louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05657288: SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter During Hypoxia
Official title: SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
Pulse Oximetry
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional prospective study
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the project is to experimentally compare SpO2 measured on a wrist by commercial Smartwach and on a finger measured by a medical-grade pulse oximeter in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).

Detailed description: The newest models of smartwatches measure peripheral blood oxygen saturation (SpO2) and the technology is rapidly improving. The results of individual studies on the accuracy of SpO2 measurement using smartwatches from different brands are still inconclusive. The study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. The agreement of the measurements of both devices will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure, blood oxygen saturation and medical history

Exclusion Criteria:

* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* injury to the upper limbs or hands that could affect the peripheral perfusion
* diabetes
* hypotension or hypertension

Primary outcomes:
measure: Is there any difference in measured SpO2 between finger and wrist during induced hypoxia?
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Czech Technical University in Prague
Study officials:
affiliation: Czech Technical University
name: Simon Walzel, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rafl J, Bachman TE, Rafl-Huttova V, Walzel S, Rozanek M. Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study. Digit Health. 2022 Oct 11;8:20552076221132127. doi: 10.1177/20552076221132127. eCollection 2022 Jan-Dec.
Clinical trial NCT05330988: Post-stroke Fatigue, Inflammation, tDCS
Official title: Effects of tDCS on Post-stroke Fatigue and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Fatigue
Chronic Stroke
Stroke Sequelae
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Center of Neuromodulation for Rehabilitation
First posted: 2022-04-15
Enrollment: 12
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fatigue is a common condition after an individual has a stroke. While the negative impacts of post-stroke fatigue are well known, the knowledge of the causes of post-stroke fatigue and effective treatments for post-stroke fatigue are lacking. This small study will investigate the possible benefits of transcranial direct current stimulation (tDCS), which uses small electrical currents supplied by a 9-volt battery, on post-stroke fatigue and investigate tDCS' possible anti-inflammatory effects.


Eligibility criteria: Inclusion Criteria:

* Men and women of any race or ethnicity
* 35-80 years of age
* 6+ months post-stroke
* Have clinically present fatigue for 6 months
* Able to walk 10m unassisted

Exclusion Criteria:

* Absolute contraindications to MRI, TMS (transcranial magnetic stimulation), or tDCS (e.g., implanted metal devices, history of seizure, and surgical clips or staples)
* Inability to understand and provide written informed consent
* Multiple strokes on opposite hemispheres
* Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, and dementia)
* Severe hypertension
* Cerebellar or brainstem strokes/lesions
* Concurrent depression and/or anxiety disorders

Primary outcomes:
measure: Change in Fatigue Severity Scale (FSS) Score
timeFrame: Baseline, post-intervention (2-weeks)
Secondary outcomes:
measure: Change in Fatigue Assessment Scale (FAS)
timeFrame: Baseline, post-intervention (2-weeks)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: John H Kindred, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00689988: Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome
Official title: Augmentative and Alternative Communication and Lexical Gain in Children With Down Syndrome: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Down syndrome
communication AIDS for disabled
language development disorders
vocabulary
gestures
language tests
child
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children with Down syndrome (DS) have language development particularities that have negative effects in the communication capacity. By this way, Augmentative and Alternative Communication (AAC) is indicated to this population. The aim of this study was to verify the AAC impact in the lexical gain of children with DS.

Detailed description: Five children with DS, with the same cognitive level, participated in this study. Longitudinal follow-up of twelve months of speech-language therapy with AAC use was undertaken. A lexical evaluation was done at the beginning and the end of this follow-up. Correct responses in the lexical evaluation were increased, but not necessarily in the spoken modality. The comparisons showed significant results in use of substitutions processes, and to no-answers.

Eligibility criteria: Inclusion Criteria:

* genetic diagnosis of Down syndrome
* be at the preoperational period
* good health conditions
* expressive language impairment (communication by vocal and gestures, predominantly)

Exclusion Criteria:

* presence of major malformations
* presence of another genetic syndrome
* severe neonatal asphyxia, hearing impairment or visual

Primary outcomes:
measure: Performance on a initial and final lexical assessments, after 12 months of speech-language therapy
timeFrame: 12 months
Secondary outcomes:
measure: Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Sandra CF Pires, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Suelly CO Limongi, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03033888: Community-Based Cervical Cancer Prevention and Education Among Women Living With HIV
Official title: Community-Based Cervical Cancer Prevention and Education Among Women Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2017-01-27
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The long-term goal is to build a sustainable, community-based outreach program to promote cervical cancer screening among women living with HIV (WLH), thereby reducing related morbidity and mortality. The strategy for achieving this goal is to develop an intervention incorporating health literacy approaches and principles of community-based participatory research. Health literacy is a relatively new concept that has been applied mainly toward identifying high-risk individuals rather than toward changing health behaviors and outcomes. The proposed intervention is the first to integrate health literacy into educating WLH to promote cervical cancer screening. Community Health Workers (CHW) support has also rarely been incorporated into cancer screening interventions targeting WLH, making the proposed intervention a uniquely comprehensive approach. Building on recent successful testing by the investigators of a health literacy-focused intervention to promote cervical cancer screening in recent immigrant women, the investigators will test whether health literacy-focused interventions delivered by trained CHWs will be effective in promoting health literacy and increasing Pap test rates in a new population, WLH. The investigators hypothesize that, compared to WLH in the control group, WLH who receive the health literacy-focused CHW intervention will demonstrate: (1) higher rates of Pap test, (2) greater levels of health literacy, (3) higher levels of cervical cancer knowledge, and (4) higher self-efficacy.


Eligibility criteria: Inclusion Criteria:

* HIV infection Able to read and write English 12+ months since Pap test Willing to provide written consent to allow the team to audit medical records for Pap test use

Exclusion Criteria:

* Had undergone a hysterectomy Pregnant

Primary outcomes:
measure: Completion of Pap test (medical records)
timeFrame: 6 months
Secondary outcomes:
measure: Change scores for health literacy
timeFrame: Baseline and 6 months
measure: Change scores for cervical cancer knowledge
timeFrame: Baseline and 6 months
measure: Change scores for self-efficacy
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins University School of Nursing
name: Hae-Ra Han, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06781788: School-based Intervention to Address Climate Change Emotions
Official title: I Want to Talk About Climate Change, but I Wish I Didn't Have To… a Descriptive Qualitative Study of an Intervention Combining Creative Arts and Philosophical Inquiry to Help Elementary School Students Cope with Climate Change Emotions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eco-anxiety
Keywords: Eco-anxiety in children
Creative arts intervention
Philosophical inquiry intervention
School-based intervention
Lead sponsor: Université du Québec a Montréal
Sponsor class: OTHER
Collaborators: name: Bishop's University
First posted: 2025-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The ORBIT model for intervention development is a framework developed by Czajkowski and colleagues (2015) in collaboration with the National Institute for Health. The model is a systematic approach that helps guide researchers through the various stages of intervention development, evaluation and implementation. The model emphasizes the iterative and dynamic nature of intervention development and evaluation. Phase 1b aims to refine the intervention to optimize it while retaining the components essential to its power to change, which corresponds to the first part of this framework. The data obtained in the previous phase are therefore taken into account to maximize the intervention's effectiveness. Among other things, qualitative methods to assess the acceptability of the intervention in the target population can be used.
Primary purpose: PREVENTION

Brief summary: The goal of this study was to qualitatively document the social validity of an intervention combining creative arts and philosophy inquiry and to examine its acceptability, the perceived goals, and perceived benefits for children's mental health and ability to cope with climate change from the perspective of one elemetary-school class students and their teacher.

The guiding research question was: How do children and their teacher perceive the acceptability, the goals and the benefits of the intervention? The participants were asked to participate in a seven-week creative arts and philosophical inquiry intervention. Once a week, a research assistant led a workshop using creative arts and group philosophical inquiry to discuss the topic of climate change and the emotions that can arise. Students participated in a brief individual interview after the intervention. The teacher also participated in an individual online interview.


Eligibility criteria: Inclusion Criteria:

* Elementary school students between the ages of 8 and 12 years old who's teacher accepted to participate in the study
* Elementary school teacher

Primary outcomes:
measure: Social validity of the intervention
timeFrame: Immediately after the end of the intervention (at week 7)
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Bishop's University
state: Quebec
Study officials:
References:
Clinical trial NCT00862888: Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction
Official title: A 2-Cohort, Multi-Centre, Randomised, Double Blind, Placebo Controlled 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00446687 On Erectile Function In Men Suffering From Erectile Dysfunction, Using 100 Mg Sildenafil As A Positive Control.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erectile Dysfunction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug.


Eligibility criteria: Inclusion Criteria:

* Males aged 18-65 years who has given written informed consent to participate in the study and who suffers moderate to severe erectile dysfunction who has a current or recent successful response to treatment with phosphodiesterase type 5 inhibitors

Exclusion Criteria:

* Males with a history of significant cardiac disease; unstable angina or recent myocardial infarction.
* Males suffering from treated or untreated hypo- or hypertension
* Males currently receiving vasoactive medication
* Males taking medications contraindicated, or cautioned with sildenafil or MC4 agonists

Primary outcomes:
measure: Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device)
timeFrame: Day of dosing
measure: Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire
timeFrame: Day of dosing
measure: Diary of sexual activities
timeFrame: From day of dosing to 7 days post-dose
Secondary outcomes:
measure: PK assessment of PF-00446687 ad sildenafil
timeFrame: Day of dosing
measure: Safety and toleration
timeFrame: Day of dosing to follow-up
measure: Assess variability of response and repeatability of design between 2 similar doses
timeFrame: Comparison of response to be assessed until 7 days post-dose
measure: Assess agouti related protein levels in this population
timeFrame: Day of dosing
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Belfast
country: United Kingdom
facility: Pfizer Investigational Site
state: Northern Ireland
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
state: West Yorkshire
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02964988: uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
Official title: uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer Metastatic
Bone Metastases
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in patients with metastatic castration-resistant prostate cancer (mCRPC)

Detailed description: 68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/CT will be applied in patients with mCRPC during treatment with Radium-223. PET/CT will be performed before initiation of Radium therapy and after two treatment cycles. The initial semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in metastases as well as the change in these parameters after therapy will be correlated with overall survival and progression free survival.

Eligibility criteria: Inclusion Criteria:

* Metastatic castration resistant prostate cancer
* Approved to receive Radium-223 therapy
* Written and oral consent

Exclusion Criteria:

* Lack of communication skills
* Other known malignant disease
* Known allergy towards IMP
* Severe claustrophobia
* If a participant exhibits allergic reaction i the IMP, the participant will be excluded from further participation in the study

Primary outcomes:
measure: uPAR PET/CT imaging
timeFrame: 1 hour post injection
measure: Change in uPAR PET/CT after two cycles of Radium-223
timeFrame: 8 weeks
Secondary outcomes:
measure: uPAR PET/CT as prognostic factor for overall survival
timeFrame: 12 months
measure: uPAR PET/CT as prognostic factor for progression free survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
name: Marie Fosboel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03046888: ROBOTIC PYELOLITHIOTOMY VERSUS PERCUTANEOUS NEPHROLITHOTOMY (PCNL).
Official title: ROBOTIC PYELOLITHIOTOMY VERSUS PERCUTANEOUS NEPHROLITHOTOMY (PCNL).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stone
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Group B will be scheduled to receive RP.
Primary purpose: TREATMENT

Brief summary: Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Group B will be scheduled to receive Robot assisted pyelolethotomy.


Eligibility criteria: Inclusion Criteria:

1. Age above 18 years.
2. Renal stones ≥2 cm.
3. Patients are candidate to PCNL.
4. Patient with ECOG performance score of 2 and less.
5. Able to give informed consent
6. Able to discharges home at the same day.

Exclusion Criteria:

1. Renal stones \< 2cm and can managed by another technique.
2. Known with psychological disease.

Primary outcomes:
measure: Postoperative hospital stay
timeFrame: 30 days
Secondary outcomes:
measure: Stones free rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
References: