cyrilzakka/clinical-trials huggingface dataset:
Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials

This study explores the overall feasibility, impact, and satisfaction of using the "mHealth app" on clinic workflow for Black or African American women diagnosed with breast cancer.

The "mHealth app" which can be used as a platform to share clinical trial education and communication, was created and tested in previous steps of this study.

A patient advisory council (PAC) was recruited from established hospital and community networks (North Carolina Cancer Hospital's Patient and Family Advisory Board, and the Lineberger Community Outreach and Engagement Office's Community Advisory Board). The PAC informed the content of interview guides, questionnaire/survey instruments, and mHealth app design, and will be involved in the analyses of qualitative and quantitative data, and dissemination of study results.

After analysis of the in-depth interviews, the Connected Health for Applications and Interventions (CHAI) core staff developed a progressive web application "mHealth app". mHealth app was tested in a pilot study included 20 African American (AA) patients diagnosed with breast cancer were interviewed to answer questions that will better inform the clinical trial education and communication needs of Black women with breast cancer.

Eighty African American women with newly diagnosed breast cancer who have access to a mobile device or computer will be recruited for the study intervention. Women will receive access to the "mHealth" app, a list of available clinical trials within a 50-mile radius of their zip code, and the existing standard of care packet of cancer center resources. Participants will complete a brief questionnaire that will assess clinical trial knowledge, how often a clinical trial discussion occurred during their oncology appointment, and if a therapeutic trial was offered.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English speaking
* Able and willing to participate to complete the survey.
* Have access to a mobile device or computer.
* Diagnosed with breast cancer.
* Identify as African American

Exclusion Criteria:

* Inability to read and speak English.
* Dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
ELECT Trial - Embolization of the Lumbar Arteries Before EVAR

Prospective, Randomized, Single-center Study for the Treatment of Subjects with Abdominal Aortic Aneurysm: Embolization of the Lumbar Arteries Before EVAR: A Prospectively Randomized Trial Comparing Platinum-Fibered Microcoils (control arm) with the MVP® Microvascular Plug (study arm)"

This study is a prospective, single-center, 1:1 randomized trial to investigate the difference in radiation dose and intervention time between the embolization with FCP and MVP-Plug.

Eligibility Criteria:
Inclusion Criteria:

1. Subject age ≥ 18
2. Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
3. Indication for the occlusion of lumbar arteries due to:

   1. Subject has an abdominal aortic aneurysm and
   2. At least 2 patent lumbar arteries in the diseased area
4. Subject understands the duration of the study, agrees to attend the stentgraft implantation
5. A microcatheter is successfully placed the target lumbar artery.

Exclusion Criteria:

1. Any surgical procedure or intervention performed within 30 days prior to or post index procedure
2. Aortic aneurysm requires treatment with alternative therapies such as operation
3. any other aortic pathology
4. major untreated cardio-pulmonary disease
5. life-expectancy of less than one year
6. expected lack of compliance (e.g. if the patient may not be willing to have several sessions and the following repair done)
7. pregnant or nursing women
8. impaired thyroid function, if not under stable treatment
9. women of child-bearing potential without highly effective contraceptive measures
10. Enrolled in another investigational drug, device or biologic study
11. Failure to successfully intubate an lumbar artery
12. Stroke or heart attack within 3 months prior to enrollment
13. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
14. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
15. Platelet count \<100,000 mm3 or \>600,000 mm3
16. Receiving dialysis or immunosuppressant therapy
17. Chronic kidney disease (serum creatinine \> 2.5 mg/dL)
Trial of Levofloxacin as Prophylaxis After Allogeneic Stem Cell Transplantation (SCT)

The purpose of this study is to evaluate the efficacy of levofloxacin to prevent bacterial infections in the postneutropenic period in patients who have undergone allogeneic stem cell transplantation (SCT).


Eligibility Criteria:
Inclusion Criteria:

* Allogeneic SCT
* Postneutropenic period
* Written consent

Exclusion Criteria:

* Fever
* Antibiotic therapy
* Neutropenia
* Refusal by the patient
A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product

This protocol intends to detail investigations necessary to evaluate the ocular safety of subjects enrolled in study A4321001 and who have received formulated Drug Product (Lot 8716-098).


Eligibility Criteria:
Inclusion Criteria:

* A subset of subjects enrolled in study A4321001 and who have received formulated drug product (Lot 8716-098) will be included in the safety follow up study.

Exclusion Criteria:

None
Intra-abdominal Umbilical Vein Aneurysm

The purpose of this study is to investigate the ultrasound characteristics and outcome of pregnancies with fetal Intra-abdominal umbilical vein aneurysm.

Intra-abdominal umbilical vein aneurysm is a rare pathology of the fetal venous system. Its incidence is low, evaluated between 0.4 and 1.1 / 1000.

Intra-abdominal umbilical vein aneurysm is identified as an oval or rounded, anechoic mass located between the abdominal wall and the lower edge of the liver.

It is defined by two criteria: either a diameter greater than 9 mm or a diameter of the subhepatic segment of the umbilical vein greater than 50% of the diameter of its intrahepatic segment.

The complications that can occur during pregnancy are mainly represented by the MFIU, the occurrence of thrombosis and intrauterine growth retardation (IUGR). Their overall frequency is evaluated at 10%.

A complete fetal morphological assessment is necessary to eliminate the presence of other lesions. However, ultrasound monitoring is recommended during the third trimester in search of an increase in dilation and especially the appearance of a thrombus. A particular clinical form, related to abnormal umbilical vein involvement in the infra-hepatic portal system, must be individualized because of a high risk of thrombosis. It justifies the realization of an abdominal ultrasound in the first days of life

Eligibility Criteria:
Inclusion Criteria:

* All patients who have AVO partially intra-abdominal isolated or associated with other abnormalities.
* Patients over the age of 18 who agree to participate in the study after oral information given by the sonographer.
* Any patient seen in 1st intention or 2nd intention.
* Gestational age between 20 and 35 weeks

Exclusion Criteria:

* Patient refusing to participate in the study.
Accuracy of Dynamic Navigation System on Zygomatic Implant Placement

This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in zygomatic implant placement in partially or total edentulous patients in the upper jaw compared with the conventional freehand method.

The present study is a prospective randomized clinical trial.

Each patient enrolled in this trial will be randomly allocated to on group (Navigation group (test group) or Freehand group (control group)). Preoperative virtual planification of zygomatic an conventional implants on a prerequired cone beam computed tomography (CBCT) with radiographic markers (tooth if possible or micro implants if not possible) will be performed for each patient.

The patient will be randomly allocated in one group just before the surgery, and the surgical procedure will be performed according the surgery protocol of each group. Then, after the surgical procedure a PROMs questionnaire will be asked to the patients.

Finally a postoperative CBCT will be performed and overlapped with the preoperative CBCT with the implants planification and implant position deviations between the planned and final position will be measured.

The study devices are European Conformity (CE) marked products and used within their intended use.

Eligibility Criteria:
Inclusion Criteria:

* Partial or total edentulous maxilla
* Large bone atrophy that avoids possible conventional implant placement
* Over 18 years old patients

Exclusion Criteria:

* Patients with facial bone disease that contraindicates conventional or zygomatic implants placement.
* Systemic or local conditions that contraindicates oral surgery.
Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unbAmbiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Impacts of Kebbi Robot Intervention for Older Adults with Mild Dementia

The goal of this clinical trial is to examine the immediate and sustained effects of an intensive Kebbi robot intervention on cognitive functions, heart rate variability (HRV), and psychological changes for older adults with mild dementia in long-term care (LTC). The main questions it aims to answer are:

* Are intensive Kebbi robot interventions effective in improving cognitive functions, HRV, and psychological changes for older adults with mild dementia in LTC?
* What are the participants\&#39; experiences and perceptions after intensive Kebbi robot interventions? Researchers will compare intensive Kebbi robot interventions to a control group (receiving usual activity) to see if they are effective in improving cognitive functions, HRV, and psychological changes in older adults with mild dementia in LTC.

Participants will:

* Participants in the intensive Kebbi robot interventions will receive 30 minutes, thrice weekly, for 12 weeks. Participants in the control group will receive the usual activity.
* The outcome measures will be conducted at three time points: before the intervention (T0), immediately after the end of the intervention (T1), and one month after the end of the intervention (T2).
* Outcome measurements include the cognitive outcomes: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Finger Tapping Test (FTT); heart rate variability (HRV); psychological changes: the Geriatric depression scale-short form (GDS-SF), the UCLA Loneliness Scale Version 3 (UCLA- Version 3), and the Friendship scale.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 years or over;
* mild dementia (MMSE score between (19-24) according to level of education;
* an ability to communicate in Mandarin or Taiwanese;
* has been admitted in dementia daycare centers at least 3 months.

Exclusion Criteria:

* have severe difficulty in communication;
* are totally dependent on carers for daily activity;
* have a diagnosed infectious disease, moderate or severe dementia, and severe mental illness such as schizophrenia and delusional disorder
Rapid Processing and Immunohistochemistry Method for Optimising Diagnosis Time in Solid Organ Donors, Suspected Malignancy

Comparison of the diagnostic yield of intra-operative histological analysis of donor tissue with suspected neoplasia performed with the standard method versus the experimental method, which involves optimisation of sample freezing and analysis with the IHC fast track procedure

Optimisation of frozen material can be achieved with specific tools that improve the quality of freezing and the cutting of histological sections, allowing a lower incidence of artefacts, with better histological definition. These instruments would also allow the execution of automated IHC protocols, with increased diagnostic sensitivity and specificity and better risk stratification for donors with malignancy. All this should lead to an increase in the donor pool with better oncological risk stratification and, consequently, increase the number of organs to be allocated, making it possible to respond more promptly to the great demand for organs needed for transplantation.

Moreover, not only would the certain exclusion of a neoplasm allow the use of donors who would otherwise have been considered to be at unacceptable risk and therefore excluded from the donor process, but a more precise diagnosis of the neoplasm (where present) would allow the second opinion to stratify the risk more accurately, with a more rational use of organs.

All organ donors who request extemporaneous intraoperative examinations to define the oncological risk of donation during the study period will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Organ donors (legally dead by brain or cardiac death) with suspected neoplasia.
* Sending organs/tissues of all types and locations for extemporaneous examination request

Exclusion Criteria:

* None
Accu-Chek Combo in Young Patients

This is an open, prospective, descriptive study aiming to evaluate the change in treatment satisfaction of primary care givers of young children who use the Accu-Chek Combo System. Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes related therapeutic information will be collected and data about the use of the device components will be downloaded from the Accu-Chek Combo System


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus type 1
* Continuous Subcutaneous Insulin Infusion(CSII)therapy(for at least 6 months)
* Age below 6 years
* Planned and scheduled change to a Accu-Chek Combo System within the next 3 weeks at least
* Signing on an Inform Consent Form

Exclusion Criteria:

* Patient has been diagnosed with progressive/serious diseases that in judgment of the physician preclude successful completion of the observational period
* primary care giver not skilled enough to comment in a qualitative way
Efficacy of Proton Pump Inhibitor for Chronic Cough Caused by Gastroesophageal Reflux; Double-blind, Placebo-controlled, Randomized Clinical Trial

Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux; double-blind, placebo-controlled, randomized clinical trial


Eligibility Criteria:
Inclusion Criteria:

ages of 18 and 70 years had chronic cough of \>8 weeks in duration

Exclusion Criteria:

1. abnormal chest X ray, PNS view 2. previous surgical or endoscopic antireﬂux procedure 3. previous aerodigestive malignancy or Barrett's oesophagus 4. current smokers or ex-smok-ers (deﬁned as those who quit smoking \<3 months prior to study enrolment or those who have quit, but have a 20 pack year smoking history) 5. Malignancy History (lung cancer, esophageal cancer etc.) 6. upper respiratory infection within 8 weeks of study enrolment 7. currently using a PPI, H2 blocker, beta-blocker, angiotensin-converting enzyme inhibitor, corticosteroid, methylxanthine, inhaled beta-agonist, anti-inﬂammatory agent or anticholinesterase drug at time of enrolment
Cellular Immunotherapy for Relapsed or Refractory Lymphoma Data Collection

This study aims to collect clinical data from adult patients with relapsed or refractory non-Hodgkin's lymphoma (r/r NHL) receiving cellular immunotherapy to establish a large database of cellular immunotherapy for Chinese patients.

This study aims to collect efficacy and safety data from adult patients with r/r NHL who received cellular immunotherapy between January 2017 and December 2040. Study investigators will determine the most appropriate diagnostic and treatment plans for patients based on clinical practice, without any intervention due to the existence of this study. No grouping will be conducted, and subgroup analyses will be performed based on the collected data.

Data collection process:

Clinical data will be collected from patients before cellular immunotherapy, before immune cell infusion, on the day of infusion, and at the last visit or follow-up within 24 months post-infusion. This includes collecting efficacy data, adverse events related to cellular immunotherapy, and survival data. Additionally, any new tumors, pathological findings, and other relevant laboratory or auxiliary examination data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a confirmed diagnosis of r/r B-NHL (including r/r DLBCL, r/r FL, r/r MCL, HGBL-NOS, FL3b, r/r MZL, transformed lymphomas such as MCL) and r/r T-cell lymphoma, who have received informed consent waivers;
* Patients who have received or are receiving cellular immunotherapy, with cellular immunotherapy products including the following categories: cytokine-induced killer cell therapy (CIK), tumor-infiltrating lymphocytes (TIL), cytokine-induced killer cell-dendritic cell mixed therapy (DC-CIK), chimeric antigen receptor T cells, NK cells or macrophage therapy (CAR-T, CAR-NK, CAR-M), T-cell receptor chimeric T cell therapy (TCR-T), dendritic cell therapy.

Exclusion Criteria:

* NA
Parkinson and the Males Body Composition

The main aim of the present study was to ascertain the type of relationship (dependency or independency) among some of the cardinal motor symptoms of the Parkinson´s disease (PD) and the body composition (BC) variables of a group of the male PD´s patients, using the bioelectrical impedance analysis.


Eligibility Criteria:
Inclusion Criteria:

(I) Males with diagnosis of idiopathic PD and rated 1-3 on the Hoehn and Yahr Scale.

(II) No type of dementia as assessed by the mini-mental state examination. (III) Between 50 and 69 years old (a specific range of ages of the illness´s onset).

(IV) Between one and five years diagnosed with the illness. (V) Able to stand for two min without assistance. (VI) Able to walk teen m without assistance.

Exclusion Criteria:

(I) Do not meet the eligibility criteria. (II) Suffer a neurological disease other than Parkinson´s disease.
A Study of LY3214996 in Healthy Participants

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.


Eligibility Criteria:
Inclusion Criteria:

* Overtly health males
* Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Females
* Male participants sexually active with a pregnant partner
* Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study
* Have participated in a radiolabeled drug study within the previous 4 months
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Have a history of Gilbert's syndrome
* Have history or presence of psychiatric disorders
* Show evidence of human immunodeficiency virus (HIV) infection
* Show evidence of hepatitis C
* Show evidence of hepatitis B
Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD

The purpose of this randomized study is to compare ESD procedural time and cost facilitated with a dual balloon accessory device versus ESD procedures performed without the accessory device. Study is designed to detect if the double balloon interventional platform helps to perform removal of benign complex colonic lesions safer and in more efficient way.

This is a prospective, post-market, randomized clinical trial comparing colonic ESD procedures utilizing the DiLumen™ Endolumenal Interventional Platform to colonic ESD procedures that are performed without use the DiLumen™ device.

The study participants will be randomly assigned to study group and control group The treatment group will consist of up to 100 subjects treated with the DiLumen™ device. The control group will consist of up to 100 subjects treated without DiLumen™ device. Assessments will include procedure timepoints, anesthesia use, polyp location and classification, over-all cost assessment, and general complications.

The primary outcome will be analyzed using parametric statistics to compare the means of the study and control groups. P-values and confidence intervals will be reported. Descriptive and summary statistics will also be employed. Secondary outcomes will be summarized with descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women 18-85 years of age.
2. Have ability to understand the requirements of the study and provide written informed consent
3. Suspected complex adenomatous polyps in the large intestine defined as sessile or polypoid lesions 2 cm and larger in size.
4. No medical contraindication to endoscopic submucosal dissection (ESD).

Exclusion Criteria:

1. Contraindication to colonoscopy, such as active colitis, diverticulitis, perforation, or stricture.
2. History of open or laparoscopic colorectal surgery.
3. History of Inflammatory Bowel Disease (IBD).
4. Any medical or surgical condition that would preclude the endoscopic removal of the polyp.
5. Anatomy or other factors that prohibit safe access to the large intestine such as previous radiation therapy to the affected area, known colonic strictures, extensive colonic diverticuli, etc.
6. History of AIDS, HIV, or active hepatitis.
7. History of mental illness, including psychological or neurological conditions (addiction to substances such as alcohol. e.g.) that in the investigator's opinion would pre-empt their ability or willingness to participate in the study.
8. Patients who are pregnant or lactating.
9. Currently involved in another investigational product for similar purposes.