cyrilzakka/clinical-trials huggingface dataset:
Outreach Core Activities

The Ponce Health Sciences University-Moffitt Cancer Center (PSHU-MCC) U54 Outreach Core (OC) goal is to increase community cancer awareness, community engagement (CE) and participation in cancer health disparities research and outreach in Hispanic/Latino communities through the following:

Aim 1: To develop, deliver, and disseminate cancer education and outreach activities to Hispanic/Latino community members to reduce cancer health disparities.

Aim 2: To enhance capacity for mutually beneficial research engagement to address cancer health disparities.

Aim 3: To expand the capacity to train community members as lay health promoters to deliver evidenced-based cancer education programs in their communities.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Any health status
* Able to speak, read and write Spanish or English (some events are in Spanish, some are in English)
* \[Cancer 101 Online Training Program, Lunch and Learn podcast, and Stakeholders Program only\]: Have access to the internet
* Willing to complete the training modules and assessments \[Cancer 101 Online Training Program\]
* Willing to complete registration, attendance logs, and evaluations, as applicable
* \[Community Engagement Training Program, Research Corner only\]: be a researcher who received U54 funding in the proposed renewal period including Full, Pilot, and Developmental projects.
* \[Stakeholders in the Community-based Training Program and Cancer 101 Stakeholders program only\]: nurses, community health educators, clinical social workers, physicians, psychologists, among other healthcare professionals

Exclusion Criteria:

* Does not meet inclusion criteria
Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma

This phase I trial is studying the side effects and best dose of EMD 121974 in treating patients with solid tumors or lymphoma. Cilengitide (EMD 121974) may stop the growth of cancer cells by stopping blood flow to the cancer

PRIMARY OBJECTIVES:

I. Determine the dose-limiting toxicity, maximum feasible dose, and recommended phase II dose of cilengitide (EMD 121974) in patients with advanced solid tumors or lymphoma.

II. Determine the safety and tolerability of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics of this drug in these patients. II. Determine the antineoplastic activity of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive cilengitide (EMD 121974) IV continuously on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumor or lymphoma
* Refractory to standard therapy or no standard therapy exists
* Measurable or evaluable disease
* No active brain metastases

  * Previously treated brain metastases allowed provided the patient is not currently receiving corticosteroids
  * Primary brain neoplasms allowed, regardless of corticosteroid use
* Performance status - Karnofsky 70-100%
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No life-threatening bleeding diathesis within the past 6 months
* Bilirubin normal (unless due to Gilbert's syndrome)
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No prior proven gastric or duodenal ulcer
* No clinically significant gastrointestinal blood loss within the past 6 weeks
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior CNS hemorrhage
* No psychiatric illness or social situation that would preclude study compliance
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No prior cilengitide (EMD 121974)
* No other concurrent biologic therapy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No concurrent chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy and recovered
* No concurrent palliative radiotherapy
* No other concurrent anticancer agents or therapies intended to treat the malignancy
* No other concurrent investigational agents
* No concurrent anticoagulation therapy that increases INR or aPTT above the normal range

  * Line prophylaxis allowed
Evaluation of the Safety and Efficacy of Azvudine and Paxlovid in the Treatment of Hospitalized Patients With COVID-19

In this retrospective study, we aimed to evaluate the clinical efficacy and safety of two antiviral drugs on COVID-19 and inpatients with existing complications in the First Affiliated Hospital of Shandong First Medical University. In addition, we also explored a key issue. Is the combined treatment effect of two antiviral drugs, Paxlovid and Azvudine, better than the use of a single drug?

We conducted a single center retrospective cohort study on hospitalized patients with severe acute respiratory syndrome coronavirus type 2 infection who received treatment with nimatevir/ritonavir tablets or azivudine tablets at the First Affiliated Hospital of Shandong First Medical University from December 1，2022 to January 31，2023. In the research of this project, it is necessary to extract, sort out and retrospectively analyze the clinical data of all patients with COVID-19 who have received Nematovir/Ritonavir tablets or Azivudine tablets in the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital), and respectively identify the relevant epidemiological characteristics of COVID-19 patients, It is planned to use multiple linear regression or logical regression model to explore the relevant factors that affect the drug use efficiency index, safety index and total cost of patients with COVID-19, so as to provide scientific and quantitative evidence support for the drug use mode of the disease, the clinical value of the drug and the rational drug use of patients, and also provide favorable basis for the supervision and decision-making of smart pharmacy of medical institutions.

Eligibility Criteria:
Inclusion Criteria:

* 1. The patient's admission time is from December 1,2022 to January 31,2023. 2. The patient has used either Paxlovid or azivudine tablets during admission. 3. Age ≥ 18 years old. Exclusion Criteria：
* 1. Patients using other antiviral drugs. 2. Patients with incomplete clinical data.
The Role of Fat Emboli in the Trauma Inflammatory Response

This is an observational study designed to investigate the role of fat emboli in patients who are undergoing a tibial or femoral fracture procedure in the operating room. The purpose of this study is to obtain samples of bone marrow and blood during tibial or femoral fracture procedures to understand the inflammatory response.

Bone marrow is routinely removed during a tibial or femoral fracture procedure; researchers will take samples for this study from bone marrow that has already been removed as part of this procedure. No additional marrow samples will be taken as part of this research study. Also, researchers will collect blood (about 4 teaspoons) for testing inflammatory response and coagulation. Researchers may need to insert an additional line to collect your blood.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a tibial or femoral fracture procedure in the operating room.

Exclusion Criteria:

* n/a
Dignity Therapy+: A Brief Psychological and Existential Intervention for Dying Patients and Their Families.

Background: There has been significant progress in symptom management, pain relief and improvement of quality of life in patients nearing death by implementing palliative care programs. Existential and dignity related issues, such as loss of autonomy and sense of meaning or feeling a burden to others are frequent reasons for psychological distress and desire for hastened death. Dignity Therapy (DT), developed by Chochinov et al., is a brief, individualized psychotherapy for the purpose of relieving distress by directly addressing dignity conserving factors.

Aims: To test whether the inclusion of a patient's partner or designated family member into Dignity Therapy (DT+) could mitigate psychological distress (anxiety and depression) in both, the patient nearing the end of his life experiencing increased psychological distress and the patient's partner/family member compared to the control groups receiving Dignity Therapy in the single setting (DT) or standard palliative care (SPC).

Methods and design: In this randomized controlled trial a total of 159 patients with a diagnosis of an advanced disease and poor prognosis (life expectancy \< 6 months) who receive palliative care either in the Palliative Care Centre of the University Hospital Zurich (USZ) or the Clinic Susenberg, Zurich, or in the "Lighthouse" Hospice Zurich, will be randomly assigned to either DT+, DT, or SPC in a 1:1:1 ratio. Patients will be pre-screened and included if they report increased psychological distress (anxiety, depression using the Hospital Anxiety and Depression Scale=HADS). The therapy is guided by trained therapists and consists of 3 audiotaped sessions. The main focus of the intervention is to invite patients to reflect on their most important achievements, roles or other things in their lives or things that they would most want remembered. On completion, the audiorecording is transcribed and edited to provide a clear and readable narrative, the generativity document, which can be passed to a person of the patient's choice. DT+, in contrast to the original intervention developed by Chochinov et al., is a systemic approach in which patient's partners or designated family members are included.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Diagnosis of advanced cancer and life expectancy \< 6 months
* Receiving palliative care at the Palliative Care Centre or oncological wards at the University Hospital Zurich, the Susenberg Clinic, or Zurich 'Lighthouse' Hospice
* ≥ 18 years of age
* HADS score ≥ 8

Exclusion Criteria:

* Delirious (ICD-10: F05.9)
* Cognitively impaired
* Too ill to complete the requirements of the protocol
* Unable to speak and read German
Feasibility Trial of the Bios Device for Continuous Glucose Monitoring

The study is an open-label, prospective, within-subject comparison of the Bios device readings versus venous blood sample glucose readings, glucose readings from a Dexcom CGM and an SMBG device in subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age;
2. Subject has had a diagnosis of diabetes mellitus either Type I or Type II;
3. For insulin-using subjects only: subject will not inject insulin or wear an insulin pump insertion set within a 10 cm distance of any Bios device;
4. Subject able to wear multiple CGM devices simultaneously;
5. Subject is either a patient diagnosed with Type I diabetes mellitus currently wearing a Dexcom CGM device or a patient diagnosed with Type II diabetes mellitus who will agree to use a Dexcom CGM device during participation in the study. There are no restrictions on the model of the Dexcom CGM device.
6. Subject agrees to provide a log of medications (prescription and over-the-counter) and dietary supplements (e.g., vitamins) taken during the study period, including dosage;
7. Subject has a smart device that complies with the requirements listed in Attachment 1 of this protocol and is willing to download and run the GraphWear Patient application on their device;
8. Subject is able to read and understand the Informed Consent Form and has voluntarily provided written informed consent;
9. In the Principal Investigator's opinion, subject is able to be compliant with provisions laid out in this protocol.

Exclusion Criteria:

1. Subjects with any physical or behavioral disorder, which, in the opinion of the Principal Investigator, may interfere with the use of the device or compliance with the study protocol;
2. Subject has any of the following:

   * a skin condition that precludes wearing of the device;
   * a known allergy that precludes wearing of the device;
   * tattoos or other skin alterations that may interfere with device placement and/or operation;
3. History of substance abuse within 6 months of study start;
4. Use of any illicit drugs during the duration of the study period;
5. Marijuana use during the duration of the study period;
6. If female, subject is pregnant or nursing;
7. Subject is on active dialysis;
8. Subjects whom the Principal Investigator believes may not be an appropriate candidate for this device.
Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients

Aging is accompanied by a gradual alteration in the functional reserve of several organs and a change in body composition that can affect the pharmacokinetics, response, and safety profile of medications. Lidocaine is a local anesthetic used daily in perineural or intravenous administration to reduce the need for opioids. Although its analgesic efficacy is well-established, there is currently only one older study regarding the pharmacokinetics and pharmacokinetic-pharmacodynamic (PK-PD) relationship of lidocaine in healthy elderly patients. In this study, conducted with a small sample size (13 subjects over 64 years old and 24 young subjects under 38 years old) and using a low bolus of 25 mg, the half-life of lidocaine was increased by 59% and clearance was decreased by 35% in elderly male subjects without significant differences in females. However, the recommendations for intravenous administration of lidocaine for analgesic purposes are the same for all: a bolus of 1 to 2 mg/kg followed by continuous administration of 1.5 to 2 mg/kg/h. Morphine sparing is particularly important in elderly patients due to their increased sensitivity to adverse effects. With this study, the investigators aim to define the optimal dose to administer in elderly subjects, in order to optimize analgesia while remaining within the therapeutic range to limit the adverse effects of lidocaine.


Eligibility Criteria:
Inclusion Criteria:

CI1 - Adult participant (≤ 40 years old) and (≥ 70 years old). CI2 - Undergoing abdominal, digestive, hepatic, urological, or gynecological surgery with an expected duration \> 2 hours.

CI3 - Covered by a social security plan. CI4 - Provided with both oral and written information about the protocol and has signed informed consent to participate in this research.

Exclusion Criteria:

NC1 - Allergy to lidocaine or any of its excipients.

NC2 - Presence of comorbidities that may alter lidocaine pharmacokinetics, such as:

* Heart failure (ejection fraction \< 45%).
* Renal failure (creatinine clearance \< 15 ml/min).
* Hepatic failure (prothrombin time \< 15%).
* Body Mass Index (BMI) \> 30.

NC3 - Long-term treatment with an antiarrhythmic drug.

NC4 - Ongoing treatment with strong CYP 1A2 inhibitors (e.g., Ciprofloxacin, Fluvoxamine) and/or CYP 1A2 inducers (e.g., Carbamazepine, Modafinil, Ritonavir).

NC5 - Use of peripheral or neuraxial regional anesthesia or local anesthetic infiltration.

NC6 - Known pregnancy or ongoing breastfeeding.

NC7 - Adult under legal protection (e.g., judicial safeguard, guardianship, or tutelage) or deprived of liberty.

NC8 - Participation in another interventional study.

EXCLUSION CRITERIA

EC1 - Any eligibility criterion that is no longer met between the signing of consent and the day of surgery.

EC2 - Participant with no blood sample for pharmacokinetics
Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer

This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination with trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2) overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study consists of a dose escalation part and a dose expansion part. LJM716 will be administered intravenously once weekly unless a less frequent dosing regimen such as every 2 weeks or once every 4 weeks is introduced. Patients will continue on their trastuzumab dosing, administered intravenously once weekly at 2mg/kg. During dose escalation, a minimum of 15 patients are anticipated to be treated in successive cohorts. The dose escalation will continue until the MTD/RDE is declared. The RDE dose selected will either be the MTD or a dose below the MTD based on safety and Pharmacokinetic/Pharmacodynamic (PK/PD) considerations. Following the MTD/RDE declaration, approximately 20 MBC and 20 MGC patients will be enrolled in separate arms in the dose expansion part and treated at the MTD/RDE to further assess the safety, tolerability, and anti-tumor activity of the combination.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed HER-2 positive, metastatic or non-operable locally advanced breast or gastric cancer
* Metastatic breast cancer patients must have received a minimum of 1 and a maximum of 3 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab, ado-trastuzumab emtansine or lapatinib
* Metastatic gastric cancer patients must have received a minimum of 1 and a maximum of 2 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab or ado-trastuzumab emtansine
* During the dose expansion part of study, all patients must have at least one measurable lesion as defined by RECIST criteria.
* Patients must have at least one prior trastuzumab-containing regimen
* Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2

Exclusion Criteria:

* Patients with Central Nervous System (CNS) metastasis which are: symptomatic or require treatment for symptom control and/or growing
* Prior treatment with any anti-HER3 (Human Epidermal growth factor Receptor 3) treatment
* Impaired cardiac function
* Prior to the first dose of study treatment, patients who have received systemic antineoplastic therapy or any investigational therapy within 4 weeks or within 5 half- lives of the therapy prior to starting study treatment, whichever is shorter, or for cyclical therapy, within one cycle length (e.g. 6 weeks for nitrosourea, mitomycin-C).
* Patients who have a history of primary malignancy other than that being treated in this study, and currently requires active clinical intervention.
* Patients who do not have an archival tumor sample (or sections of it) available or readily obtainable.

Other protocol-defined inclusion/exclusion criteria may apply
Vouchers for Improving Transplant Access to Lifestyle Nutrition - Kidney Transplant

This study evaluates the effect of a six-month fruit and vegetable voucher program on satisfaction, dietary quality, and health outcomes among pediatric and young adult kidney transplant recipients experiencing food insecurity.

This is a single-arm, prospective interventional study enrolling 18 participants aged 6 to 25 years who have undergone kidney transplantation and screened positive for food insecurity within the past six months.

Participants will receive monthly fruit and vegetable vouchers for six months, distributed via Electronic Benefit Transfer (EBT) cards. The EBT cards, managed by an external partner, will be automatically reloaded monthly and be redeemable at participating retailers.

Data collection will include participant-reported satisfaction surveys post-intervention, food security and dietary quality assessments at baseline and study end, biophysical outcomes (BMI, blood pressure) from routine clinical care, laboratory markers related to kidney and nutritional health (serum potassium, phosphorus, magnesium, albumin, bicarbonate, fasting glucose or HbA1c, and creatinine/GFR), tacrolimus variability to serve as a proxy for medication adherence.

No extra clinical visits or lab draws beyond standard care are required. The findings aim to inform future strategies to address food insecurity in transplant populations.

Eligibility Criteria:
Inclusion Criteria:

* Age: Children and young adults aged 2 to 25 years who have received a kidney transplant.
* Food Insecurity: Patients who have screened positive for food insecurity (FI) within the past six months, based on the Hunger Vital Sign
* Patients who are currently receiving care at the transplant center and whose caregivers (if the patient is less than 18 years of age) are willing to participate in the intervention.
* Caregivers of non-adult patients

Exclusion Criteria:

* Patient being on a diet consisting of only total parenteral nutrition or tube feeds.
Cholesterol-lowering Effects of Lupin Protein

The objective of the study is to determine the efficacy of lupin protein drinks (Lupinus angustifolius Boregine) in humans. Parameters concerning cardiovascular risk factors and the metabolism of proteins, lipids and cholesterol will be evaluated.

Based on the preliminary finding that a daily dosage of 35 g lupin protein is capable to affect plasma lipids positively, the physiological effects of two different daily lupin protein dosages will be investigated in two separate study groups (group A: 25 g protein/day; group B: 40 g protein/day). Both study groups undergo double-blinded and controlled study conditions in a cross-over design.

In each of the two study groups 35 volunteers with hypercholesterolemia will be allocated to one of two randomization groups: After a 1-week run-in period (baseline), half of the 35 participants of each study group will consume drinks with lupin protein in the respective amount (25 g or 40 g protein/day) over a period of eight weeks, the other half will receive the analogue amount of milk protein as well incorporated in a drink serving as control. After a wash-out period of four weeks, the protein source will be crossed within the two study groups for a second intervention period of eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* Moderate hypercholesterolemia (total cholesterol \>5,2 mmol/L)
* Age: 18-80 years old

Exclusion Criteria:

* Intake of lipid-lowering pharmaceuticals
* Allergy against legumes or milk protein
* Intolerance against milk
* Pregnancy, lactation
* Chronic bowel disease
Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture

The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making palliative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. Almost all of the published data comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have favored metallic stents when compared with plastic stents in patients with distal malignant obstruction expected to live at least 3 to 6 months.

There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction.

The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient with malignant hilar obstruction

Exclusion Criteria:

* No written informed consent
* Patient with uncorrectable severe coagulopathy
* Indication for surgical operation
* Karnofsky score \< 60%