cyrilzakka/clinical-trials huggingface dataset:
Periodic Use of Continuous Glucose Monitoring With Personalized Diet Interventions Using AI Camera Among Non-insulin Treated Type 2 Diabetes

The aim of this study is to evaluate the periodic use of continuous glucose monitoring (CGM) with an AI camera and following diet education among non-insulin-treated type 2 diabetes patients.

The control group used self-monitoring blood glucose (SMBG) for two weeks with a manual food diary followed by diet education and repeated SMBG with a food diary three months later. Treatment 1 group used CGM (Freestyle Libre) for two weeks with an AI food camera followed by diet education, and repeated CGM for two weeks with an AI food camera three months later. Treatment 2 group used CGM for two weeks with an AI food camera followed by diet education without repeat three months later. Every group followed at 6 months for the final outcome. HbA1c at 6 months is the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes patients
2. HbA1c 6.5% - 10%
3. No medication changes in the past 3 months, and receiving treatment with lifestyle modification or oral antidiabetic drugs or GLP-1 receptor agonists
4. Ages 18 - 80 years old

Exclusion Criteria:

1. Insulin users
2. Those who have used steroids within the past 3 months or are expected to use them during the study period (excluding ointments)
3. Type 1 diabetes patients
4. Patients who have undergone pancreatic resection
5. Patients undergoing hemodialysis or peritoneal dialysis
6. Those requiring continuous MRI and CT scans
7. Those deemed by the researcher to have difficulty handling continuous glucose monitors and AI cameras
8. Those deemed unsuitable for participation in this clinical trial by the investigator, other than those mentioned above
9. Pregnant women
Surgery Plus Radiation Therapy With or Without Chemotherapy in Treating Children With Primitive Neuroectodermal Tumors of the CNS

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether undergoing surgery plus radiation therapy is more effective with or without chemotherapy for primitive neuroectodermal tumors of the CNS.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus radiation therapy with or without chemotherapy in treating patients who have primitive neuroectodermal tumors of the CNS.

OBJECTIVES: I. Determine whether chemotherapy utilizing carboplatin, vincristine, cyclophosphamide, and etoposide improves the prognosis for children with primitive neuroectodermal tumors of the central nervous system when given after surgery and before radiotherapy. II. Assess prospective factors that may determine ultimate prognosis in this patient population. III. Determine the quality of survival of these patients on both treatment regimens.

OUTLINE: This is a randomized study. Patients undergo surgical removal of the primary tumor. Following surgery, patients are randomized to receive radiotherapy alone (arm I) or chemotherapy followed by radiotherapy (arm II). Arm I: Patients begin receiving radiotherapy as soon as possible after surgery, within 28 days. Radiotherapy is administered 5 times a week for 6 weeks. Arm II: Within 28 days of surgery, patients receive vincristine IV on days 1, 7, 14, 21, 28, 35, 42, 49, 56, and 63. Carboplatin IV is administered over 1 hour on days 1, 2, 42, and 43. Etoposide IV is administered over 1 hour on days 1-3, 21-23, 42-44, and 63-65. Cyclophosphamide IV is administered over 4 hours on days 21 and 63. As soon as possible after chemotherapy, patients receive radiotherapy as in arm I. Quality of life is assessed every 3 months for the first year and annually thereafter. Patients are followed every 6 weeks for the first year, every 3 months for the second year, every 4 months for the third year, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven primitive neuroectodermal tumors of the central nervous system No metastatic disease within or outside the central nervous system Must have survived 1 week following surgery Postoperative CT scan and myelogram required

PATIENT CHARACTERISTICS: Age: 3 to 16 Performance status: Not specified Life expectancy: Not specified Hematopoietic: No concurrent hematological disorder Hepatic: Not specified Renal: Renal dysfunction allowed Other: No prior history of malignant disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients

The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects and guardians are willing to sign the informed consent.
2. Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length≥3cm.
3. 6 years old ≤ age ≤17 years old , Male or female.
4. ASA Physical Status Classification I-III.

Exclusion Criteria:

1. Subjects received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days;
2. Subjects with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, AIDS or malignant tumors) or received immunosuppressants within 30 days;
3. Subjects with comorbid mental diseases (such as schizophrenia, depression, etc.) or difficult to communicate;
4. Subjects with a history of chronic pain or visceral pain;
5. Subjects with abnormal liver and kidney function;
6. Subjects with clinically significant abnormal heart rate or rhythm;
7. Subjects who are participating or planning to participate in any interventional clinical trial;
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy

Venn Biosciences Corporation ("InterVenn") has developed a liquid biopsy that is capable of distinguishing benign from malignant masses in women presenting with adnexal (pelvic) masses, through a simple blood test. The underlying technology combines mass spectrometry and artificial intelligence/machine learning to analyze tumor-associated changes in circulating glycoproteins.

The purpose of this study is to prospectively collect de-identified biological samples and data from women with a known pelvic mass, in order to validate ovarian cancer specific glycoproteomic signatures in the blood based on histologically confirmed malignancy status of the mass.

This is a prospective, international, multi-center, observational study with a goal of collecting de-identified samples and data from 1,200 women with a known pelvic mass. Participants will consent to baseline and follow-up data and biospecimen collections.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18 years or older
* Able to provide a written informed consent and who understand and agree to all study procedures required
* A newly diagnosed adnexal mass as confirmed by imaging (computed tomography, ultrasonography, or magnetic resonance imaging) prior to enrollment
* Planned diagnostic procedure or surgery by the subject's physician to remove adnexal masses within 90 days of imaging. (Note that diagnostic procedure typically includes biopsy (needle core or laparoscopic-directed), ascites cytology, pleural effusion cytology or FNA)

Exclusion Criteria:

* Had/Has a diagnosis of invasive malignancy (exception: non-melanoma skin cancers) in the previous 5 years.
* Currently receiving or ever received any of the following prior cancer therapies in the previous 5 years. This includes curative surgical resection, local or systemic chemotherapy, targeted therapy, immunotherapy including cancer vaccines, hormone therapy, and/or radiation therapy.
* Pregnancy
* Current febrile illness
* Acute exacerbation or flare of an inflammatory condition requiring escalation in therapy
* Recipient of organ transplant
* Poor health status or unfit to tolerate blood draw

In addition, this study will include a small subgroup of women with a newly diagnosed clinically benign adnexal mass(es) for whom surgery is not planned as determined by the treating physician. This subgroup will follow the same exclusion criteria as listed above.
Use of Erythromycin in Mustard-Induced Bronchiolitis

We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis obliterans


Eligibility Criteria:
Inclusion Criteria:

* Documented chemical exposure
* Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT)
* Non-responsiveness to high dose bronchodilator therapy

Exclusion Criteria:

* Radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic
* History of cigarette smoking and occupational exposure to toxic agents of hypersensitivity to macrolides
* History of treatment with a systemic antibiotic within 7 days before the start of the study
* Any investigational medicine within 4 weeks of the study
* History of antibiotic injection within 6 weeks before the study
* Concomitant Theophylline or Carbamazepine, unless their serum concentrations were regularly monitored
* Patients who were in the exacerbation phase of their respiratory complications
* Need to use medications interact with macrolides such as Digoxin, Theophylline and Carbamazepine
* Systemic antibiotics
* Systemic Corticosteroids
* Admission to the hospital
* Abnormal kidney or liver function
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors

The purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor/AI and denosumab. The study team will collect information from 5 standard clinic visits over the course of 24 months. The information will include information about participant health assessments, blood test results, and imaging results. After 24 months, participation in this study will be complete.


Eligibility Criteria:
Inclusion Criteria:

* Women with confirmed diagnosis of breast cancer
* Participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment
* Received at least 2 doses of denosumab and then discontinued therapy
* Discontinued AI prior to or within 6 months of last denosumab injection
* Patients must be 18 years of age or olde

Exclusion Criteria:

* Patients with history of osteoporosis prior to starting denosumab, based on previous dual-energy X-ray absorptiometry (DEXA) scan;
* Patients with history of insufficiency fracture.
* Patients who continue treatment with a different bone modifying agent (i.e oral or intravenous bisphosphonates) after discontinuation of denosumab
* Patients on chronic low-dose glucosteroids.
SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM

The purpose of this study is to test whether or not the 4 Pillars Toolkit increases adult Influenza, pneumococcal polysaccharide vaccine (PPSV), tetanus, adult diphtheria and acellular pertussis vaccine (Tdap/Td) vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to national guidelines. The investigators will conduct a randomized cluster trial of this toolkit in diverse primary care practice with electronic medical records (EMRs).

This intervention is a two-region, two-year, stratified randomized cluster trial in 24 primary care practices with EMRs. These practices will be randomly assigned to be intervention or control sites to test this 4 Pillars Toolkit intervention package of evidence-based techniques tailored to their practice structure and culture; one set of practices randomized to intervention in year 1 and the other to control. In year 2, the other set of practices will receive the intervention and community controls may be sought.

These diverse practices consist of: 18 diverse practices from UPMC in western Pennsylvania and 6 diverse practices from large community health centers in a PBRN in Texas.

Eligibility Criteria:
Practice staff and adults in enrolled clinical sites

Inclusion Criteria:

Site inclusion criteria:

* 1) an appropriate adult population: e.g., adults aged 50 years and older;
* 2) currently using an EMR that has prompt ability, such as EpicCare;
* 3) having and keeping immunization data within this EMR

Patient-level inclusion criteria:

* 1) Adults (18 years and above) who are active patients of the enrolled practices (e.g., active patients are those with a visit within the last 12 months)
* 2) All unvaccinated adults without a contraindication are eligible to receive Td/Tdap and influenza, regardless of age and at age 65 years or older are eligible for PPSV.

Exclusion Criteria:

Site exclusion criteria:

* 1) consistent SOP use for the 3 vaccines being studied or high vaccination rates (e.g., 80%)

Patient-level exclusion criteria:

* 1) those with a true contraindication, following the CDC's Guide to Contraindications (attached with the US Recommended Adult Immunization Schedule), such as prior vaccine anaphylaxis.
Examination Of Vitiligo Skin Samples Before and After UVB Treatment

The keratinocytes of lesional skin of vitiligo compared to normal and perilesional skin will differentially express genes correlating with melanocyte death. Narrow Band UVB should then hopefully reverse the pattern of gene expression back toward normal.

Vitiligo is a disease caused by the disappearance of melanocytes in the epidermis. The pathogenesis of vitiligo is multifactorial. Theories include autoimmunity, neural, apoptosis and cytotoxicity. The medical treatments for vitiligo are marginal with a 40-60% response rate which does not guarantee full repigmentation. Understanding the pathogenesis of vitiligo will allow better targets for treatment.

Previous analysis of skin biopsies have found several of the changes in gene expression occurred in immune regulation, DNA replication and repair, oncogenes, signal transducers and transcription factors. These results give us insight as to what happens in lesional vs nonlesional skin which contains the epidermis, dermis, fat, blood vessels and immune cells.

We have the technology today to study specific cell populations from tissue by the use of laser capture microdissection. We propose to use this technique to study the keratinocyte population in vitiligo skin because past evidence suggests that they may play a role. In addition, the role keratinocytes in vitiligo may be important for treatment as this would be the ideal target for therapy. Keratinocytes have been studied in vitiligo.

The aim of the study is to isolate keratinocytes from normal skin, perilesional and lesional skin in vitiligo patients by laser capture microdissection and characterize their gene expression profile by gene microarray analysis and to compare keratinocyte gene expression in normal, perilesional and lesional vitiligo skin before and after narrow band UVB treatment.

Eligibility Criteria:
Inclusion Criteria:

Patients should have non-treated symmetrically active vitiligo for 3 months.

Exclusion Criteria:

Less than 18 years old and older that 65, pregnant women, segmental or nonactive vitiligo, patients treated for vitiligo in past 3 month, patients on topical steroid medications, topical tacrolimus or elidel, patients receiving ultraviolet therapy including narrow band UVB, PUVA or tanning beds.
Safety and Performance of Short- and Long-term Baseplates for Attaching the Marco Recorder

The purpose of this clinical investigation is to test the safety and performance of short- and longterm Baseplates constructed with different types of biocompatible adhesives.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained, and letter of authority signed before any study related activities
* Are at least 18 years of age and have full legal capacity
* Healthy skin behind the ear

Exclusion Criteria:

* Pregnant or breastfeeding
* Known allergic responses to the adhesives
* Treatment with corticosteroids, either as a cream in the area behind the ear or systemically (tablet or injection) within the last month
* Subject is unable or does not have the necessary assistance to properly operate the device system
Interest of Prior Relaxation on the Recordings of the SomatoSensory Evoked Potentials

Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of the patient to electrical stimuli making the examination unpleasant; examination time considered too long. However, the patient's relaxed state is essential to the quality of the signal . Thus the duration of an examination is very variable : between 30 and 75 minutes for the upper limbs.... For several months, the investigators provide relaxation to some patients just before the examination. Results seem to be positive. The investigators aim to study the effect of relaxation session on the quality of the SSEP recordings. Fifteen-minutes relaxation session will be provided by a nurse trained to the relaxation.

The investigators will compare two groups : one group with one relaxation session before the examination and one group without relaxation session before the examination.

The investigators chose to study the influence of relaxation session on (i) the artifacts rejection rate by the machine for the recordings of SSEP by stimulation of the median nerve to the upper limbs (ii) the duration of the examination (iii) the patient experience


Eligibility Criteria:
Inclusion Criteria:

* Any patient addressed for a study of the somatosensory evoked potentials in upper limbs
* Patients between 18 to 70 years old.
* Patients able to understand the instructions of the relaxation session and the examination.
* Patient providing informed consent exclusion criteria

Exclusion Criteria:

* No availability of a technician trained in relaxation
* Patient's refusal to participate in the protocol
EsophaCap for the Detection of Early Esophageal Carcinoma

This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma), and gastric cancer via sponge cytology.

This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma). Esophageal and gastric cytology will be collected via sponge capsule. Candidate genes will be tested with DNA isolated from these samples in order to identify optimal biomarkers to differentiate between Barrett's esophagus and esophageal/gastric cancer versus normal esophageal/gastric tissue.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing esophagogastroduodenoscopy at Johns Hopkins Hospital from 1/2016 to 12/2025
* Age greater than 18 years
* Patients must be able to swallow a capsule

Exclusion Criteria:

* Patients in either arm with extra-esophageal malignancies including head and neck and gastric cancer
* Patients who have undergone esophagectomy
* Patients who have undergone radiation to the chest
* Patients who are younger than 18
* Patients with esophageal stents
* Patients with esophageal strictures disabling passage of the capsule
Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors

This is a prospective observational study of vaccine efficacy and safety in adult patients with malignancies (melanoma/Hodgkin's lymphoma/Non-small cell lung cancer). The primary objective is to compare serotype specific immunoglobulin G (IgG) antibody titres before and after pneumococcal vaccination in patients receiving Immune Checkpoint Inhibitors (ICI). As an explorative objective, serotype specific IgG antibodies measured by ELISA and those measured by Opsonophagocytosis assay (OPA) after pneumococcal vaccination in patients receiving ICI will be correlated. In addition, the incidence of immune related adverse events (irAE) in patients vaccinated during ICI treatment will be determined.

Physicians will be informed by mail and pocket cards with all necessary information about the study, in particular eligibility criteria. Patients currently receiving Immune Checkpoint Inhibitors will be approached by their treating physicians in case of an already scheduled vaccination against S. pneumonia. If a patient agrees to participate in the study and to sign an informed consent form, basic data on demographics, underlying disease, comorbidities, and irAE will be obtained from the electronic health record and entered into the eCRF.

Pneumococcal antibody titers will be drawn at baseline and after 30 days. We will actively follow-up on study patients for four months after enrolment and screen health records of the enrolled patients after four months to record occurrence of irAE.

A blood sample (9 ml) will be drawn before vaccination. Vaccination will either be performed by the treating physician or by a general practitioner. After 30 days, a second blood sample will be taken during an already planned visit at the (outpatient) clinic. Titer assessment will be performed along STIKO recommendations for immunocompromised patients.

All samples for ELISA and OPA titer determination will be stored frozen at Department I for Internal Medicine and titers will be analyzed in batch at the end of this study. All therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (RKI STIKO recommendations).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Age ≥18 years
* Receiving pneumococcal vaccination for the first time along STIKO criteria
* Therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agentfor melanoma, NSCLC or other malignancy

Exclusion Criteria:

* Patients unwilling/ineligible for vaccination under current STIKO recommendations
* Previous vaccination with any licensed or experimental pneumococcal vaccine
* Concurrent treatment with anti-CTLA-4 agent