louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06247618: Virtual Reality for Pediatric Palliative Care Team
Official title: Virtual Reality as a Tool to Promote Healthcare Providers Wellbeing in Pediatric Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Stress
Keywords: virtual reality
pediatric palliative care
anxiety
burnout
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Is virtual reality a useful and usable tool to improve the psychological well-being of PPC operators? study primary obtv: assessment of occupational psychological well-being (divided into stress, depression, anxiety and risk of burnout) in the population of health professionals working in pediatric palliative care; verify if the virtual reality tool leads to an improvement change at the level of the investigated items (feasibility study). The treatment will have a duration of 4 weeks, with the execution of two sessions per week with the use of a viewer positioned on the head that allows users to navigate and interact in real time with a three-dimensional (3D) environment At time zero (T0), the participants will be administered, shortly before the application of virtual reality, the Mini-Z survey 2.0 questionnaires (the single item burnout question), Depression Anxiety Stress Scales 21 (DASS-21), and a demographic questionnaire (gender, age, profession, shift work, years of work in PPCs). At the end of the compilation, two vision treatments will follow, which will take place three to four days apart.

At time T1 (second week) and time T2 (third week) the DASS-21 will initially be administered followed by two weekly treatments with a visor. At the end (T3) the compilation of both tests (Mini-Z survey 2.0-the single item burnout question and the DASS-21) will be repeated following the last two applications of the viewer.


Eligibility criteria: Inclusion Criteria:

* work within the pediatric hospice of Padua
* Absence of neurological pathologies
* personnel who actively engage in membership/participation during all 4 weeks of the project

Exclusion Criteria:

* Subject do not sign written consent

Primary outcomes:
measure: the psychological well-being of healthcare providers: risk of burnout
timeFrame: Data collection lasted for four weeks
measure: the psychological well-being of healthcare providers: anxiety, depression and stress
timeFrame: Data collection lasted for four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Hospice Pediatrico- Azienda Ospedale Università Padova
state: PD
Study officials:
affiliation: Azienda Ospedale-Università Padova
name: Zanin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05277818: Post-marketing Clinical Follow-up of the Medical Device DIVA®
Official title: Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Disc Herniation
Lead sponsor: SC Medica
Sponsor class: INDUSTRY
First posted: 2022-03-14
Enrollment: 822
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with the DIVA® device operated in the study centers for at least 12 months (with the exception of the first 30 operated by practitioner, to take into account the learning curve), as well as all patients operated on over a period similar before the installation of DIVA® in the establishment, will receive the information note of the study. if the patient agrees to participate to the study, patient's data will be collected on a case report form.

Brief summary: Observational, ambispective, longitudinal, comparative, open, multicentric study.

The main objective is to compare the performance of care in patients operated with and without DIVA®.

Detailed description: The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.

Eligibility criteria: Inclusion Criteria:

* Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant;
* Patient operated for at least 12 months;
* Patient able to understand the information related to the study;
* Patient having indicated his/her non-opposition to the collection of his/her personal data.

Exclusion Criteria:

* History of pathologies, malformations or surgical interventions on the spine;
* Patient belonging to the first 30 operated by the surgeon with the DIVA® implant;
* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
* Patient not benefiting from a social security scheme.

Primary outcomes:
measure: Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
Study officials:
References:
Clinical trial NCT04210518: Balance Training With Stroboscopic Vision
Official title: Influence of Stroboscopic Vision on Balance in Patients With Chronic Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Inversion Sprain
Proprioceptive Disorders
Lead sponsor: University of Jaén
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2019-12-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group.
Primary purpose: TREATMENT

Brief summary: Balance training with stroboscopic vision in patients with chronic ankle instability.

Detailed description: This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group who received no intervention.

Eligibility criteria: Inclusion Criteria:

* a previous episode of ankle sprain in at least 6 months before the beginning of the study
* a score of 25 or less in the Cumberland Ankle Instability Tool
* no history of others musculoskeletal injuries in the lower limbs

Exclusion Criteria:

* an acute ankle sprain within the last six weeks
* Recent lower limb surgery

Primary outcomes:
measure: Ankle range of motion
timeFrame: From baseline to six weeks.
measure: Dynamic balance
timeFrame: From baseline to six weeks.
Secondary outcomes:
measure: Self-reported instability and function
timeFrame: From baseline to six weeks.
Other outcomes:
Locations:
city: Jaen
country: Spain
facility: University of Jaen
Study officials:
References:
Clinical trial NCT02062918: Abdominal Belt Use to Treat Low Back Pain
Official title: Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Low Back Pain
Keywords: Abdominal belt
Chronic low back pain
Pain
Functional capacity
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic mechanical-postural low back pain.

Methods: A randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion. The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient satisfaction (Likert scale); and number of anti-inflammatory pills ingested. Intention-to-treat analysis was also used.

