secondary outcomes:
measure: To evaluate the adverse events (pulmonary complications, wound infection, and mortality) of post-operative complications related to oxygen therapy
timeFrame: 24-h post-op and 30-d mortality
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Department of anesthesiology, Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
name: Panthila Rujirojindakul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: oxygen nebulizer AND sore throat
Clinical trial NCT01054677: Swedish Antibiotic Nursing Home Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Urinary Tract Infections
Keywords: Infections in nursing homes
especially urinary tract infections
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The national corporation of Swedish pharmacies, Apoteket AB
First posted: 2010-01-22
Standard ages: CHILD
ADULT
OLDER_ADULT
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Main aim and objective

The aim was to present the treatment of infectious diseases in elderly, especially in nursing homes and further to evaluate the effect of an intervention package aiming at improving treatment with antibiotics in Swedish nursing homes

Specific objectives

* Present the treatment patterns regarding infectious diseases, including gender aspects in elderly, especially in nursing homes.
* Through focus group discussions elucidate the decision making process in nursing homes and target the intervention.
* Based on the above information develop an educational intervention to contribute to the improvement of the prescribing of antibiotics in nursing homes
* Evaluate the effect of the intervention on quality of prescribing, knowledge and attitudes in relation to available guidelines


Eligibility criteria: Inclusion Criteria:

* nursing homes where residents have a common dining room and staff, and a self-assessed stable staff situation

Exclusion Criteria:

* specialised nursing homes or wards (e.g. oncology wards)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: