louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05379764: VR Embodiment for Stress Evaluation in a Return to Work Simulation
Official title: A Randomized Controlled Single Blind Parallel Study, Evaluating Embodiment in a VR Scenario Designed to Elicit Stress in a Return to Work E-vironment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Virtual Reality
Stress
Burnout
Keywords: Virtual reality
stress
embodiment
Burnout
Lead sponsor: Clinique Saint-Jean, Bruxelles
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
First posted: 2022-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel single blind randomised controlled trial
Primary purpose: OTHER

Brief summary: Comparing the emotional effect of two different versions of one VR experience. The VR experience will simulate a typical return to work situation after an absence due to burnout.

The difference of the VR scenario is the point of view. In the first version, the 'standard' version, the user is looking at the VR experience from a neutral point of view, as if s/he was watching a 2D screen. In the second version, the 'embodiment' version, a VR features is added to have the user feeling incarnated in a digital human. This will enhance the feeling of being present in the virtual world and will enhance the emotional answer. The measured endpoint will be the evoked emotions, in particular stress.


Eligibility criteria: Inclusion Criteria:

* working in the office building where the study will be conducted

Exclusion Criteria:

* neurologic disorder precluding the use of VR goggles (epilepsy, ...),
* facial wounds precluding the use of VR goggles.
* a preliminary test evaluating the stress level will be conducted, DASS -21: stress levels above moderate is an exclusion criteria

Primary outcomes:
measure: measured stress level
timeFrame: this will be evaluated after the intervention and will take 15 min.
Secondary outcomes:
measure: measured Emotional level
timeFrame: 15 min, before (baseline) and after the intervention
measure: measured stress baseline
timeFrame: 15min, before the intervention
measure: embodiment evaluation
timeFrame: 20 min after the intervention
measure: plausibility illusion and place illusion
timeFrame: 20 min after intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03718364: Swiss Atrial Fibrillation Pulmonary Vein Isolation Registry
Official title: Swiss Atrial Fibrillation Pulmonary Vein Isolation Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Catheter-based Ablation of Atrial Fibrillation
Keywords: atrial fibrillation
pulmonary vein isolation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 3000
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: All patients undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation) at the hospital. The projected duration of the study is open-end with no projected date of study end. Approximately 150-200 patients per year will be included.

Brief summary: Registry of patients with atrial fibrillation undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation) to determine long-term success rates of catheter-based ablation of atrial fibrillation (pulmonary vein isolation) and to evaluate factors associated with long-term success of catheter-based ablation of atrial fibrillation (pulmonary vein isolation).


Eligibility criteria: Inclusion Criteria:

* patients undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation)

Exclusion Criteria:

* Patients not able or willing to participate in this study

Primary outcomes:
measure: changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
timeFrame: before catheter-based ablation of atrial fibrillation and 3, 6 and 12 months after catheter-based ablation of atrial fibrillation
Secondary outcomes:
measure: morphologic changes of left cardiac atrium
timeFrame: before catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
measure: changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
timeFrame: 12 months after catheter-based ablation of atrial fibrillation and then at intervals of one year until 2035
Other outcomes:
measure: determination of factors associated with long-term success rates of catheter-based ablation of atrial fibrillation
timeFrame: Blood samples gained during catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
Locations:
city: Basel
country: Switzerland
facility: Cardiology/Electrophysiology, University Hospital Basel
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: Cardiology/Electrophysiology, University Hospital Basel
name: Michael Kuehne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyre PB, Sticherling C, Spies F, Aeschbacher S, Blum S, Voellmin G, Madaffari A, Conen D, Osswald S, Kuhne M, Knecht S. C-reactive protein for prediction of atrial fibrillation recurrence after catheter ablation. BMC Cardiovasc Disord. 2020 Sep 29;20(1):427. doi: 10.1186/s12872-020-01711-x.
Clinical trial NCT00786864: Exercise for Low Back Pain in Children
Official title: School-Based Specific Exercise Programme Reduces the Prevalence and Intensity of Low Back Pain in 12-13 Year Old Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Randomised controlled trial
low back pain
exercise
children
school-based
prevalence
intensity
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2008-11-06
Enrollment: 72
Sex: ALL
Minimum age (years): 12
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to determine the efficacy of an eight-week specific exercise programme in reducing self-reported episodes and intensity of LBP, as well as modifying some of the identified risk factors for LBP, in children.


Eligibility criteria: Inclusion Criteria:

* Children aged 12-13 years
* Complained of LBP in the past three months

Exclusion Criteria:

* Serious spinal pathologies or deformities (e.g. severe scoliosis, spinal tumours)
* Neurological conditions which alter motor tone
* Physical disabilities (e.g. spinal cord injuries) which prevent the child from being able to stand up on their own without an orthotic device or brace, or which prevent the child from taking part in normal physical education (PE) classes
* Any other serious co-morbidities (e.g. cancer, severe lung pathology)
* Provincial sports participants, or children who were currently following a specific training programme with a biokineticist or physiotherapist
* Current orthopaedic procedures or fractures of the spine, pelvis, lower or upper limbs

Primary outcomes:
measure: Low Back Pain Prevalence
timeFrame: 3 months post-intervention
measure: Low Back Pain Intensity
timeFrame: 3 months post-intervention
Secondary outcomes:
measure: Neural Mobility
timeFrame: 3 months post-intervention
measure: Hamstring Flexibility
timeFrame: 3 months post-intervention
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Government primary schools in the Ekurhuleni West and Johannesburg East Districts of Gauteng
state: Gauteng
Study officials:
affiliation: University of Witwatersrand, South Africa
name: Gina L Fanucchi, MSc (Physio)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fanucchi GL, Stewart A, Jordaan R, Becker P. Exercise reduces the intensity and prevalence of low back pain in 12-13 year old children: a randomised trial. Aust J Physiother. 2009;55(2):97-104. doi: 10.1016/s0004-9514(09)70039-x.
Clinical trial NCT05706064: Survey of COVID-19 Infection
Official title: Survey of COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Infections
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 200000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All population from hospital and community

Brief summary: Using online questionnaires, we will obtain data regarding COVID-19 infection and treatment, including incidence rate, hospitalization rate, severity of the infection, medications, mortality rate, etc, in both hospital and communities after the change of disease control policy in China.


Eligibility criteria: Inclusion Criteria:

* N/A

Exclusion Criteria:

* N/A

Primary outcomes:
measure: All-cause mortality
timeFrame: 6 months
Secondary outcomes:
measure: Incidence rate of COVID-19 infection
timeFrame: 6 months
measure: Medication for COVID-19 treatment
timeFrame: 6 months
measure: Hospitalization rate due to COVID-19 infection
timeFrame: 6 months
measure: Severity of COVID-19 infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ling Tao
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, MD, Ph.D.
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Chao Gao, MD, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06658964: Study to Evaluate the Drug-drug Interaction of JMKX003142 in Healthy Subjects
Official title: A Single-center, Non-randomized, Open-label, Self-controlled Phase 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX003142 Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: ADPKD (autosomal Dominant Polycystic Kidney Disease)
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang Hangyu Pharmaceutical Co., Ltd.
First posted: 2024-10-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Fully understand the research content, process, and potential risks of this trial, voluntarily participate in the clinical trial and sign the informed consent,
* Healthy male and female subjects aged ≥18 years and ≤45 years old, Male weight ≥50kg, female weight ≥45kg, body mass index ≥19 kg/m2 and ≤28 kg/m2,
* The health of the subjects was determined by the investigator based on medical history, physical examination, clinical laboratory examination, and 12-lead electrocardiogram, all of which were determined by the investigator to be normal or not clinically significant.

Exclusion Criteria:

* HBV surface antigen, HCV antibody, HIV, or syphilis are positive during screening,
* At the time of screening, the vital signs are within the following ranges: systolic blood pressure \<90 mmHg or \>140 mmHg, diastolic blood pressure \<50 mmHg or \>90 mmHg, pulse \<50 bpm or \>100 bpm and ear temperature 37.5℃or\<35℃,
* More than 5 cigarettes per day during the 3 months prior to screening, Or were unable to quit smoking/containing tobacco products during the trial,
* Have special requirements for diet and cannot comply with the diet provided and corresponding regulations.

Primary outcomes:
measure: Cmax of JMKX003142 in plasma
timeFrame: approximately 5 days after JMKX003142 administered
measure: AUC of JMKX003142 in plasma
timeFrame: approximately 5 days after JMKX003142 administered
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shuguang Hospital Affiliated with Shanghai University of TCM
name: Leilei Zhu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02998164: Improving Outcomes Using Technology for Children Who Are DHH
Official title: Improving Outcomes Using Augmentative and Alternative Communication for Children Who Are Deaf or Hard of Hearing
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hearing Loss
Language Development
Social Behavior
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2016-12-20
Enrollment: 154
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of using augmentative and alternative communication (AAC) technology for enhancing language development in children who are deaf or hard of hearing. Half of the participants will receive AAC technology with their speech and language therapy and half will continue with their usual care models.


Eligibility criteria: Inclusion Criteria:

* documented permanent bilateral hearing loss with severity levels clinically defined in any range (mild to profound);
* identified with a language gap;
* currently receiving speech-language therapy.

Exclusion Criteria:

* primary language other than English
* significant motor impairments
* nonverbal IQ \<60
* children with severe communication disorders (i.e. autism spectrum disorders).

Primary outcomes:
measure: Syntax
timeFrame: Change between baseline and 24 weeks
measure: semantics
timeFrame: Change between baseline and 24 weeks
measure: Discourse
timeFrame: Assessing change between baseline and 24 weeks.
Secondary outcomes:
measure: Language standard scores (receptive and expressive)
timeFrame: Assessing change between baseline and 24 weeks.
measure: Social functioning
timeFrame: Assessing change between baseline and 24 weeks.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital of Colorado
state: Colorado
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jareen Meinzen-Derr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meinzen-Derr J, Sheldon R, Altaye M, Lane L, Mays L, Wiley S. A Technology-Assisted Language Intervention for Children Who Are Deaf or Hard of Hearing: A Randomized Clinical Trial. Pediatrics. 2021 Feb;147(2):e2020025734. doi: 10.1542/peds.2020-025734. Epub 2021 Jan 15.
Clinical trial NCT04868864: The Ontario Multi-Regional Hospital COVID-19 Registry (COREG)- Recovery Trajectory Sub-study
Official title: The Ontario Multi-Regional Hospital COVID-19 Registry (COREG)- Recovery Trajectory Sub-study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pneumonia
Sars-CoV-2 Infection
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2021-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients discharged from hospitals with radiographic and clinical evidence of COVID-19 pneumonia during hospitalization.

Brief summary: Radiological and lung function recovery following Covid-19 infection.

Detailed description: The investigators propose to conduct pulmonary LDCT imaging and physiological lung function assessments, and combine this with detailed multi-regional hospitalization clinical data collection on COVID-19 cases (COREG registry); to inform long-term pulmonary and extra-pulmonary consequences and the recovery trajectory following COVID-19 infection.

Eligibility criteria: Inclusion Criteria:

* Patients discharged from hospital post COVID-19 infection who have radiographic and clinical evidence of COVID-19 pneumonia during hospitalization.
* Patients with evidence of unresolved radiographic changes or persistent hypoxemia.

Exclusion Criteria:

* Failure to comply with study procedures.

Primary outcomes:
measure: Pulmonary changes on LDCT Scan
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
measure: DLCO
timeFrame: Through study completion, an average of 9 months
measure: TLC
timeFrame: Through study completion, an average of 9 months
measure: FEV1
timeFrame: Through study completion, an average of 9 months
measure: FVC
timeFrame: Through study completion, an average of 9 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
affiliation: McMaster University Hospital
name: Mylinh Duong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03958864: A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects
Official title: A PHASE 1, OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY/TOLERABILITY OF CC-90001 IN JAPANESE HEALTHY SUBJECTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Subjects
CC-90001
Japanese
Caucasian
Safety
Pharmacokinetics
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2019-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects.

The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).


Eligibility criteria: Inclusion Criteria:

Subjects must satisfy all of the following criteria to be enrolled in the study:

1. Healthy, adult, male and female subjects.
2. Japanese subjects who were born in Japan and not have lived outside of Japan for more than 10 years, have both parents and grandparents of Japanese origin, and have not significantly modified their diets since leaving Japan.
3. Caucasian subjects who have age and body mass index matched with Japanese subjects.

Exclusion Criteria:

1. Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study or place the subject at unacceptable risk if he/she were to participate in the study.
2. Use of any prescribed systemic or topical medication within 30 days of the first dose administration.
3. Has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.

Primary outcomes:
measure: Pharmacokinetic- AUC0-t
timeFrame: Day 1 and Day 7- 10
measure: Pharmacokinetic- AUC0-∞
timeFrame: Day 1 and Day 7- 10
measure: Pharmacokinetic- CL/F
timeFrame: Day 1 and Day 7- 10
measure: Pharmacokinetic- Vz/F
timeFrame: Day 1 and Day 7- 10
measure: Pharmacokinetic- Cmax
timeFrame: Day 1 and Day 7
measure: Pharmacokinetic- Tmax
timeFrame: Day 1 and Day 7
measure: Pharmacokinetic- t1/2
timeFrame: Day 1 and Day 7- 10
Secondary outcomes:
measure: Adverse Events (AEs)
timeFrame: From enrollment until at least 28 days after completion of study treatment
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Paraxel International
state: California
Study officials:
affiliation: Celgene
name: Ying Ye, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03810664: A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
Official title: A Phase 1, Single-Center, Randomized, Cross-Over, Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-22
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
Primary purpose: OTHER

Brief summary: This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.

Detailed description: The subjects will undergo a screening period (Day -28 to -1), and when eligible for study participation will be randomized to receive one sc injection of one of two somatrogon drug product presentations on Day 0, either the PEN or VIAL presentation. A series of blood draws and study procedures will be carried out over the course of the next 10 days to evaluate the subjects. Following a two week washout period, the subjects will be brought back to the clinic to receive the other somatrogon drug product presentation, and once again followed for the next 14 days to study completion.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers aged 18-55 (inclusive) years
* Body Mass Index (BMI) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg
* Non-smoking (by declaration) for a period of at least six months prior to screening visit

Exclusion Criteria:

-

Primary outcomes:
measure: Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)
timeFrame: 30 days
measure: Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞)
timeFrame: 30 days
measure: Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum
timeFrame: 30 days
Secondary outcomes:
measure: AUCt of IGF-1 and IGFBP-3 levels
timeFrame: 30 days
measure: AUC∞ of IGF-1 and IGFBP-3 levels
timeFrame: 30 days
measure: Cmax of IGF-1 and IGFBP-3 levels
timeFrame: 30 days
measure: Time to maximum concentration (Tmax)
timeFrame: 30 days
measure: Apparent Terminal Rate Constant (λz) and t½
timeFrame: 30 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: QPS Miami Research Associates
state: Florida
Study officials:
affiliation: QPS Miami Research Associates
name: Sandra Pagnusset, MD
role: PRINCIPAL_INVESTIGATOR
References: