louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06993441: Music and Symptom Relief in Radiotherapy Patient
Official title: Effects of Music on Pain, Anxiety and Stress Levels in Cancer Patients Receiving Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Therapy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled study aims to evaluate the effects of music therapy administered during radiotherapy sessions on pain, stress, and anxiety levels in cancer patients. The intervention involves playing Musicure, a therapeutic music track, for 30 minutes via speakers during radiotherapy. The study includes two groups: an intervention group receiving music therapy and a control group receiving standard care without music.

Participants' pain levels were assessed using the Visual Analog Scale (VAS), while anxiety and stress levels were measured using the Face Anxıety Subscale ( FAS).

A total of 120 adult cancer patients undergoing outpatient radiotherapy at Tınaztepe Unıversty were included. The study was conducted under the supervision of Dr. Öğr. Üyesi \[Duygu AKBAŞ UYSAL (Principal Investigator) and co-researchers Prof.Dr Fsun ŞENUZUN AYKAR, Prof.Dr Zümra ARICAK ALICIKUŞ The research complies with ethical standards and has received approval from \[insert name of ethics committee\].

This study investigates a low-cost, non-pharmacological intervention that has the potential to improve symptom management and quality of life in cancer patients.


Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the study,
* 18 years of age and older,
* No hearing problems,
* No communication and speech problems

Exclusion Criteria:

* Those diagnosed with psychiatric and neurological diseases,

Primary outcomes:
measure: Pain Level
timeFrame: Baseline (before radiotherapy on Day 1) and immediately after the radiotherapy session on Day 1.
Secondary outcomes:
measure: anxiety level
timeFrame: Baseline (before radiotherapy on Day 1) and immediately after the radiotherapy session on Day 1.
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Tinazetepe Bayrakli Hospital
state: İ̇zmi̇r
Study officials:
References:
Clinical trial NCT02082119: Hypofractionated IMRT With Temozolomide for HGG
Official title: Hypofractionated IMRT (VMAT-RA) With Temozolomide for Patients With Newly Diagnosed High Grade Glioma (HGG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioma
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed HGGs after surgery.

Primary endpoint: progression free survival (PFS), Overall Survival (OS) and Toxicity.

Secondary endpoint: to evaluate Quality of life (QoL) of patients after surgery, concomitant chemoradiotherapy and adjuvant chemotherapy through neuropsychological examination.

Detailed description: We designed a study of a hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc approach. The potential advantage of this approach is to deliver a more selective irradiation to tumor's target with reducing dose to normal brain and to allow to deliver a higher dose, optimizing the therapeutic window

Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years
* Karnosky performance status (KPS) ≥60
* Patients aged \>70 years with KPS ≥80
* Histopathologically confirmed of HGG
* Estimated survival ≥ 3 months.
* Multifocal tumor
* Normal liver, Kidney and bone marrow function
* Written informed consent

Exclusion Criteria:

* Prior radiation therapy
* KPS ≤ 60
* Age \> 70 years and KPS \< 70
* Other primary cancer
* Pregnant women

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life (QoL) of Patients After Surgery, Concomitant Chemo-radiotherapy and Adjuvant Chemotherapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Clinico Humanitas
Study officials:
affiliation: Humanitas Cancer Center
name: Piera Navarria, MD
role: STUDY_DIRECTOR
References:
citation: Reddy K, Damek D, Gaspar LE, Ney D, Waziri A, Lillehei K, Stuhr K, Kavanagh BD, Chen C. Phase II trial of hypofractionated IMRT with temozolomide for patients with newly diagnosed glioblastoma multiforme. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):655-60. doi: 10.1016/j.ijrobp.2012.01.035. Epub 2012 Apr 5.
Clinical trial NCT05615519: Validation of a Smartphone-based Intelligent Diagnosis and Measurement for Strabismus
Official title: Validation of a Smartphone-based Intelligent Diagnosis and Measurement for Strabismus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Strabismus
Exotropia
Esotropia
Vertical Strabismus
Keywords: Mobile health
Artificaial intelligence medicine
Pediatric ophthalmology
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients from strabismus \& optometry departments or participants from the internet.

Brief summary: The current measurement methods of strabismus include the corneal light reflection method, prism alternate covering, etc., which especially rely on the subjective experience of doctors, and there is a large error between different measurers， leading to serious underestimation of strabismus prevalence and insufficient care for strabismus patients. Here, the investigators established and validated an artificial intelligence system to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests. Three-dimensional reconstruction methods are used to digitize the parameters of head and eye positions. This system has been integrated into a smartphone platform to be further validated through hospital-based and population-based clinical trials.


Eligibility criteria: Inclusion Criteria:

The quality of facial videos should be clinically acceptable.

Primary outcomes:
measure: The effectiveness of smartphone-based diagnosis
timeFrame: Baseline
measure: The consistency between manual and smartphone measurement
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
References:
Clinical trial NCT01985919: Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
Official title: Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: No Restrictions on Diagnosis
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and females, 18 years of age and older who are scheduled to undergo a bone marrow aspirate and/or bone marrow biopsy as part of their participation on another research study, who are allowing their samples to be collected and used for research purposes, and/or who might benefit from the administration of moderate sedation. Therefore, there are no restrictions with regards to diagnosis, though most patients will have hematologic malignancies (leukemia, lymphoma, myeloma, amyloidosis, myelodysplastic syndromes, myeloproliferative diseases).

Brief summary: This clinical research protocol is intended to allow for bone marrow aspirate/biopsy and blood specimens to be collected for research purposes, specifically allowing subjects the option of sedation during the bone marrow procedure. Samples will be banked for future research related to cancer and other diseases. Researchers hope this protocol will improve the collection of research correlative and translational biopsy specimens for clinical research.


Eligibility criteria: Inclusion Criteria:

* Planned procedure including a bone marrow aspirate and/or bone marrow biopsy
* The procedure is planned for the purpose of obtaining a research specimen (as part of another research study or as part of this stand-alone sample collection protocol.). Procedures with a dual purpose (i.e. to obtain both clinically-indicated specimens and research specimens) are permitted, but procedures to obtain clinical specimens only are not permitted.
* All subjects must provide written informed consent for the biopsy procedure, the collection of bone marrow and blood specimens for research purposes and (if planned) the administration of sedation.

Exclusion Criteria:

* Moderate sedation may not be administrated to subjects with a clinical contraindication to its provision, or if the investigator believes that administration of moderate sedation would constitute under risk to the subject.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center
name: Dan Vogl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01857219: A Brain Imaging Study of Tai Chi on Fibromyalgia
Official title: A Brain Imaging Study of Tai Chi on Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: fMRI
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To accomplish our Specific Aims, we propose to conduct a two-session fMRI experiment in up to 30 patients with fibromyalgia (FM) and up to 30 healthy controls. All subjects will be invited to complete the second, identical fMRI session about 3 months following completion of the first session. Fibromyalgia subjects will complete their scans before and after a 12-week Tai Chi intervention in collaboration with Tufts Medical Center.


Eligibility criteria: Criteria for fibromyalgia patients.

Inclusion Criteria:

* Volunteers 18-50 years of age.
* Fibromyalgia for at least the past 3 months, as determined by the referring physician.
* At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

* Specific causes of pain (e.g., cancer, fractures, spinal stenosis, infections)
* History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
* Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Criteria for healthy adults.

Inclusion Criteria:

* Volunteers 18-50 years of age.
* At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

* Chronic and acute pain (ex. Fibromyalgia).
* History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
* Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Primary outcomes:
measure: Arterial spin labeling (ASL) before and after Tai Chi intervention.
timeFrame: 12 weeks
Secondary outcomes:
measure: Resting-state BOLD fMRI before and after Tai Chi intervention.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jian Kong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01797419: Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Ranging Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5806 in Subjects < 24 Months of Age Hospitalized for Respiratory Syncytial Virus (RSV) Related Respiratory Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory
Syncytial
Virus
RSV
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.


Eligibility criteria: Inclusion Criteria:

* \<24 months of age
* Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening

Exclusion Criteria:

* Chronic or congenital heart disease
* Required ventilation or admission to any pediatric Intensive Care Unit
* Inadequate organ function

Primary outcomes:
measure: Safety and tolerability
timeFrame: 10 days from subject randomization to study drug
Secondary outcomes:
measure: Pharmacokinetics effects of GS-5806
timeFrame: 10 days from subject randomization to study drug
Other outcomes:
Locations:
city: Geelong
country: Australia
facility: Geelong Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Center
city: Herston
country: Australia
facility: Queensland Children's Medical Research Unit
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: North Adelaide
country: Australia
facility: Women's and Children's Hospital Adelaide
city: Parkville
country: Australia
facility: Royal Children's Hospital
city: Randwick
country: Australia
facility: Sydney Children's Hospital
city: Subiaco
country: Australia
facility: Princess Margaret Hospital for Children
city: Westmead
country: Australia
facility: Westmead Children's Hospital
Study officials:
affiliation: Queensland Children's Medical Research Unit, Herston, AUS
name: Peter Sly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03279419: Thermal Imaging in Liver Disease.
Official title: Thermal Imaging of the Peripheral Vasculature in Liver Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-70 with acute or chronic liver disease

Brief summary: This is a feasibility study, to assess if thermal imaging and/or near infrared imaging will be useful in identifying changes in the peripheral circulation in patients with different stages of liver disease.

The aim of this study is to use new and advanced thermal imaging techniques to identify changes in the peripheral circulation and hand temperature in patients with liver disease. These changes could be used as a non-invasive marker of the severity and progression of liver disease. Thermal imaging will also be used to assess the changes in the peripheral vasculature with the use of terlipressin, a drug used as treatment for specific complications of liver disease.

Patients with acute or chronic liver disease from any aetiology will be recruited, along with patients without liver disease as healthy controls. Patients with disease or on drugs known to affect the peripheral vasculature will be excluded.

All studies will be performed in a ward setting in the Royal Infirmary of Edinburgh. The subjects will be required for up to three sessions, each lasting 30 minutes. The session will involve static thermal images being taken, and video images of the hands warming up after being cooled for 30 seconds in water at a temperature of 7 degrees Celsius. If the patient is receiving terlipressin therapy, static images will be taken before, during and after terlipressin therapy.


Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic liver disease (any stage)
* diagnosis of acute liver disease (any aetiology)

Exclusion Criteria:

* on drugs known to affect peripheral circulation
* conditions known to affect peripheral circulation e.g. Raynauds

Primary outcomes:
measure: Changes in peripheral vasculature as assessed by thermal imaging
timeFrame: 2 years
Secondary outcomes:
measure: Changes in peripheral vasculature in response to terlipressin therapy.
timeFrame: 2 years
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Univerity of Edinburgh and NHS Lothian
Study officials:
References:
Clinical trial NCT03860519: The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma
Official title: The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma (Propeller Health)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
uncontrolled asthma
asthma medication adherence
Propeller Health
Connected Inhaler System
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a behavioral randomized controlled trial of adults with uncontrolled persistent asthma that tests if the Propeller Health sensor, mobile application, and dashboard can improve adherence to ICS.


Eligibility criteria: Inclusion Criteria:

* Under the care of a staff asthma physician (i.e. pulmonologist or allergist/immunologist) at NorthShore University HealthSystem (NS)
* Have an active NorthShore Connect (patient portal) account
* Persistent uncontrolled asthma in the past 12 months
* Active prescription for daily ICS medication for asthma

Exclusion Criteria:

* candidate refusal
* the presence of other co-morbidities (e.g. severe psychiatric disorder) that could interfere with study participation

Primary outcomes:
measure: Change in Short Acting Bronchodilator Medication use in Group with Propeller Health Platform Digital Technology Turned On vs Group with Propeller Health Platform Digital Technology Turned Off
timeFrame: 3.5 months
Secondary outcomes:
measure: Participant and clinician satisfaction as assessed by brief post-study survey of Propeller Health Platform Digital Technology
timeFrame: 3.5 months
measure: Inhaled Corticosteroid Medication taking Behavior in the Group using Propeller Health Platform Digital Technology Turned On vs Group using Propeller Health Platform Digital Technology Turned Off
timeFrame: 3 months
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Giselle Mosnaim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mosnaim GS, Stempel DA, Gonzalez C, Adams B, BenIsrael-Olive N, Gondalia R, Kaye L, Shalowitz M, Szefler S. Electronic medication monitoring versus self-reported use of inhaled corticosteroids and short-acting beta2-agonists in uncontrolled asthma. J Asthma. 2022 Oct;59(10):2024-2027. doi: 10.1080/02770903.2021.1996600. Epub 2021 Nov 2.
Clinical trial NCT02165319: The Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change
Official title: Comparison of the Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change: Barrel-shaped vs. Taper-shaped Cuff
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation
Pain
Pharyngitis
Hoarseness
Cough
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped cuff

Detailed description: The position of endotracheal tubes depends on the position of the patients. The change of the tube's position is known to influence the pressure of tube's cuff. The shape of the cuff (barrel-shaped versus tapered-shaped) may affect the tube's migration degree because of the difference of the frictional force.

The investigator try to compare the the cuff pressure after supine-to-lateral position change between barrel-shaped cuff and taper-shaped cuff.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for nephrectomy in lateral decubitus position

Exclusion Criteria:

* Pregnancy
* Patients with difficult airway
* Patients with neck motion disorder
* Patients with history of neck surgery
* Patients with history of oral and pharyngeal surgery
* Patients with body mass index \> 35
* Patients without teeth

Primary outcomes:
measure: The cuff pressure after supine-to-lateral position change
timeFrame: At 10 minutes after anesthetic induction
Secondary outcomes:
measure: The distance from the tube to the carina
timeFrame: At 10 minutes after anesthetic induction
measure: Complications related to endotracheal tube
timeFrame: At 0, 2, and 24 hours postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University of Hospital
name: Hee-Pyoung Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HC, Lee YH, Kim E, Oh EA, Jeon YT, Park HP. Comparison of the endotracheal tube cuff pressure between a tapered- versus a cylindrical-shaped cuff after changing from the supine to the lateral flank position. Can J Anaesth. 2015 Oct;62(10):1063-70. doi: 10.1007/s12630-015-0394-z. Epub 2015 Apr 17.