louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05288569: irAE Prediction of Anti-PD-1/L1 in Lung Cancer
Official title: Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Checkpoint Inhibitors
Lung Cancer
Keywords: immunology
biomarkers
prediction
multidimensional
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at a national tertiary referral center for lung cancer treatment

Brief summary: the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer

Detailed description: After being informed of the study and potential risk, all patients giving written informed consent will undergo peripheral blood sample collection at baseline (before treatment ), 1month and 3month after treatment initiation, and when immune-related adverse events ever occur. The follow-up period will be 1 year for any occurrence of immune-related adverse events and 2 years follow-up for the prognosis.

Eligibility criteria: Inclusion Criteria:

* 18-80 years of age
* Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques
* Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication)

Exclusion Criteria:

* Other cancer treatment
* Other malignancies

Primary outcomes:
measure: occurrence of immune-related adverse event (irAE)
timeFrame: 12 months since immunotherapy initiation
Secondary outcomes:
measure: Overall Survival
timeFrame: 24 months since immunotherapy initiation
measure: Progression Free Survival.
timeFrame: 24 months since immunotherapy initiation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Huaxia Yang
role: STUDY_CHAIR
References:
citation: Yang H, Yao Z, Zhou X, Zhang W, Zhang X, Zhang F. Immune-related adverse events of checkpoint inhibitors: Insights into immunological dysregulation. Clin Immunol. 2020 Apr;213:108377. doi: 10.1016/j.clim.2020.108377. Epub 2020 Mar 2.
Clinical trial NCT05791669: Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution
Official title: Arrest of Interproximal Caries Lesion in Primary Molars With 38% Silver Diamine Fluoride Solution and 5% Sodium Fluoride Varnish: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Caries Arrested
Keywords: Caries arrest ,interproximal caries, primary molars, SDF
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 45
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest.

Interproximal caries included in this study, according to ICCMS criteria, were at stages- RA - caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3 - caries limited to outer third of dentine RA4 - caries limited to middle third of dentine


Eligibility criteria: Inclusion Criteria:

1. Children aged 5 to 9 years.
2. Presence of at least 2 primary molars with interproximal caries.
3. Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4).

Exclusion Criteria:

1. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6).

3. Children or adolescents that refuse to participate in the study or present negative behaviours.

4. Teeth with premature hypermobility 5. Both physically and mentally disabled children

Primary outcomes:
measure: Caries arrest
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post graduate institute of dental sciences
state: Haryana
Study officials:
References:
Clinical trial NCT02953769: Prevena Incision Management System Wound Care
Official title: Use of Prevena Incision Management System in Wound Morbidity in Complex Ventral Hernia Patients. A Prospective Randomized Control Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ventral Hernia
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: KCI USA, Inc
First posted: 2016-11-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective Ventral hernia repair

Brief summary: Comparison of ventral hernia repair using standard wound care versus Prevena.

Detailed description: Compare the outcomes for patients who have abdominal reconstruction for ventral hernia repair, regarding wound morbidity, post-operative pain and patient comfort to ambulation, with the use of Prevena™ to those patients who have ventral hernia repair to those who have standard wound care.

Eligibility criteria: Inclusion Criteria:

1. Age 18 - 89
2. Open ventral hernia repair with or abdominal wall reconstruction after midline or non-midline defects.
3. Able to provide informed consent

Exclusion Criteria:

1. Immunosuppresses patients
2. Children 0 - 17

Primary outcomes:
measure: Primary Objective for Wound Care Comparison
timeFrame: December 31, 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Celebration
country: United States
facility: Florida Hospital Celebration Health
state: Florida
Study officials:
affiliation: Physician
name: Eduardo Parra Davila, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05856669: The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke
Official title: The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn about the benefits of using a virtual reality gaming system that can be adjusted for a person who has upper arm weakness from stroke. The main question it aims to answer is whether strength and movement in the upper arm be improved by use of the gaming system.

Participants will be asked to complete initial measurements of upper arm function, play a video game for one hour, four times a week for five weeks, and repeat the measurements of upper arm function at the end.


Eligibility criteria: Inclusion Criteria:

* Self-reported diagnosis of stroke
* Greater than 2 years post-stroke
* Access to reliable transportation
* History of weakness/hemiparesis of one upper limb

Exclusion Criteria:

* Significant vision impairment or blindness
* Non-English speaking
* History of seizure or seizure disorder
* Health conditions which would be exacerbated by low-intensity exercise
* Inability to use arms independently for exercise

Primary outcomes:
measure: Change in upper extremity active range of motion
timeFrame: 6 weeks
measure: Change in grip strength
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in aerobic fitness
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Lakeshore Foundation Research Collaborative
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jason Vice, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.
citation: Mekbib DB, Zhao Z, Wang J, Xu B, Zhang L, Cheng R, Fang S, Shao Y, Yang W, Han J, Jiang H, Zhu J, Ye X, Zhang J, Xu D. Proactive Motor Functional Recovery Following Immersive Virtual Reality-Based Limb Mirroring Therapy in Patients with Subacute Stroke. Neurotherapeutics. 2020 Oct;17(4):1919-1930. doi: 10.1007/s13311-020-00882-x.
citation: Modrono C, Navarrete G, Rodriguez-Hernandez AF, Gonzalez-Mora JL. Activation of the human mirror neuron system during the observation of the manipulation of virtual tools in the absence of a visible effector limb. Neurosci Lett. 2013 Oct 25;555:220-4. doi: 10.1016/j.neulet.2013.09.044. Epub 2013 Sep 27.
Clinical trial NCT04664569: National Bacterial Meningitis Study
Official title: National Observatory of Bacterial Meningitis in Children and Newborns
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Meningitis
Children, Only
Pneumococcal Conjugate Vaccine
Meningococcal Vaccines
H. Influenzae Vaccine
Neonatal Infection
Antibiotic Treatment
Case Fatality Rate
Lead sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2020-12-11
Enrollment: 8230
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children 0 day to 18 years with bacterial meningitis or purpura fulminans

Brief summary: Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.


Eligibility criteria: Inclusion Criteria:

* clinical signs of meningitis, associated with positive cerebrospinal fluid (CSF) culture and/or positive CSF antigen testing (Escherichia coli K1, N. meningitidis serogroups B, A, C, Y and W-135, group B streptococci, Hib, or S. pneumoniae), and/or positive CSF polymerase chain reaction (PCR), and/or positive blood culture with CSF pleocytosis (\> 10 cells/µL).
* purpura fulminans

Exclusion Criteria:

-

Primary outcomes:
measure: mortality
timeFrame: before the hospital discharge
Secondary outcomes:
measure: treatment failures
timeFrame: 48 hours after the antibiotic treatment and new lumbar puncture
measure: impact of vaccines
timeFrame: before the hospital discharge
Other outcomes:
Locations:
city: Créteil
country: France
facility: ACTIV
Study officials:
References:
Clinical trial NCT04789369: Fear of Movement, Functionality and Quality of Life in Elite Athletes With an Ankle Instability History
Official title: The Relationship Between Fear of Movement, Functionality and Quality of Life in Elite Athletes With an Ankle Instability History
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Sprains
Keywords: Quality of life
Fear of movement
Functionality
Ankle sprain
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Athletes who are participating in sportive activities regularly

Brief summary: Ankle sprain is frequently experienced by individuals participating in different sports activities. Ankle sprains have been shown to result in a decrease in level of physical activity and persistence of some symptoms for a long time. In this case, it is predicted that ankle sprains may affect the quality of life as well as functionality. Also, ankle sprain history may result in increased fear of movement, which may delay return to sports. This study aimed to examine the relationship between foot and ankle functionality, fear of movement and quality of life of elite athletes with a history of ankle sprain.


Eligibility criteria: Inclusion Criteria:

* No injury to the upper or lower extremities during data collection,
* Being older than 18 years of age,
* Individuals who volunteer to participate.

Exclusion Criteria:

. Having had ankle surgery,

* Has had an injury to his lower extremity in the last 3 months,
* Individuals with a history of neurological / neuropsychiatric disease or arthritis will be excluded from the study.

Primary outcomes:
measure: Foot and Ankle Ability Measure
timeFrame: 1 day
measure: Short Form-12
timeFrame: 1 day
measure: Fear Avoidance Beliefs Questionnaire
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sportomed Fulya Physiotherapy Center
Study officials:
References:
Clinical trial NCT04880369: Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
Official title: DAGMAR: Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Breast Cancer Female
Keywords: Phytoestrogens
Isoflavones
Lignans
Gene expression
Breast cancer
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2021-05-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study planned to include 150 women.
Primary purpose: PREVENTION

Brief summary: The aim is to investigate if soy isoflavones and lignans affect markers of disease progression and gene expression among breast cancer patients receiving neo-adjuvant treatment in a three arm, double-blinded, randomized placebo-controlled trial (RCT) comparing: soy isoflavone supplementation, lignan supplementation, and placebo.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with breast cancer at "Brystkirurgisk Afdeling" at Rigshospitalet and Herlev Hospitals (within the last 30 days).
* Advised (and accepted) to receive neo-adjuvant treatment
* Primary unilateral breast cancer
* Treatment is expected to be curative
* Is expected to be able to attend surgery

Exclusion Criteria:

* Allergic to soy
* Celiac disease
* Inflammatory bowel disease
* Not understanding Danish (patient material and questionnaires are in Danish)
* Prior diagnosis of breast cancer
* Use of dietary supplements containing lignans or isoflavones three months prior to diagnosis

Primary outcomes:
measure: Ki-67
timeFrame: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Secondary outcomes:
measure: Apoptosis marker caspase-3
timeFrame: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
measure: Proliferation Index
timeFrame: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
measure: Patient reported outcomes
timeFrame: Change for completion of first questionnaire (shortly after diagnosis) to second questionnaire (close to time of surgery). Approx. four months (neo-adjuvant setting)
Other outcomes:
measure: Fecal microbiome:
timeFrame: Change measured in first fecal sample (shortly after diagnosis) to second fecal sample (close to time of surgery). Approx. four months (neo-adjuvant setting)
Locations:
Study officials:
References:
Clinical trial NCT03402269: Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study
Official title: Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clavicle Fracture
Adolescent
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 11-17 years old with displaced fractures of the middle third of the clavicle

Brief summary: Clavicle fractures in children are common. Typical treatment includes nonoperative treatment with a sling. Operative treatment is usually limited to open, unstable, fractures with either epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that report the need for additional research for this prevalent fracture. This is an observational study evaluating the functional and patient reported outcomes of displaced clavicle fractures in adolescents. The results from this study will help the orthopedist understand the expected outcomes for a given pediatric patient with a clavicle fracture.


Eligibility criteria: Inclusion Criteria:

* 11-17 years old with fractures of the middle third of the clavicle
* Displaced 100% the width of the clavicle or shortened 1 centimeter
* Operative and non-operative treated clavicles will be eligible for enrollment

Exclusion Criteria:

* Open clavicle fractures
* Ipsilateral shoulder injuries
* Fractures involving the lateral ligaments or the sternoclavicular joint
* Bilateral clavicle fractures
* Pathologic fractures
* Refractures
* Fractures with neurovascular compromise
* Displaced fractures with impending skin compromise
* If there has been more than 21 days between injury and enrollment
* Patients with cognitive disabilities that inhibit the completion of the questionnaires

Primary outcomes:
measure: Range of motion
timeFrame: at 1 year post injury
measure: Radiographic healing
timeFrame: at 1 year post injury
Secondary outcomes:
measure: QuickDash
timeFrame: at 3 months, 6 months and 12 months
measure: PODCI
timeFrame: at 3 months, 6 months and 12 months
Other outcomes:
measure: Strength Measurements
timeFrame: 6 months and 12 months
Locations:
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Christopher C Bray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06624969: Virtual Reality in Reducing Acute Orthopedic Pain
Official title: Virtual Reality in Reducing Acute Orthopedic Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fractures
Keywords: pain control
orthopedic
fracture
hospital
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this research is to show that a virtual reality (VR) service line is feasible and can sustain itself with the ability to take care of patients. Additionally, the investigators aim to learn about the limitations of a service line and provide a pathway for future improvements in building a VR service line that is optimally aligned with the user's needs. Secondary aims are to evaluate the clinical aspects of the patient's outcomes including length of stay, morphine equivalents in pain medicine required during the hospital stay, and user experiences.


Eligibility criteria: Inclusion Criteria:

1. Hospitalized with an orthopedic fracture
2. Able to participate fully in all aspects of the study
3. Able to understand and sign informed consent
4. Individuals with unaided vision or those who can correct their vision using contact lenses

   Exclusion Criteria:
5. Non-English speaking
6. Self-reported history of acute and/or chronic severe motion sickness
7. The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted display.
8. Legally blind or deaf
9. Have had a seizure within the past 1 year
10. Have current (within the past 30 days) clinically significant acute or chronic progressive or unstable/uncontrolled neurologic disorder
11. Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

Primary outcomes:
measure: opioid use
timeFrame: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
Secondary outcomes:
measure: reduction in anxiolytics
timeFrame: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
measure: hospital length of stay
timeFrame: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
measure: reduction in sleep aids prescribed
timeFrame: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
measure: User experiences
timeFrame: obtained once on the day of hospital discharge, up to 5 weeks from study enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Scott Helgeson, MD
role: PRINCIPAL_INVESTIGATOR
References: