louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02067273: Transcranial Magnetic Stimulation (TMS) for CRPS
Official title: Transcranial Magnetic Stimulation for CRPS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndrome (CRPS)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 20
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 purpose of this pilot study is to test the durability of response to Transcranial Magnetic Stimulation (TMS) for the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS for varying lengths of time in a pilot study to investigate what the clinical impact.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Diagnosis of CRPS (complex regional pain syndrome)
* Average pain level reported on Numerical Rating Scale meets entry criteria
* Ability to perform the experimental task and procedures.

Exclusion Criteria:

* MRI contraindication (metal implants or devices, claustrophobia)
* TMS Contraindication (eg metal implant or devices near the site of stimulation)
* History of epilepsy
* History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
* Neurologic illness that would interfere with brain integrity
* Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
* Currently pregnant or planning to become pregnant.
* On going legal action or disability claim.

Primary outcomes:
measure: Present Pain Intensity
timeFrame: Baseline, post-treatment, one week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
Clinical trial NCT02389673: Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer
Official title: Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Keywords: Intermediate and high grade ductal carcinoma in situ （DCIS）
Lead sponsor: Guangdong Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 222
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Whether the patients with low grade ductal carcinoma in situ breast cancer should accept radiationtherapy is uncertain.Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Detailed description: Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Eligibility criteria: Inclusion Criteria:

* Tumor diameter \< 5 cm
* Low grade ductal carcinoma in situ
* Candidate for breast-conserving surgery
* Must have undergone lumpectomy with negative margins or minimal margin involvement
* Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
* No evidence of metastatic disease
* Informed consent

Exclusion Criteria:

* No informed consent
* Tumor size \> 5 cm
* Intermediate or high grade ductal carcinoma in situ
* Invasive carcinoma
* No indication for a boost

Primary outcomes:
measure: ipsilateral breast tumor recurrence rate after surgery within five years
timeFrame: Within 5 years after surgery
Secondary outcomes:
measure: Disease free survival after surgery within five years
timeFrame: Within 5 years after surgery
measure: Overall survival after surgery within ten years
timeFrame: Within ten years after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Academy of Medical Sciences
state: Guangdong
Study officials:
affiliation: Guangdong Academy of Medical Sciences
name: Liao Ning, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06106373: iotaSOFT Pediatric Study
Official title: iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Loss, Unilateral
Lead sponsor: iotaMotion, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.


Eligibility criteria: Inclusion Criteria:

* Candidate for unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices
* Age 9 months to less than 12 years old at the time of CI surgery
* Willingness to participate in the study and able to comply with the follow-up visit requirements

Exclusion Criteria:

* Prior cochlear implantation in the ear to be implanted
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion
* Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations
* Deafness due to lesions of the acoustic nerve or central auditory pathway
* Diagnosis of auditory neuropathy.
* Active middle-ear infection or tympanic membrane perforation in the presence of active middle-ear disease
* Absence of cochlear development
* Additional medical concerns that would prevent participation in evaluations as determined by the investigator
* Planned or current participation in a clinical study of an investigational device or drug

Primary outcomes:
measure: Safety related to adverse events
timeFrame: 30 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
Study officials:
affiliation: iotaMotion, Inc.
name: Laura Chenier
role: STUDY_DIRECTOR
References:
Clinical trial NCT02260973: The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity
Official title: The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity Outcomes In Cases Undergoing Cataract Surgery: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cataract, Dry Eye Disease
Lead sponsor: Physician Recommended Nutriceuticals
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized, masked, placebo controlled study to assess the effect on visual acuity, if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Presence of nuclear or cortical lens opacities in one/both eyes
* Physician diagnosis of age related cataract
* Good overall physical constitution
* All participants must be follow the same regimen for surgery related medications, both pre and post surgery. (Antibiotic, NSAID and Steroid eye drops)

Exclusion Criteria:

* Subjects requiring Premium IOLs/multifocal implants
* Advanced cataract
* Severe Age-Related Macular Degeneration Presence or history of Glaucoma
* Presence or history of Diabetes Mellitus
* Any Retinal pathology - retinal detachment, retinitis pigmentosa, diabetic retinopathy, etc
* Vision loss due to Central retinal artery occlusion or Central retinal vein occlusion
* Vision loss due to presence of large pituitary tumors or aneurysms
* Vision loss due to optic tract lesions
* Vision loss due to bleeding into aqueous or vitreous chamber
* Vision loss due to drug toxicity: Amiodarone, anti-tuberculosis drugs, hydroxychloroquine, tamoxifen
* Major cardiovascular or cerebral events in the past 12 months
* Allergy to fish oil or safflower oil
* Pregnancy or lactation at any time during the study
* Newly started or increased the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Screening or at any time during the study
* Participation in any other study involving an investigational drug or device within the past 30 days

Primary outcomes:
measure: Visual Acuity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Greenville
country: United States
facility: Southern Eye Associates
state: South Carolina
Study officials:
affiliation: Southern Eye Associates
name: Bradley Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04032873: Distal Radius Buckle Fracture RCT
Official title: Influence of Cost Information on Cast vs. Splint Decision-Making After Pediatric Buckle Fractures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Distal Radius Fracture
Cost
Buckle Fracture
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 129
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the influence of cost information on decision-making for immobilization for treatment of distal radial buckle fractures. Half of the participants will receive cost information from an orthopaedic surgeon prior to making their decision for treatment, while the other half will receive cost information from another member of the study team after they had made their decision treatment.

Detailed description: Research has shown equipoise in treatment outcomes after casting and splinting for pediatric buckle fractures. Despite the similarly favorable treatment outcomes associated with both casting and splinting these fractures, there is wide disparities in cost between the two types of immobilization. However, cost information is not routinely presented to families during the discussion of immobilization types.

The primary objective of this study is to determine if cost information influences family decision-making about immobilization type after pediatric buckle fractures. A secondary objective is to determine if the timing of and person disseminating the cost information changes the influence it has on families' decision-making.

Eligibility criteria: Inclusion Criteria:

* Males or females ages 4 to 14 years with a buckle fracture for which they will be treated with a cast or a splint.
* Parental/guardian permission (informed consent) and, if appropriate, child assent.
* Parent of a child ages 4 to 14 years with a buckle fracture that requires treatment with either a cast or a splint.
* Parental/guardian permission (informed consent).

Exclusion Criteria:

* Non-English speaking subjects.
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Primary outcomes:
measure: Monetary Cost of Immobilization's Influence on Treatment Decisions
timeFrame: 1 to 5 minutes
Secondary outcomes:
measure: Timing/Person Effect on Decision-Making
timeFrame: 1 to 5 minutes
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: John Todd R Lawrence, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02167373: Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform
Official title: Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Health With Medical Comorbidities
Lead sponsor: Cogito Health Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
name: Brigham and Women's Hospital
name: Partners HealthCare
First posted: 2014-06-19
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether the use of a mobile sensing platform in a primary care setting has an effect on provider workflows, patient outcomes, patient engagement, patient self-help behavior, health research, and total cost of care.


Eligibility criteria: Inclusion Criteria:

* Be between 18 and 70 years of age.
* Speak, understand, and read conversational English.
* Be a current patient of South Huntington Clinic recommended for behavioral health care.
* Have a smartphone and cell service plan, including voice and data, that meets the device requirements of the Mobile Sensing Platform.

Exclusion Criteria:

* Planning on permanently leaving Boston during the study period.

Primary outcomes:
measure: Treatment Outcome
timeFrame: Change from baseline to six months later
measure: Quality of Life Outcome
timeFrame: Change from baseline to six months later
Secondary outcomes:
measure: Cost of Care
timeFrame: Measured at six months
measure: Patient Engagement
timeFrame: Measured at six months
measure: Self-Help Behavior
timeFrame: Measured at six months
measure: Clinical Outcome (GAF)
timeFrame: Change from baseline to six months later
Other outcomes:
Locations:
city: Jamaica Plain
country: United States
facility: South Huntington Clinic
state: Massachusetts
Study officials:
References:
Clinical trial NCT04338373: Effectiveness of 0.01% Atropine Sulfate Solution in Controlling of Myopia Progression in Children
Official title: Open Prospective With Historical Control Clinical Study of 0.01 % Atropine Sulfate Effectiveness in Controlling of Myopia Progression in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myopia
Keywords: myopia
low dose atropine
progressive myopia
atropine in non-asian population
Lead sponsor: The V.P. Vyhodcev Eye Hospital
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open prospective clinical trial with historical control
Primary purpose: TREATMENT

Brief summary: Increasing number of myopic children and significant complications of high myopia enhance the necessity of effective control strategy. Instillations of low-dose atropine have been shown to reduce myopia progression in Asian populations but its effect in non-Asian populations is still unclear. This open prospective study with historical control is designed to investigate if 0.01% atropine can reduce myopia progression in Russian children, taking into account a change of difference between manifest and cycloplegic refraction, as well as, myopia progression rate at the time of recruitment.

Detailed description: The study is designed to test the following hypotheses:

* 0.01% atropine one drop nightly is safe and with no significant side effects.
* nightly instillations of 0.01% atropine does not influence tear production.
* 0.01% atropine one drop nightly reduces the progression of childhood myopia in Russian children.
* nightly instillations of 0.01% atropine decreases the manifest refraction and, consequently, difference between manifest and cycloplegic refractions.
* effectiveness of 0.01% atropine depends on the age and myopia progression rate at the time the therapy was started.

Eligibility criteria: Inclusion Criteria:

* myopia progression rate of 0.5D or more per year;
* myopia with astigmatism of 1.0D or less;
* axial length and cycloplegic refraction data obtained 6 months before recruiting or earlier
* signed informed consent.

Exclusion Criteria:

* congenital myopia;
* onset of myopia at 6 years old or earlier;
* allergic reactions to any eye drops in anamnesis;
* concomitant eye disorders, including strabismus.

Primary outcomes:
measure: change in axial length
timeFrame: baseline - 12 months
measure: change in myopic progression rate
timeFrame: baseline - 12 months
Secondary outcomes:
measure: change in difference between manifest and cycloplegic refractions
timeFrame: baseline - 12 months
measure: change in positive relative accommodation
timeFrame: baseline - 12 months
measure: tear production
timeFrame: baseline - 12 months
Other outcomes:
Locations:
city: Omsk
country: Russian Federation
facility: The V.P. Vyhodcev Eye Hospital
Study officials:
References:
Clinical trial NCT04351373: Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
Official title: Microscopic Fluorescence-guided Vestibular Schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vestibular Schwannoma
Keywords: Head and Neck Paraganglioma
Head and Neck Schwannoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to see if there is benefit to using an IV contrast called AK-Fluor® and a microscope filter called YELLOW560 when surgically removing a vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma.


Eligibility criteria: Inclusion Criteria

* Patient with a suspected VS
* Recurrent VS with prior microsurgical resection or radiation therapy
* Clinical indication for microsurgical resection

Exclusion Criteria

* History of allergy to FS
* History of renal failure
* Pregnant women
* Those with inability to give informed consent
* Prisoners and inmates

Primary outcomes:
measure: Surgeon Predicted Use of Fluorescein Sodium in Future Cases
timeFrame: Approximately 3 months postoperatively
measure: Correlation of Fluorescein Sodium With Surgeons' Visual Assessment
timeFrame: Intraoperatively, approximately 1 day
measure: Correlation of Fluorescein Sodium With Electrostimulation
timeFrame: Intraoperatively, approximately 1 day
Secondary outcomes:
measure: Time to Differential Visualization
timeFrame: Intraoperatively, approximately 1 day
measure: Average Dose of Sodium Fluorescein Administration
timeFrame: Intraoperatively, approximately 1 day
measure: Total Resection Rate
timeFrame: Intraoperatively, approximately 1 day
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew L Carlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan SA, Macielak RJ, Tuchscherer AM, Neff BA, Driscoll CLW, Peris-Celda M, Van Gompel JJ, Link MJ, Carlson ML. Fluorescein-Assisted Microsurgical Resection of Vestibular Schwannoma: A Prospective Feasibility Study. Otol Neurotol. 2022 Dec 1;43(10):1240-1244. doi: 10.1097/MAO.0000000000003718. Epub 2022 Oct 14.
Clinical trial NCT06673173: Patient Satisfaction and Oral Health-Related Quality of Life of Quadrilateral Versus Bilateral Linear Bar Designs for Four Implant Implant-Assisted Complete Mandibular Overdenture Regarding Peri-Implant Crestal Bone Loss
Official title: Patient Satisfaction and Oral Health-Related Quality of Life of Quadrilateral Versus Bilateral Linear Bar Designs for Four Implant Implant-Assisted Complete Mandibular Overdenture Regarding Peri-Implant Crestal Bone Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulism
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: For this study, twenty patients were selected, and participants were randomly divided into two groups using random numbers produced in an Excel spreadsheet. Each patient got four implants in the mandibular canine and first molar sites, as well as the bar attachment.

The purpose of this study was to document and report patient satisfaction with mandibular implant overdentures with quadrilateral distribution and linear distribution. The null hypothesis was that patient satisfaction would not be different depending on the distribution type (quadrilateral or linear).

According to the bar design, all patients were classified into two equal groups: quadrilateral bar design (group I) and bilateral linear bar design (group II). Peri-implant marginal bone loss was evaluated immediately (T0) and after 2 years (T2) of overdenture insertion using a digital periapical X-ray.


Eligibility criteria: Inclusion Criteria:

* have Angle's class I maxilla-mandibular relation
* sufficient inter-arch space
* a healthy, firm mucosa,
* enough residual alveolar ridges in the mandibular regions to support implants

Exclusion Criteria:

* neuromuscular disorder,
* excessive smoking,
* alcoholism,
* parafunctional habits
* systemic disorders affecting the bones
* history of head and neck radiation therapy.

Primary outcomes:
measure: marginal bone loss
timeFrame: Peri-implant marginal bone loss was evaluated immediately (T0) and after 2 years (T2) of overdenture insertion using a digital periapical X-ray.
measure: Patient Satisfaction
timeFrame: Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Heba Wageh Abozaed
Study officials:
affiliation: Cairo University
name: Heba Abozaed, phd
role: PRINCIPAL_INVESTIGATOR
References: