cyrilzakka/clinical-trials huggingface dataset:
Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients With Brain Tumors

This trial studies how well spectroscopic magnetic resonance imaging (MRI) guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors. The non-invasive imaging, such as spectroscopic MRI may help to map the differences in tumor metabolism compared to healthy tissue without injection of any contrast agent.

PRIMARY OBJECTIVES:

I. To obtain spectroscopic (s)MRI data from pediatric high grade glioma (HGG) patients before receiving standard of care radiation therapy (RT) and correlate baseline Cho/NAA ratios to recurrence patterns. (Cohort 1, observational) II. To assess the feasibility and safety of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery. (Cohort 2, intervention)

SECONDARY OBJECTIVES:

I. To evaluate how Cho/NAA defined radiation target volumes compare to standard of care radiation target volumes in size and resulting radiation delivery to adjacent normal tissue, by creating mock comparison RT plans for each patient.

II. To compare voxel-to-voxel changes in pre-treatment and post-treatment sMRI and evaluate as potential early predictor of tumor response/recurrence.

III. To evaluate sMRI as a tool in identifying pseudoprogression vs. true progression and correlate post-treatment sMRI metabolite ratios with histopathology if collected.

IV. To report patterns of failure in relationship to the RT field (local, marginal, or distant), progression-free survival (PFS) and overall survival (OS) among all patients.

V. To report patient reported outcomes of health related quality of life (QOL) during and after proton therapy for pediatric HGG.

VI. To build a longitudinal tracking database including clinical data, imaging, and genomic molecular profiling for pediatric HGG treatment.

OUTLINE:

Patients undergo sMRI prior to radiation therapy, at 1, 4, and 7 months after RT, and at the time of suspected recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed high-grade glioma (World Health Organization \[WHO\] grade 3-4). Patients with a radiographically diagnosed high-grade glioma may enroll prior to pathologic confirmation, but would be removed from study if pathology did not confirm the diagnosis of high-grade glioma.
* Primary tumor located within the supratentorial brain.
* Recommended to receive definitive radiation therapy.
* Able to receive MRI scans.
* Both males and females, and members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

* Patients with pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear implants, non-titanium metal in ocular structures, or other incompatible implants which makes MRI safety an issue are excluded.
* Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately tolerate MRI scan are excluded.
* Pathology demonstrated low-grade glioma or other benign or non-invasive brain tumor.
Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma

The main objective of this study was to determine the efficacy of different doses of propranolol in the treatment of ulcerattion infantile hemangioma (IH).

Infantile hemangioma (IH) is the most common benign tumor in infants, with an estimated prevalence of 4%-5%. Although most IH resolves over time without serious sequelae, a significant proportion can lead to serious complications such as ulcers. Propranolol is considered to be an effective treatment modality for ulceration IH, and there are retrospective studies suggesting that starting treatment at a low dose is safe and effective. However, due to the lack of prospective study, the effectiveness of different doses of propranolol for initiating treatment of ulceration IH is unknown. Therefore, a prospective study of ulceration IHs in Chinese children was conducted to clarify its efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. all patients with ulcer IH;
2. children with ulcer IH treated with propranolol.

Exclusion Criteria:

1) children with ulcer IH who received other therapeutic interventions were excluded; 2) Children whose families refused to participate in the study; 3) patients with contraindications to oral propranolol, such as allergy to propranolol, severe bradycardia and bronchial asthma; 4) children lost to follow-up during oral propranolol treatment; 5) children unable to oral propranolol or continue to oral propranolol due to other reasons.

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Magseed Magnetic Marker Localization

The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.

This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion.

Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery.

The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion.

After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a breast lesion requiring image-guided localization prior to excision.
* Subjects aged 18 years or more at the time of consent.

Exclusion Criteria:

* The subject is pregnant or lactating.
* Subject has pacemaker or other implantable device in the chest wall.
* Subject has current active infection at the implantation site in the breast (per investigatordiscretion)
Metabolome and Microbiomic in Fecal Samples

The purpose of this study is to evaluate the effects of storage and handling on fecal samples collected for metabolomic, proteomic and microbiomic and analysis.

Background

Human fecal collection for clinical or research studies usually occurs at the residence of the subject, an environment not equipped with measures to accommodate proper preparation and storage of samples for microbiome and metabolome analysis.

Aims

To evaluate the effects of storage and handling on fecal samples collected for metabolomic, proteomic and microbiomic and analysis.

Methods

Fecal samples will be collected within several minutes of voiding from healthy infants at the time of diaper change at day-care center.

Samples will be divided into 7 tubes, and subjected to different storage temperatures, before preforming microbial analysis by DNA sequencing, and metabolome analysis by H1NMR spectroscoty.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* age 12-20 months
Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease

The PM-Heart algorithm (PMHeartIHD) is an in-house developed software that predict the survival prognosis for the individual patient hospitalized with ischemic heart disease (IHD) after a coronary arteriography has been performed. The software is intended to be used as a clinical decision support system i.e. the calculated survival prognosis is expected to enhance the quality of the treating physician's therapeutic considerations concerning (minor) adjustments to the patients treatment and follow-up - all within the framework of the current medical guidelines. Thus, the algorithm does not "show the physician specifically what to do", but rather ensures a better knowledgebase for the overall interpretation and choice of management of the patient.

To investigate the clinical usefulness of the developed clinical decision support system - the PMHeartIHD algorithm - we wish to investigate whether the clinical use of the algorithm will;

* Improve patient prognosis and,
* Minimize the risk of re-hospitalization,

compared to patients who are treated without the attending/treating physician knowing the algorithm's prognosis?

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients in one of the involved departments of cardiology (see below) with;
* Ischemic heart disease; the clinical presentation may be stable, worsening/unstable angina, non-ST-elevation myocardial infarction or ST-elevation myocardial infarction, and with - Significant coronary artery lesions or diffuse coronary artery disease on invasive coronary angiography during the admission

Exclusion Criteria:

* \<18 years of age
* Living outside Denmark
Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical App in Comparison to a Standardized Method

This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Able to correctly distinguish the body laterality (left and right)
* Able to recognize alphabet letters and read French
* Affiliated to or beneficiary of the French health care system
* Signed/written informed consent
* Subject presenting a level of visual acuity of one of his eyes that fits to one of the pre-set cohort (visual acuity between +1.0 and +0.7 logMAR, between +0.6 and +0.3 logMAR or between +0.2 and 0.0 logMAR); the two eyes can be included in two different cohorts.

Exclusion Criteria:

* Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
* Pregnant and breastfeeding women.
* Subject not considered by the investigator or designee to correctly use OdySight modules after the training session
Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Mandibular Impacted Wisdom Surgery

In this study, bilateral It is aimed to compare the efficacy of tissue adhesive (Periacryl 90) and silk suture in mandibular impacted wisdom tooth surgery.

In the study carried out on a total of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilateral bilateral teeth of the patients was randomly selected and tissue adhesive (Periacryl 90) was applied for wound closure as the experimental group, while the other tooth was determined as the control group and the wound was closed with silk suture. The selected party was determined by the closed envelope method. After the first impacted tooth was extracted, it was waited until the wound healed and the symptoms disappeared completely, then the other tooth was extracted. In both tooth extractions, wound healing, edema and trismus were evaluated on the 3rd and 7th days. Wound healing was evaluated as good, acceptable and bad. VAS (Visual Analog Scale) was used for pain assessment and assessment was made at 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged 18-35 years who accepted the study conditions and had bilateral, bone or mucosal retention, and completely impacted wisdom teeth in the similar position with an indication for extraction due to prophylactic or orthodontic treatment in the lower jaw were included in the study.

Exclusion Criteria:

* Individuals with any systemic disease
* Individuals with a history of allergy to the drugs to be used in the study
* Pregnant and breastfeeding individuals
* Individuals with pain, swelling or trismus in the last 10 days
* Individuals with different positions on the right and left sides
* Individuals who did not sign the voluntary consent form
* Individuals with pathology in the impacted tooth area
* Individuals with limited mouth opening
Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization

The aim of this study is to assess whether the ETMI method can be implemented among primary care practitioners in the central district of Maccabi Health Services and examine whether it provides a medical and economic advantage.

An implementation study- a prospective cohort study with pre- and post-intervention by retrieving economic and therapeutic outcome data from MHS databases. The intervention group will be the Central District of MHS, among 220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment. We will investigate the relationship between the care received and outcomes in terms of healthcare utilization, costs, and patient-relevant outcomes.

Eligibility Criteria:
Inclusion Criteria:

* primary care practitioners and their patients, who suffer from back pain and receive treatment.
* patients who suffer from back pain and receive treatment with or without leg radiation

Exclusion Criteria:

* no
The Injection-Related InfectionS (IRIS) Program

People who inject drugs are at risk of injection-related infections, like abscesses or infective endocarditis. The Injection-Related InfectionS (IRIS) program hopes to improve treatment for participants by providing a low-barrier, one-stop shop model for people who inject drugs who experience injection-related infections to access more holistic and compassionate care. IRIS is a non-randomized clinical trial, meaning that it offers a specific program to eligible patients. This program offers care for substance use and infectious disease with additional peer support and systems navigation, if interested. The investigators anticipate enrolling 80 participants in the intervention and will follow participants throughout the infection treatment period (estimated 6-12 weeks). The investigators will collect information at the time of enrolment, at the 6-month mark, and monthly via electronic medical chart review. The investigators will use an interrupted time series analysis to evaluate the impact of the intervention on rates of treatment completion, emergency department visits, hospitalizations, and death, before versus after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 or older
* Able to provide informed consent
* Presenting with a confirmed or suspected injection-related infection (including skin and soft tissue infections, osteomyelitis, infective endocarditis, Hepatitis C, HIV, etc)
* History of injection drug use within 3 months of recruitment
* Lives in Hamilton, Ontario

Exclusion Criteria:

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Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as autism with irritability

Exclusion Criteria:

* patients who has ever been treated with aripiprazole
Process Validation in Dermatology: Assessing Wound Creation Methods and Treatment Efficacy

The primary objective of this study is to validate controlled methods of wound, including 1%w/v SLS, 3%w/v SLS, and 24-24 times tape stripping, on the forearms of subjects.

The study aims to standardize the procedures for creating wounds and systematically evaluate the effects of these methods on various skin parameters.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is aged between 18 and 55 years (both inclusive) at the time of informed consent.
2. The subject is a healthy adult male, or a non-pregnant, non-lactating, healthy adult female.
3. No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.
4. The subject, if female, has a self-reported negative urine pregnancy test.
5. The subject is in a good general health as determined from recent medical history.
6. The subject has willingness and ability to adhere to study directions, and agrees not to use any other skin creams, lotions, serums, etc. at the application sites, except for the specified test products, and return for all specified visits.
7. The subject possesses the ability to comprehend and provide written informed consent for participation in the study.

Exclusion Criteria:

1. The subject is currently pregnant/lactating or is planning to become pregnant during the study period.
2. The subject has a history of allergies or specific allergic reactions upon using dermatological/cosmetic products.
3. The subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment.
4. The subject suffers from any active clinically significant disease or any condition that according to the investigator's discretion warrants exclusion from the study.
5. The subject is taking or has taken a medication which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis

1. To assess the safety of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis
2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis


Eligibility Criteria:
Inclusion Criteria:

1. Aged 40-80 years (inclusive)
2. Kellgren-Lawrence grading I-III, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee
3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score of 7-17 in the study knee even if treated with chronic doses of non steroidal anti-inflammatory drugs
4. Having provided informed consent

Exclusion Criteria:

1. With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint
2. With previous intra-articular intervention on the target knee joint within past 3 months (e.g. steroid, anaesthetic, sodium hyaluronate)
3. Known or suspected infection of the target knee joint
4. Ascertained hypersensitivity to any component used in the study
5. Administered with systemic anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drug or steroid ) or topical anti-inflammatory drugs on target knee within 7 days prior to administration in the study
6. With serious prior or ongoing medical conditions (e.g. concomitant illness such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, , or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the patient
7. With any evidence of malignant disease with life expectancy of less than 1 year
8. Pregnant or lactating women or planning to be pregnant during the study period
9. With body mass index (BMI) greater or equal to 35 kg/m2
10. With joint diseases except knee osteoarthritis considered by investigator not eligible to enter the study
11. With known history of human immunodeficiency virus (HIV) infection.
12. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
13. With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
14. Having participated other investigational study within 4 weeks of entering this study
15. With known history of claustrophobia
16. Having any existing active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator, etc...
17. Having any existing metallic intraocular foreign body
Migraine and Endothelial Dysfunction

Recently, there is evidence that endothelial activation and dysfunction are associated with migraine, especially in female migraineurs with aura. Our objectives were to determine whether novel endothelial function markers are altered in female migraineurs with aura compared to age-matched controls.

Our objectives were to determine whether novel endothelial function methods and novel markers of endothelial activation are associated with migraine in female migraineurs with aura.

Migraine is an independent risk factor for stroke, especially in young women with aura symptoms. Endothelial dysfunction is a risk factor for cardiovascular diseases. Recent studies suggest that there is a link between migraine with aura and endothelial activation, dysfunction and impaired vascular reactivity.

In this case-control study the investigators examine several novel biomarkers of endothelial function such as endothelial progenitor cells and endothelial microparticles as well as novel methods such as reactive hyperemic peripheral arterial tonometry in female migraineurs with aura and age-matched controls.

Eligibility Criteria:
Inclusion Criteria:

* migraine with aura
* age \< 50
* female gender

Exclusion Criteria:

* severe infectious disease
* cardiovascular disease (stroke, coronary heart disease, myocardial infarction)
* vasculitis
* peripheral artery disease
* diabetes mellitus
* pregnancy
* drug abuse
* medication: statin, anticoagulation, aspirin, clopidogrel
* intake of triptans \<24h
Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis

The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.


Eligibility Criteria:
Inclusion Criteria:

A subject must meet all of the following inclusion criteria to participate in this study:

* Has a diagnosis of juvenile or adolescent idiopathic scoliosis
* Is skeletally immature with a Sanders Score of ≥2 to ≤5
* Has failed conservative care as per investigator's assessment
* Has a main thoracic Cobb angle between 30 and 60 degrees
* Has a Lenke Classification of 1A, 1B, or 1C
* Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative
* Informed Consent Form/Assent and Authorization to Use and Disclose Health Information (if applicable) have been signed by Parent/legal guardian and/or patient/participant per local requirement.

Exclusion Criteria:

A subject will be excluded from participating in this study for any of the following reasons:

* Has undergone previous spinal fusion procedure(s) at the affected levels
* Is pregnant or plans to become pregnant within the first 24-months of the study
* Has a curve that requires instrumentation below L1
* Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord)
* Has any type of non-idiopathic scoliosis
* Has a left-sided curve
* Has an associated syndrome
* Has a history of malignant hyperthermia
* Has an active or significant risk of infection (immunocompromised)
* Has inadequate tissue coverage over the operative site as per investigator's assessment
* Has a suspected or documented allergy or intolerance to implant materials
* Has a major psychiatric disorder / history of drug abuse that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation as per investigator's assessment (DSM-5 can be used as a reference)
* Is a ward of the court/state
* Has had prior ipsilateral or contralateral chest surgery
* Has severe chronic lung disease (e.g., asthma, bronchiectasis)
* Has poor bone quality, as determined by the investigator, that may limit anterior fixation
* Is unwilling or unable to return for follow-up visits and/or follow intra-operative and/or postoperative instructions
* Concurrent participation in another clinical study that may add additional safety risks and/or confound study results