Hypothesis - abdominal belt will improve pain in chronic low back pain patients


Eligibility criteria: Inclusion Criteria:

* patients from both genders,
* between 18 and 65 years of age,
* who sought medical care for a complaint of lumbar pain,
* diagnosed with Chronic low back pain, with VAS for pain between 4 and 8 cm (0-10),
* who agreed to participate in the study and signed terms of informed consent.

Exclusion Criteria:

* diagnosis or under diagnostic investigation of low back pain from secondary causes (spondyloarthopathy, infection, neoplasm, complete sciatica),
* fibromyalgia,
* previous spinal surgery,
* litigation (patients on leave from work or in work leave processes due to low back pain);
* having changed physical activity in previous three months;
* body mass index (BMI) higher than 30;
* acupuncture treatment or physiotherapy in the previous three months

Primary outcomes:
measure: Change in pain using VAS
timeFrame: Baseline, after 1,3, and 6 months
Secondary outcomes:
measure: Change in functional capacity (Roland-Morris questionnaire)
timeFrame: Baseline, after 1,3 and 6 months
measure: Change in hours of abdominal belt use
timeFrame: Baseline, after 1,3 and 6 months
measure: Change in patient satisfaction with treatment using VAS
timeFrame: Baseline, after 1,3 and 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP
Study officials:
References:
Clinical trial NCT03840018: Effectiveness of a Postal Intervention to Improve the Use of PPI
Official title: Randomized Trial to Assess the Effectiveness of a Postal Intervention for Reducing the Chronic Use of Highe Doses of Proton Pump Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Overdose
Lead sponsor: Osakidetza
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 401
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: It was a randomised intervention study, with before-and-after outcome measures and a control group, in patients who had an active long-term prescription for PPIs at high doses for at least 6 months.

Detailed description: The intervention consisted of sending patients an informative letter by post, in which their doctor invited them to seek an appointment for a medication review. Control group patients did not receive such a letter, and they were treated as usual (their doctors received a list of identifiers of patients on high doses).

The main outcome variable was the number of active prescriptions of each PPI dose (high dose/standard dose/treatment cessation) at 6 months after the intervention.

Eligibility criteria: Inclusion Criteria:

* Patients under the care of our organisation who in May 2017 had an active long-term prescription for PPIs at high doses for at least 6 months.

Exclusion Criteria:

* Patients whose GPs declined to participate

Primary outcomes:
measure: Active prescriptions of each proton pump inhibitors dose after the intervention
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hondarribia
country: Spain
facility: Bidasoa Integrated Health Organization
state: Gipuzkoa
Study officials:
affiliation: Osakidetza
name: Elena Valverde
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03981718: Adipose-Induced Regeneration of Breast Skin to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients
Official title: Adipose-Induced Regeneration of Breast Skin (AIR Breast) to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients: A Randomized, Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers are trying to identify the therapeutic effect of injection into the subcutaneous tissue to treat radiation-induced skin injury of post mastectomy in patients with breast cancer.


Eligibility criteria: Inclusion Criteria:

* Females above 18 years old
* Diagnosis with breast cancer, who will be treated by mastectomy and undergo radiotherapy, and will receive breast reconstruction
* Able and willing to sign consent to participate

Exclusion Criteria:

* Breast cancer patients that do not accept to participate
* Patients with previous breast reconstruction surgery

Primary outcomes:
measure: Increase in skin quality
timeFrame: 18 months
measure: Physical Well-Being Using the BREAST-Q Reconstruction Module
timeFrame: 12 months, 18 months
measure: Effects of skin disease on quality of life
timeFrame: 12 months, 18 months
measure: Skin Toxicity Costs
timeFrame: 12 months, 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Antonio Forte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01991613: Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
Official title: Early Liquid Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Growth in Premature Infants
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 43
Sex: ALL
Minimum age (years): 26
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.


Eligibility criteria: Inclusion Criteria:

* inborn at Mount Sinai Medical Center
* gestational age between 26 0/7 weeks and 32 6/7 weeks gestation
* plan by family for their infant to receive human milk feeds

Exclusion Criteria:

* outborn infants
* gestational age \< 26 0/7 weeks or \> 33 0/7 weeks
* major congenital anomalies including cardiac disease, inborn errors of metabolism etc.
* sepsis and/or other serious clinical complication precluding initiation of enteral feeds
* plan by family for their infant to receive primarily preterm infant formula.

Primary outcomes:
measure: Growth velocity
timeFrame: up to 28 days
Secondary outcomes:
measure: weight
timeFrame: average 11 weeks
measure: Length
timeFrame: average 11 weeks
measure: head circumference
timeFrame: average 11 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrea Weintraub, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00967213: Combination of Ranibizumab and Verteporfin Therapy in Neovascular Age-related Macular Degeneration
Official title: Changes in Preferential Hyperacuity Perimeter (PHP) and Fundus Autofluorescence (FAF) in Patients With Neovascular Age-related Macular Degeneration Receiving Combination of Ranibizumab and Verteporfin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate changes in preferential hyperacuity perimeter (PHP) and fundus autofluorescence (FAF) in patients with neovascular age-related macular degeneration receiving combination of ranibizumab (LucentisTM) and verteporfin (Visudyne®) therapy


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Age ≥ 50 years old
* Patients with primary active subfoveal CNV secondary to AMD
* Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/40 to 20/400 using ETDRS chart
* Characteristics of AMD lesion

  * predominantly or minimally classic, or occult
  * absence of prior subfoveal treatment for macular disease
  * total lesion size ≤ 9 optic disc areas, with CNV component ≥ 50% of the lesion (unless a serous pigment epithelial detachment was present, in which case \< 50% CNV was acceptable)
  * active choroidal neovascularization leakage
  * submacular blood \< 50% and subretinal fibrosis \< 25% of the total lesion

Exclusion Criteria:

* additional eye disease that could compromise VA
* CNV unrelated to AMD
* ocular inflammation
* vitreous hemorrhage
* retinal hemorrhage (other than AMD related submacular blood) \> 1 disc areas
* intraocular surgery ≤ 1 month before day 0
* uncontrolled glaucoma
* prior treatments with verteporfin PDT
* laser photocoagulation or other intervention for AMD
* previous treatment with external-beam radiation therapy or transpupillary thermotherapy
* history of vitrectomy

Primary outcomes:
measure: The change in ETDRS visual acuity letter scores from baseline.
timeFrame: every 4 weeks (up to 52 weeks)
Secondary outcomes:
measure: Effect on CNV and RPE using preferential hyperacuity perimeter (PHP) and fundus autofluorescence (FAF). Retinal thickness using optical coherence tomography (OCT). Recurrence of fluorescein leakage. The need for additional PDT treatment
timeFrame: every 4 weeks (up to 52 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dept. of Ophthalmology, KyungHee Medical Center, #1 Hoegi, Dongdaemun-gu
Study officials:
affiliation: Dept. of ophthalmology, KyungHee Medical Center
name: Hyung-Woo Kwak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01576913: Music Pacing in Pediatric Exercise Testing
Official title: Music Pacing in Pediatric Exercise Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Testing With Music Pacing
Keywords: exercise testing
music
VO2 max
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-04-13
Enrollment: 20
Sex: MALE
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Study hypothesis: Music pacing improves the quality of exercise testing in children.

Children tend to cycle in a non-constant pace during exercise testing, which might make the test less reliable.

20 boys will perform two exercise tests on a cycle ergometer. One test will be done with constant tempoed music, and the other without. Different parameters will be checked including pedaling cadence, aerobic fitness, level of work load obtained.


Eligibility criteria: Inclusion Criteria:

* male sex
* currently and generally healthy

Exclusion Criteria:

* presence of chronic disease/ medication use
* BMI above 85%
* trained/competitive cyclists

Primary outcomes:
measure: peak VO2
timeFrame: end of the exercise test, approx.10 minutes
Secondary outcomes:
measure: peak power
timeFrame: exercise test duration, approx.10 minutes
measure: anaerobic threshold
timeFrame: exercise test duration, approx.10 minutes
measure: rating of perceived exertion
timeFrame: exercise test duration, approx.10 minutes
measure: mechanical efficiency
timeFrame: exercise test duration, approx.10 minutes
measure: cadence
timeFrame: exercise test duration, approx.10 minutes
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba_Medical_Center
Study officials:
affiliation: Sheba Medical Center
name: Gal Dubnov-Raz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01852513: Allergic Rhinitis Changes the Sinus Microbiome
Official title: Allergic Rhinitis Changes the Sinus Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that treatment with QNASL will reduce nasal mucosal inflammation induced by the allergy season and prevent the changes in the microbiome caused by the allergy season.


Eligibility criteria: Inclusion Criteria:

1. Males and females between 18 and 55 years of age.
2. Two year history of seasonal allergic rhinitis.
3. Positive skin test to grass and/or tree antigen.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Subjects treated with systemic steroids during the previous 30 days.
4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
5. Subjects treated with oral antihistamine/decongestants during the previous seven days.
6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
7. Subjects treated with immunotherapy and are escalating their dose.
8. Subjects on chronic anti-asthma medications.
9. Subjects with polyps in the nose or a significantly displaced septum.
10. Upper respiratory infection within 14 days prior to study start.

Primary outcomes:
measure: Total Nasal Symptom Score (TNSS)
timeFrame: Two weeks following initiation of treatment
measure: Change in RQLQ Score From Baseline to Two Weeks
timeFrame: Two weeks following initiation of treatment
measure: Change in Percent Eosinophils From Baseline to Two Weeks
timeFrame: Two weeks following initiation of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jayant Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References: