cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study of the Solo™ Insulin Pump

The purpose of this study is to assess the safety and usability of the Solo™ insulin MicroPump in subjects with type 1 diabetes who are pump users.

This is a multi center, one arm, open label and prospective study to assess the safety and usability of the Solo™ MicroPump Insulin Delivery System .

The study will include a 30 days treatment period with the Solo MicroPump with no special care required for maintaining glycemic control and with an optional extension period of up to six month.

The study will consist of up to 5 visits and one follow up phone call one week after termination of the study. In case of participating the extension period, additional visits will consist once a month.

Visit 1 includes eligibility, baseline evaluation and training in handling of the Solo™ System. If no additional practice is required patients will be enrolled. Visit 2 will commence and Solo pump will be filled with insulin. If additional practice is required subject will be sent home for an additional training period of a few days practice using saline and then return for visit 2.

Treatment visits will take place at 3, 14 and 30 days after the enrolment. Additional visits will take place at 60, 90 and 180 days depending on the extension period.

Subjects will be asked to record blood glucose measurements, daily activities and carbohydrate consumptions between visits.

Seven days after termination of study treatment a telephone contact with the study subject will take place for the purpose of adverse event reporting and the completion of DTSQ questionnaire.

Measurements that will be used for assessing the safety of the device are glucose levels and any occurrence of AE's.

Subjects will complete DTSQ and Performance questionnaires before and at the end of the treatment period for usability evaluation.

Blood and urine tests will be taken at visit 1 and 5, vital signs and physical examination will be evaluated at all study visits.

Eligibility Criteria:
Inclusion Criteria:

* Age range of:

  * 18 to 60 years in Israel
  * 16 to 60 years in Austria
* Type I diabetes and pump treatment duration of more than 6 months.
* Subjects who are using Humalog®, NovoRapid®, and Apidra® 100U/ml insulin
* Measures glucose at least four times per day.
* No more than one severe hypoglycemic or ketoacidosis episode within one year
* Willing to sign an informed consent.
* Cooperative, willing to attend all study visits.

Exclusion Criteria:

* A1c \>= 10.0%
* Two or more documented events of severe hypoglycemia within the previous 12 months
* Diabetes related hospitalization over the past 12 months
* Current significant diabetes-related complications
* Pregnant, lactating or planning to become pregnant during the course of the study
* Substance or alcohol abuse
* Uncontrolled hypertension
* Known dermal hypersensitivity to medical adhesive
* Recurrent episodes of skin infections or dermatological allergies
* Serious or unstable medical or psychological conditions
* Current participation in other clinical studies.
* Working for a competitor company
Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD

When a doctor performs Endoscopic retrograde cholangiopancreatography "ERCP" (Endoscopy to examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The tube passes beyond the stomach and into an opening in the liver called the bile duct. Another small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile duct to ensure that there are no cancers or stones in the bile duct and occasionally to take a sample from the bile duct. The purpose of our study is to examine wither performing this procedure can transmit bacteria from the bile duct to the main blood stream.

This is a prospective study to measure the frequency of bacteremia in patients undergoing ERCP with direct cholangioscopic examination of the Common Bile Duct "CBD". A blood culture will be drawn from patients prior to the procedure, 5 minutes after the procedure and 30 minutes after the procedure. The patient will be followed up for 7 days after procedure for fever and sepsis. The estimated sample size is 60 patients.

Eligibility Criteria:
Inclusion Criteria:

* 1- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct to ensure the clearance of the common bile duct from stones.

  2- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for stone removal.

  3- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for tissue acquisition from the common bile duct mass.

  4- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for tissue acquisition from common bile duct strictures.

Exclusion Criteria:

* 1- Patients younger than 18 yrs old or older than 80 yrs. 2- Pregnant patients. 3- Patient with ascending cholangitis, pneumonia or urinary tract infection 4- Patients who received antibiotics in the last 2 weeks prior to the procedure.
Complementary and Alternative Medicine Use in Low-Income African American and Caucasian Adults With Asthma

The purpose of this study is to identify the types of and frequency of use of complementary and alternative medicine (CAM) strategies among low-income Caucasian and African American adults with persistent asthma. The overall goal is to collect data that will increase understanding of health beliefs and behaviors in people with low-income backgrounds so that studies can be created that may help modify and improve patients' symptoms of asthma.

The rates of asthma-related deaths and disease are disproportionately high among African Americans compared to Caucasians. Surveys indicate that middle- and upper-income Caucasians use more CAM than African Americans, but the therapies utilized are different. This study will determine how well people with persistent asthma adhere to their treatment and whether the type and frequency of use of CAM affects treatment adherence.

Participants will begin this study by taking part in an interview about adherence to their current inhaled corticosteroids (ICS) regimen and their personal CAM use. After completing the interview, participant adherence to their ICS regimen will be monitored for 6 weeks. Depending on the type of ICS participants are taking, monitoring will be conducted either by participant self-reporting or electronic monitors that record the time and date of medication inhalation. Participant adherence will also be assessed at study completion.

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma with episodes that last for long periods of time
* Medicaid recipients
* Self-identify as African American or Caucasian
* Daily use of inhaled corticosteroids
* Able to speak English
* Have mental capacity to understand and participate in the study

Exclusion Criteria:

* Prisoners
* History of smoking at least ten packs of cigarettes per year
* Currently smoke more than one and a half packs of cigarettes per week
Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

The primary objective of this study is to determine the retention rate over a two month period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 40 and 70 years of age.
4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to +2.00 in each eye.
5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
6. The subject's ADD power must be in the range of +0.75 D to +2.50.
7. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies that contraindicate contact lens wear.
3. Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates contact lens wear.
4. Any ocular abnormality that may interfere with contact lens wear.
5. Use of any ocular medication, with the exception of rewetting drops.
6. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
7. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
8. History of herpetic keratitis.
9. Any ocular infection or inflammation.
10. Any corneal distortion or irregular cornea.
11. History of binocular vision abnormality or strabismus.
12. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
13. History of diabetes.
14. Current or previous history of being prescribed a correction for distance vision.
15. Current or previous history of contact lens wear.
16. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Periodontal Disease and Colorectal Cancer

The aim of this interventional study is to determine the impact of periodontal disease and periodontal treatment on patients with colorectal cancer.

The main questions were:

1. Does periodontal treatment affect the levels of C-reactive protein in the blood of patients undergoing cancer treatment?
2. Can the investigators isolate periodontal pathogenic bacteria Fusobacterium nucleatum and Porphyromonas gingivalis from the mucosa of cancerous colon tissue using the method of quantitative culture?

The investigators will compare the levels of C-reactive protein in the blood of patients undergoing treatment for colorectal cancer who have received periodontal treatment with patients who have not received periodontal treatment. CRP levels will be measured during the first examination with the oncological surgeon, on the first and second day after the surgical procedure, and during the first follow-up with the oncological surgeon.

Additionally, the investigators collected samples of cancerous colon mucosa from 10 participants for the attempt to isolate F. nucleatum and P. gingivalis using the quantitative culture method.


Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer, scheduled for surgical treatment
* consent to participate

Additional inclusion Criteria fot the control group:

* fiilled questionnaire
* Recorded CRP results at the first examination, after surgery, and at the first follow-up examination.

Exclusion Criteria:

* under 18 years old
* periodontal treatment in the past 12 months
* antibiotic therapy in the last 3 months
* edentulism
* advanced stage cancer, scheduled for palliative care
* chemotherapy or radiotherapy prior to surgical procedure
Global Lomitapide Pregnancy Exposure Registry

To evaluate the outcomes of pregnancy in women treated with lomitapide.

To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females exposed to lomitapide at any time within 30 days prior to first day of the LMP or during pregnancy.

Exclusion Criteria:

* Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.
Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg


Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* 18-65 years of age
* Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
* Body weight 45 kg or greater, with a body mass index (BMI) ≤ 35 kg/m² (weight \[kg\]/height\[meters\]²)

Exclusion Criteria:

* If female, of childbearing potential or lactation
* History of significant adverse reaction to any lipid-lowering agent
Quality of Sexual Life of PrEP Users

The study will recruit participants on the occasion of their visit in a sexual health center or another HIV pre-exposure prophylaxis (PrEP) facility in France.

PrEP users will be proposed to fill a self-administered, online, anonymous questionnaire regarding how they perceive different fields of their sexual life, and how they perceive that PrEP has an impact on the quality of sexual life.

PrEP aims to protect against HIV; more broadly, PrEP is a holistic process, addressing vaccination (hepatitis A, hepatitis B, human papillomavirus, MPox), sexually transmitted infection diagnosis, mental health, issues related to psychoactive substance use, etc.

This process is likely to impact not only "classical" health areas, but also fields concerning more widely the quality of life.

In particular, the investigators emit the hypothesis that PrEP is associated with an increase of the quality of sexual life.

the investigators have therefore designed a study based on a self-administered anonymous questionnaire to explore how PrEP user evaluate their quality of sexual life and how they perceive the impact of PrEP on this topic.

Adult PrEP users will be recruited through billboard in sexual health center or another PrEP facility in France. A QR (quick response) code will be displayed, giving access to the questionnaire.

Participation to the study is limited to fill once the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* current PrEP use
* adult

Exclusion Criteria:

* unwilling to participate
Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing recurrent acute sinusitis in children.

A Prospective, Randomized, Double-blind, Placebo Controlled Trial of azithromycin in preventing recurrent acute sinusitis in children

Eligibility Criteria:
Inclusion Criteria:

* children between the age of 5 years and 15 years with the diagnosis of recurrent acute sinusitis who are attending the outpatient pediatric department, pediatric allergy clinic, and the ear, nose, throat clinic.

Exclusion Criteria:

* patients who have allergic rhinitis, chronic sinusitis, a history of allergic reactions to azithromycin or macrolides, treatments with immunotherapy or IVIG or gentamycin solution or pneumococcal vaccine during study period.
Quantitative MRI in Assessing Disease in Patients With Brain Tumors

This pilot clinical trial studies quantitative magnetic resonance imaging (MRI) at 3 Tesla in assessing disease in patients with tumors that have spread to the brain (brain metastases). In addition to routine care brain imaging of the brain, this study will include advanced multiparametric MRI sequences to measure vascular, cellular, and molecular properties of the tumor. Performing extra scans during MRI provides more information about the metastases and may better predict treatment response.

PRIMARY OBJECTIVES:

I. To correlate pre-treatment measures of biophysical parameters in metastases-obtained using advanced, quantitative MRI techniques in patients receiving standard-of-care (SOC) therapy for 1-4 brain metastases-with treatment-induced changes in lesion size, time-to-progression (TTP), and overall survival (OS).

OUTLINE:

Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, diffusion-weighted (DW)-MRI, chemical exchange saturation transfer (CEST), and combined dynamic contrast enhanced (DCE)-MRI/dynamic susceptibility contrast (DSC)-MRI at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Patients must sign an Institutional Review Board (IRB)-approved informed consent document
* Patients must have been diagnosed with one of the following:

  * Primary brain tumor (glioma, GBM etc); or
  * Up to 10 brain metastases
* Patients must have been diagnosed with 1-4 brain metastases
* At least one of the brain metastases must measure 5 mm (or more) in short axis diameter in the axial plane
* Patients must be scheduled to undergo standard brain cancer interventions:

  * Chemotherapy or targeted antiangiogenic therapy, in the case of primary brain tumor; or
  * Stereotaxic radiotherapy (SRS) or whole brain radiotherapy (WBRT), in the case of brain metastases.
* Patients must be scheduled to receive a 3-Tesla (3T) MRI exam as part of their standard of care (this exam will be modified to also include pulse sequences with are for research only)

Exclusion Criteria:

* Patients who have received previous treatment (chemotherapy or radiotherapy) for any brain tumor (primary or metastatic).
* Patients who are scheduled to receive a 1.5T MRI exam
* Patients incapable of giving informed written consent, due to mental disability, altered mental status, confusion, cognitive impairment, or psychiatric disorders.
* Patients scoring 14.5 or lower on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) questionnaire will not be allowed on the study
Ga68-DOTA-NOC-PET Imaging of Neuroendocrine Tumors

Imaging of neuroendocrine tumors (NETs) relies on conventional morphological methods and on somatostatin receptor scintigraphy (SRS). SRS is effective for carcinoid tumors, and for most pancreatic islet-cell tumors, but may fail to detect some tumors. Furthermore, this technique may require repeated imaging over 24-48 hours. Introduction of newer somatostatin analogs such as DOTANOC improves lesion detection. In addition, labeling with Ga68 and use of PET/CT improves the pharmacokinetics of the tracer resulting in better tumor visualization, and an easier procedure with imaging over only 1-2 hours.

In this study, we propose to use Ga68-DOTANOC PET for imaging of various NETs, comparing the imaging data to those of anatomical and other functional modalities, and to histopathology, when available.

Neuroendocrine tumors (NETs), best treated by complete surgical resection, are frequently difficult to localize due to small size, presence in hollow organs, and morphological changes caused by prior surgery. Imaging of NETs relies primarily on conventional morphological methods (EUS, CT, MRI, US). Functional imaging, such as somatostatin receptor scintigraphy (SRS) using the In111-labeled somatostatin analog octreotide, provides better staging of the disease, visualization of occult tumor, and evaluation of patient eligibility for somatostatin analog treatment. This modality is effective for carcinoid tumors, and for most pancreatic islet-cell tumors. However, it may fail to detect some tumors, mostly due to low density of somatostatin receptors, with resulting lack of tumor uptake. The relatively poor spatial resolution of planar and SPECT imaging may also reduce tumor detection, particularly for small tumors and/or those with low uptake. Furthermore, this technique is lengthy, often requiring repeated imaging over 24-48 hours. Introduction of newer somatostatin analogs such as DOTANOC offers many advantages. Higher uptake of the newer analogs in more of the somatostatin receptor subtypes improves lesion detection. In addition, labeling with the positron emitter, Ga68, instead of In111 improves the pharmacokinetics of the tracer, and the faster tumor uptake and more rapid clearance from normal tissues increases tumor to background contrast, improving tumor visualization, and resulting in an easier procedure with imaging only 1-2 hours after tracer injection. The superior spatial resolution of positron emission tomography (PET) again enhances lesion detectability, and use of PET makes it possible to perform exact quantitation of tracer uptake that can be useful for monitoring therapy and for planning peptide receptor radionuclide therapy.

In this study, we propose to use Ga68-DOTANOC PET for imaging of various NETs, comparing the imaging data to those of anatomical and other functional modalities, and to histopathology, when available.

Eligibility Criteria:
Inclusion Criteria:

* neuroendocrine tumor
* patients who are able to lie in scanner for up to 50 minutes

Exclusion Criteria:

* under age 18
* pregnant or lactating women
COVID-19 Vaccine Uptake Trial

The goal of this study is to assess the best COVID-19 vaccine uptake strategy among students, staff and household members that have not been vaccinated.

There is a multitude of recommendations present that highlight different vaccination strategy; however, it is still unclear which strategy is best to increase COVID-19 vaccination rates. We will compare the effectiveness and acceptance of two different communication strategies among unvaccinated students, staff, and their household members.

A sequential multiple assignment randomized trial (SMART) will be conducted to assess two strategies to increase COVID-19 vaccine uptake. The two strategies that will be assessed are a text message with a link to an information website and peer-based motivational interview. If individuals do not seek vaccination after the first intervention, they will again be randomized into the same two interventions. This will allow for testing of both interventions as well as understanding if the use of a more intense intervention (two 'doses') is optimal for vaccine uptake.

In addition, SARS-CoV-2 saliva-based testing will be conducted among students, staff, and household members from the summer of 2022 through the first semester of the 2022-2023 school year. As the pandemic is in its third year, the use of testing among students, staff, and their household members will be assessed Individuals are eligible to be tested multiple times and the testing will occur along different timelines.

Eligibility Criteria:
Inclusion Criteria:

1. Is not up to date with their COVID-19 vaccinations per CDC guidelines
2. is considered eligible by the CDC at the time of enrollment to receive a COVID-19 vaccine
3. is a staff, student, or household member of staff or student of one of the participating school districts OR a resident of St. Louis City or St. Louis County

Exclusion Criteria:

1. Is currently up to date with their COVID-19 vaccinations per CDC guidelines
2. ineligible to receive any COVID-19 vaccine due to medical history or age
3. is not a staff or student, or household member of staff or student of one of the participating school districts AND is not a resident of St. Louis City or St. Louis County
4. participant (or their parents/LAR) do not provide consent.