cyrilzakka/clinical-trials huggingface dataset:
Immune Registry for Organ Transplantation From COVID Positive Donors.

The purpose of this study is to collect data generated by standard clinical practice to determine the short term and long term clinical outcomes of recipients of solid organ transplantation from COVID-19 infected donors and compare it to recipients with organ transplant from COVID-19 negative donors.

To advance science, it is helpful for researchers to share information. They do this by putting data or biospecimens into one or more scientific databases (called registries or repositories), where it is stored along with information from other studies. Researchers can then study the information in other ways and combine information from many studies to learn even more. The researchers are asking for permission to store and share personal information in a research registry to help research studies in the future. The information will be available for any research question, such as research to understand what causes certain diseases in patients with solid organ transplant, development of new scientific methods, or the study of where different groups of people may have come from.

Information from participant's medical chart will be securely stored in the VCU database. This will include donor information (including COVID test results, radiologic findings, symptoms, treatments, cause of death etc.) as well as recipient information (including demographics, labs, biopsy findings if any, length of hospital stay, COVID transmission, graft function, immunosuppression, post-transplant complications and long term clinical outcomes like patient and graft survival, etc.). Data will be collected during routine clinical care.

The study will include the following tests:

* Pre transplant COVID-19 PCR on the nasal swab (as standard transplant protocol), serum COVID-19 specific T-cell immune response, and serum COVID-19 spike antibody as a study protocol in all the recipients.
* Posttransplant COVID-19 spike antibody in the serum around 4 weeks after the completion of induction Thymoglobulin as a study protocol in all the recipients.
* Daily COVID-19 PCR in serum from post-operative day 1 till post-operative day 4 as a study protocol in the recipients with organ transplant from COVID-19 positive donors.
* Posttransplant COVID-19 PCR nasal swab once around one-week post-transplant as study protocol in the recipients with organ transplant from COVID-19 positive donors.
* COVID-19 T-cell specific immune response will be checked in the recipient's serum at 4 weeks post-transplant as study protocol in all the recipients.
* According to the standard transplant protocol post-transplant donor-specific antibodies will be checked around 2 weeks post transplant and the results will direct the donor-derived cell-free DNA testing in all the recipients.

Eligibility Criteria:
Inclusion Criteria:

- Adult (\>18 years old) male and female solid organ transplant recipients

Exclusion Criteria:

* Absence of informed consent for the clinical protocol and the registry.
* Prisoners will be excluded from the study.
Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort

Due to better treatment options and earlier detection, survival rates of patients with breast cancer continue to increase. As such, (late) treatment toxicity, (long-term) quality of life and the cosmetic outcome are becoming more important. Also, many competing experimental interventions (e.g. treatment, lifestyle interventions) for breast cancer are being developed, all in need to be properly evaluated before being implemented in routine clinical care. Randomized Controlled Trials are the gold standard to do so, but they have shown many challenges, especially when applied in a cancer setting. The 'cohort multiple Randomized Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized evaluations of experimental interventions, with potential for increased recruitment, comparability and long-term outcomes as a standard.

By setting up UMBRELLA, as a prospective cohort according to the cmRCT design, the investigators aim to:

* provide an infrastructure for efficient, fast and pragmatic evaluation and implementation of experimental interventions
* gain insight into short and long-term treatment response, toxicity, complications, quality of life and survival of patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with breast cancer who undergo irradiation in the UMC Utrecht
* Informed consent - at least - for use of routinely collected clinical data and to fill out questionnaires.

Exclusion Criteria:

* Inability to understand the Dutch language
Different Susceptibility to SARS CoV-2 Infection Among Health Care Workers Highly Exposed to COVID-19.

The primary objective of this study is to establish differences in susceptibility to SARS CoV-2 infection among health care workers (HCW) highly exposed to patients with COVID-19 diagnosis. To ascertain this issue, we evaluated:

* Changes in receptor polymorphism (ACE2 and CD26 receptor study.
* SARS-CoV-2 CD4/CD8 T cell response (CTL)
* Different KIR phenotypes

Only 24% of health care workers (HCW) had developed inmunological response to SARS CoV-2 infection in one centre attending thousands of COVID-19 patients, and with shorteness of personal protective equipments. Our hypothesis is that this relatively low number of infected HCW could be secondary to:

1. Differences in susceptibility to infection mediated by changes in viral receptors. Thus, it is important to characterize and genotyping the main receptor for SARS-CoV-2, ACE2, and other related receptor, such as CD26.
2. Increased cellular immune response, offering cross-immunity against SARS CoV-2 infection by previous exposure to other coronavirus or respiratory pathogens. A specific CD4/CD8 T cell response to viral peptides could respond this question
3. Specific KIR phenotypes (Killer Immunoglobulin-like Receptors): Natural killer cells (NK) response to alterations of class I HLA molecules presented in infected cells. An increase in class I HLA expression could lead to an increase in NK activation by increasing its ability to produce IFN-gamma.

Eligibility Criteria:
Inclusion criteria

* HCW older than 18 years
* Highly exposed to COVID-19 according to the definition
* Negative (cases) or positive (controls) serology against SARS-CoV-2 infection Exclusion criteria
* Presence of any disease / treatment which could alter the susceptibility (corticoid therapy, chemotherapy, monoclonal antibodies)
* Pregnancy

High exposure definition: direct and continued care of COVID-19 diagnosed patients for 2 weeks or more, without aerosol- generating procedures, with inappropriate personal protective equipment (PPE), or unprotected exposure to patients with COVID-19 during aerosol-generating procedures.

The definition of appropriate PPE was based on previous recommendations. The absence of any part of the PPE constituted an unprotected exposure. We defined the following as aerosol-generating procedures: airway suction, application of a high-flow O2 instrument, bronchoscopy, endotracheal intubation, tracheostomy, nebulizer treatment, sputum induction, positive pressure ventilation, manual ventilation and cardiopulmonary resuscitation.
Carbendazim in Treating Patients With Advanced Solid Tumors or Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of carbendazim in treating patients who have advanced solid tumors or lymphoma.

OBJECTIVES: I. Determine the maximum tolerated dose of carbendazim in patients with advanced solid tumors or lymphoma. II. Determine the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the recommended phase II dose of this drug. V. Determine any antitumor effects of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral carbendazim 2-3 times daily 5 days a week for 3-4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carbendazim until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 30 days.

PROJECTED ACCRUAL: Approximately 30-60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor for which no standard therapy exists or which has progressed or recurred after prior therapy OR Lymphoma for which no further therapeutic options exist No hematological malignancies (e.g., leukemia) No known brain or leptomeningeal disease unless previously treated with radiotherapy, not currently treated with corticosteroid therapy, and no clinical symptoms present

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if due to tumor involvement) Alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 2 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No unstable atrial or ventricular arrhythmias that require control by medication No ischemic event within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Abnormalities that would affect absorption of study drug allowed at investigator's discretion No other severe disease or psychiatric disorder that would preclude study No phenylketonuria No known hypersensitivity reaction to artificial sweetener aspartame (e.g., Nutrasweet)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from prior chemotherapy for cancer No other concurrent cytotoxic therapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Recovered from prior radiotherapy for cancer Surgery: Recovered from prior surgery for cancer Prior gastrointestinal surgery allowed
Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. During this process, accurate measurement of transpulmonary pressure (PL) is essential to ensure the safety and efficacy of ventilation. PL is defined as the difference between alveolar pressure (Palv) and pleural pressure (Ppl). While the direct measurement of Ppl is possible, it poses a risk to tissue integrity. Thus, the primary surrogate for Ppl measurement today is esophageal pressure (Pes).

However, the measurement of Pes is not without challenges. This abstract outlines the pitfalls associated with Pes measurement, emphasizing the importance of employing well-defined procedures to mitigate potential errors. These errors can range from underestimation of Pes due to underfilled catheters to overestimation resulting from overfilled catheters.

To address these challenges and optimize Pes measurement, various methods have been proposed for titrating the filling volume of the esophageal catheter. In this study, investigators aim to assess a faster decremental filling method and compare it to the traditionally accepted Mojoli method in the context of pediatric patients. This research seeks to enhance the intensivists' understanding of the most efficient and accurate approach to Pes measurement during mechanical ventilation in the pediatric population, ultimately contributing to improved patient care and outcomes


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients between 1 months and 18 years
* Patients need mechanical ventilation support without modification of ventilation settings within the upcoming 2 hours
* Informed consent was signed by next of kin
* Requiring esophageal catheter application

Exclusion Criteria:

* Patients eligible for extubation or modification of ventilation settings within the upcoming 2 hours
* Patient included in another interventional study in the last 30 days
* Patients unable to undergo esophageal catheter insertion due to congenital or acquired pathologies
* Patient included in another interventional research study under consent
* Patient already enrolled in the present study in a previous episode of acute respiratory failure
A Decision Aid for Patients With Age-related Cataract

To determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.

The need for cataract surgery is on the rise globally due to the aging population and high demands for greater visual functioning. Patients with age-related cataract face their initial decision about when to undergo cataract surgery. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The purpose of this study is to determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 50-80 years who have been resident in the selected study district for more than six months;
2. A definite diagnosis of age-related cataract;
3. Having not received cataract surgery;
4. Willing to participate in the study and provide informed content.

Exclusion criteria

1. Bilateral blindness (presenting distance visual acuity worse than 3/60);
2. Having ocular, hearing or mental disorder precluding reading or telephone interview;
3. Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
4. Having cataract surgery contraindication.
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML

This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS).

The study consists of 2 parts:

* Part 1: Dose Escalation (DE) in both monotherapy and in combination.
* Part 2: Dose Optimization


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.

Exclusion Criteria:

* Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1.
* Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency).
* Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for \>72 hours prior to treatment
* WBC count \>25 × 10\^9/L measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).
* Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.
Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Female or male aged ≥ 18 and ≤ 65 years
* Diagnosis of Crohn's Disease

Exclusion Criteria:

* Having ileostomy or pouch and/or colostomy
* Having previous gastric surgery
* Having a known or suspected systemic infection
Using Videos in Advance Care Planning for Patients With Advanced Cancer

To compare the decision making of subjects with advanced cancer having a verbal advance care planning discussion compared to subjects using a video.

A.1. Aim 1: To recruit 150 subjects with advanced cancer and randomly assign these subjects to one of two advance care planning (ACP) modalities: 1. a video visually depicting CPR (intervention) or 2. a verbal narrative describing the CPR.

Hypothesis 1: It is feasible to recruit and randomize 150 subjects with advanced cancer.

A.2. Aim 2: To compare the care preferences for CPR among 150 subjects randomized to video vs. verbal narrative intervention.

Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt NOT to have CPR compared to those randomized to the verbal narrative.

A.3. Aim 3: To compare knowledge assessment of CPR for 150 subjects randomized to video vs. verbal narrative intervention.

Hypothesis 3: When compared to subjects randomized to the verbal narrative arm, subjects in the video group will have higher knowledge assessment scores when asked questions regarding their understanding of CPR.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of cancer that falls under one of the following: A. All patients with brain cancer, inoperable hepatocellular/bile duct/gallbladder cancer, incurable non-small cell lung carcinoma (wet IIIb or IV), extensive stage small cell lung cancer, inoperable mesothelioma, inoperable pancreatic cancer or; metastatic gastric or esophageal cancer, metastatic melanoma, OR B. Patients with the following cancers, if first-line therapy has failed and limited response is expected to second-line therapy: breast cancer, colorectal cancer, head and neck cancer, leukemia, ovarian cancer, prostate cancer, renal cancer, sarcoma, lung cancer, myeloma, or lymphoma, OR C. Less than one year prognosis.
2. ability to provide informed consent,
3. cognitive ability to participate in the study
4. ability to communicate in English.

Exclusion Criteria:

1. inability to make decisions,
2. non-English speaking,
3. new patient visit
A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors.

The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase in patients with non-small cell lung cancer who will be treated at the RP2D.

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase and the Dose Confirmation Phase.

Enrollment for dose escalation and dose confirmation is complete.

Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically or cytologically confirmed metastatic or locally advanced, squamous or non-squamous NSCLC (NSCLC). Patients must have received no more than four prior lines of therapy, including a PD-1 / PD-L1-containing therapy and a platinum containing regimen. Patients must have received no more than one taxane containing regimen and no more than one investigational agent;
2. Must provide study-related tumor specimens;
3. ECOG(PS) 0-1;
4. Estimated Life Expectancy \> 3 months;
5. Adequate bone marrow (BM), renal, hepatic and metabolic function.

Key Exclusion Criteria:

1. Concurrent cancer treatment with cytoreductive therapy, radiotherapy, cytokine therapy, cytotoxic agents, targeted small molecule therapy or any investigational anticancer small molecule drugs within 2 weeks prior to the start of study treatment (except 5 weeks from last dose of nitrosourea compound) OR treatment with monoclonal antibodies within 4 weeks prior to the start of study treatment;
2. Known symptomatic central nervous system (CNS) metastases requiring steroids.
3. Diagnosis of any other malignancy within 2 years prior to enrollment;
4. Vaccination within 4 weeks of the first dose of study treatment is prohibited except for administration of inactivated vaccines;
5. Current use of immunosuppressive medication at study entry;
6. Active or prior autoimmune disease that might deteriorate with receiving an immunostimulatory agent;
7. Acute or chronic infections requiring systemic therapy;
8. Known history of autoimmune colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis;
9. Known intolerance to checkpoint inhibitor therapy, defined by the occurrence of an AE leading to drug discontinuation;
10. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.