cyrilzakka/clinical-trials huggingface dataset:
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

This phase II trial is studying how well bortezomib works in treating patients with metastatic thyroid cancer that did not respond to radioactive iodine therapy. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

PRIMARY OBJECTIVE:

I. Determine the efficacy of bortezomib, in terms of tumor response rate, in patients with metastatic papillary or follicular thyroid cancer unresponsive to prior radioiodine therapy.

SECONDARY OBJECTIVE:

I. Determine the clinical activity of this drug, in terms of progression-free survival, in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Eligibility Criteria:
Inclusion Criteria:

* The Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100%
* Platelet count \>= 100,000/mm\^3
* Absolute neutrophil count \>= 1,500/mm\^3
* White Blood Count (WBC) \>= 3,000/mm\^3
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =\< 2.5 times upper limit of normal
* Bilirubin normal
* No symptomatic congestive heart failure
* Creatinine normal OR creatinine clearance \>= 60 mL/min
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* At least 4 weeks since prior chemotherapy
* No more than 2 prior chemotherapy regimens
* At least 6 months since prior external beam radiotherapy for locoregional disease in the thyroid bed or to the cervical or upper mediastinal lymph nodes (dose =\< 6,000 cGy)
* At least 6 months since prior radioiodine therapy
* No prior external radiotherapy to the measured tumor
* Prior thyroidectomy allowed
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* Unresponsive to prior radioiodine therapy
* Histologically confirmed differentiated thyroid cancer-papillary or follicular type, including, but not limited to, any of the following variants: hurthle cell (oxyphilic), insular, columnar cell, tall cell
* Metastatic disease
* At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
* No prior radiotherapy to the only measurable lesion
* No radioiodine uptake in the measured metastatic tumor by radioiodine scan (Note: Must have had \>= 1 radioiodine scan since the last radioiodine treatment)
* No known brain metastases
Anesthetic Depth Effects Upon Immune Competent Cells

Anesthesia depth affects the proliferation of lymphocytes to NK-cells and memory T-cells effect and the phagocytosis activity of macrophages in healthy patients. ASA 1-3 subjects undergoing extended shoulder surgery under continuous regional anesthesia randomly were assigned to a deep or a shallow anesthesia level (BIS \<35 or \>55) for more than an hour. Immune response is measured by lymphocyte proliferation as well as neutrophil and monocyte phagocytosis activity.

Blood samples were taken under minimal stress prior to anesthesia induction (T0), recovery (T1) and 12 weeks following hospital discharge (T2) from the respective anesthesia depth level. Bispectral index monitoring (BIS) was performed from the awake state to complete recovery in all subjects.

Hemoglobin concentration, leukocyte and lymphocyte counts were determined by routine automated laboratory techniques. Lymphocyte proliferation was analyzed by SASPA flow cytometry analysis. In brief, 100 µl EDTA blood were stirred with 10 µl FITC and PE marked antibody mixture containing CD3, CD4, CD8, CD 16, CD45, CD28, CD27, CD 56.

Monocyte and neutrophil phagocytosis activity was measured separately in macrophages of fresh heparinized whole blood using flow cytometric test kits.

Proteomics of monocytes was done synchronously.

Eligibility Criteria:
Inclusion Criteria:

* enrolment for longer shoulder surgery
* consent for the standard anesthesia form in combination with the interscalene plexus block
* ASA Status 1-3

Exclusion Criteria:

* sedative premedication
* severe immune deficiency (diabetes, steroid or antihistamine medication, cancer, chemotherapy,
* status post transplantation, drug and alcohol abuse),
* recent surgery (1 month) or blood transfusion
Role of Hematological Parameters in the Stratification of COVID-19 Disease Severity

The hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.

Objective:

COVID-19 virus involves respiratory as well as other body systems including cardiovascular, gastrointestinal, neurological, immunological and hematopoietic system. Patient of covid-19 pneumonia presents with wide range of hemostatic abnormalities. These hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.

Material and Method:

This was a retrospective study, conducted in Department of Pathology and Department of medicine, FMH college of Medicine and Dentistry from May 2020 to July 2020. Total of 101, confirmed cases of covid-19 disease, both genders between 17 to 75-year age were included. Hematological parameters were compared in mild, moderate, severe and critical disease group. Continuous variables were analyzed by using non parametric, Kruskal Wallis test while categorical variables were analyzed by chi-square test.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed cases of covid-19 disease
* Both genders
* 17 to 75 year age

Exclusion Criteria:

* known case of chronic liver disease
* known hematological diseases were excluded
Population Pharmacokinetics of Dexmedetomidine in ICU Patients

Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist registered for sedation of patients in intensive care units. Although the pharmacokinetics of dexmedetomidine have been studied previously also in an ICU setting, there is no information on the pharmacokinetics of long-lasting (\>48 hours) dexmedetomidine infusions in humans.

The aim of this study is to study the pharmacokinetics of long-lasting dexmedetomidine infusions in ICU patients using the population pharmacokinetics approach.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Need for dexmedetomidine sedation (determined by the responsible physician).
* Predicted length of dexmedetomidine sedation ≥ 48 hours.
* Written informed consent from the patient or the relatives of the participating patient.

Exclusion Criteria:

* A previous history of intolerance to the study drug or related compounds and additives.
* Existing significant haematological, endocrine, metabolic or gastrointestinal disease
Diving for Post Traumatic Stress Disorder (PTSD)

within the components of Scuba diving there are similarities with meditation and mindfulness techniques. PTSD and emotion dysregulation are known to be involved by meditation training This study evaluates the benefits of scuba diving on quality of life and mindful functioning comparing the benefits of diving training using a clinical trial protocol


Eligibility Criteria:
Inclusion Criteria:

* ptsd

Exclusion Criteria:

* mindfulness practice
Evaluating Serum Sestrin in Leiomyoma Patients

Leiomyomas are the most common benign neoplasms of women's reproductive system affecting 20-30% of women within the reproductive ages. Sestrins are serum proteins which are highly expressed under circumstances of DNA damage, hypoxia and oxditive stress and play an important role in autophagia. The aim of this study is to evaluate the relationship of serum sestrin proteins with development of leiomyomas.

Leiomyomas are the benign neoplasms of uterus and the role of genetics, estrogen levels and obesity has already been shown in their development. Higher levels of serum sestrin proteins have already been associated with DNA damage, hypoxia and oxidative stress and sestrin plays an important role in autophagia. In order to evaluate the role of serum sestrin in the development of leiomyomas 30 patients between 18-45 years of age who were diagnosed with uterine leiomyomas with transvaginal ultrasonography will be included in the study group. Their serum sestrin levels will be determined and compared with that of 30 healthy subjects recruited during the same study period at the same clinic.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age
* patients diagnosed with uterine leiomyomas will be included in the study group
* patients without any additional comorbidities
* patients without any autoimmune diseases

Exclusion Criteria:

* patients with systemic diseases
* patients with known chronic inflammatory diseases
* patients using hormonal and/or medical therapy
* pregnant women
* lactating women
* patients with malignant diseases
Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects

The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced by vitamin K antagonists in Japanese subjects who require immediate correction of international normalized ratio (INR) due to a major bleed or emergency surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male and female Japanese subjects greater than or equal to 20 years
* Subjects currently on vitamin K antagonist (VKA) therapy
* INR greater than or equal to 2 within 3 hours before start of BE1116 infusion
* Urgent reversal of VKA therapy for a surgical or invasive medical procedure is required within 24 hours of the start of BE1116 infusion, or presentation with an acute major bleed

Exclusion Criteria:

* Subjects for whom administration of I.V. vitamin K and VKA withdrawal, alone, can adequately correct the subject's coagulopathy before the infusion of BE1116
* Subjects in whom lowering the INR to within the normal range is not a treatment goal
* Use of anticoagulants other than VKAs (or expected use within 1 day)
* Medical history for which PCCs are contraindicated
* History of thromboembolic event within 3 months of screening
* Congenital or acquired abnormality of hemostasis other than receipt of VKAs
* Administration of whole blood, plasma, plasma fractions, or platelets within 2 weeks prior to the start of BE1116 infusion
* For subjects with intracranial hemorrhage (ICH):

  * Glasgow Coma Score (GCS) \< 7
  * Intracerebral hematoma volume \> 30 cm3 as assessed by computed tomography (CT) scan
  * For subdural hematomas: maximum thickness ≥ 10 mm, midline shift ≥ 5 mm, or acute subdural hematomas (based on neurosurgeon review)
  * For subarachnoid hemorrhage: any evidence of hydrocephalus, or Hunt and Hess Scale \> 2, or concomitant subdural hematoma
  * Infratentorial ICH location
  * Epidural hematomas
  * Intraventricular rupture of hemorrhage
  * Requires surgical intervention
COVID-19 and Lung Ultrasound Utility

Ultrasounds are usually done by a specially trained health professional in the hospital or emergency department (ED) setting. Using a novel single-probe device, the ultrasound can be plugged into an iOS / Android device. The purpose of this research is to assess the usefulness of lung ultrasound imaging, performed by the patient in the home setting for the management of the COVID-19 disease using this novel highly-portable ultrasound.

This will be a prospective self-controlled design. The study subjects will receive a telehealth visit from a healthcare provider (HCP) to assess for any change in their COVID-19 symptoms. The HCP will recommend the patient remain at home, or to go to an emergency department based on standard of care and clinical decision making. Subsequently, the study subjects will receive a teleguidance session with a Radiologist who is trained in lung ultrasound (LUS) in order to obtain images of their chest. The physician performing LUS remotely will report LUS findings in a standard quality assurance (QA) document, including image quality, interpretation, and recommendations. This QA report will be study data and not shared with the patient. The two providers will be blinded, except when there is a disagreement between the Telemed LUS and clinical interview.

The study staff will determine when this disagreement occurs. They will notify the study investigators and radiologist, who will then discuss and come to an agreement within 24 hours. If deemed concerning, they will then contact the HCP and unblind them as to the radiographic findings. There will be no delay in medical care advised by the subject's HCP.

Specifically, the nurse will inform the HCP by a phone call that the physician performing LUS remotely found a significant change in LUS findings. The HCP will then be given access to the LUS report (as well as images if desired), and will review the decision to seek medical care with the telemed doctor.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older and able to provide a valid informed consent.
* Must have a nasal swab positive RT-PCR for COVID-19
* Must have access to Wi-Fi at home

Exclusion Criteria:

* Subjects unwilling or unable to directly provide consent.
* The following vulnerable study subject populations will not be eligible: prisoners, mentally impaired, or disadvantaged groups.
* Any condition deemed by the principal investigator, in his or her judgment, that may impact the subject's ability to meet the requirements necessary to collect the exam data required.
Relationship Between Aortic Parietal Inflammation on 18F-FDG PET Scan and Arterial Stiffness as a Function of Age

Show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.

In the literature, a relationship has been demonstrated between local inflammation in the aortic wall and increased arterial stiffness. Arterial stiffness is commonly represented by pulse wave velocity (PWV) measured using an applanation tonometer. It would seem that this parietal inflammation precedes arterial stiffness and consequently, arterial hypertension . Arterial stiffness is an important factor of cardiovascular morbidity and mortality and therefore represents a major public health interest in prevention in the face of the continuous aging of our population . This study will consist in studying on a population divided into three age groups, less than 40 years old, 40 to 60 years old and more than 60 years old, the relationship between thoracic aortic parietal inflammation evaluated using the Standard Uptake Value parameters (SUV) and Hounsfield units (HU) measured on 18F-FDG PET/CT scans performed between 09/04/2018 and 11/06/2020 and arterial stiffness parameters. We will seek to show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent whole-body 18F-FDG PET/CT included in the PACTEP study
* Patient with an assessment of arterial stiffness by applanation tonometer

Exclusion Criteria:

* patients without an assessment of arterial stiffness by applanation tonometer
Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy

Is real-time myocardial perfusion echocardiography (RTMPE) a feasible and effective non-invasive method to detect significant Coronary Allograft Vasculopathy in pediatric and adult cardiac transplant recipients? Will perfusion deficits correlate with significant coronary artery stenosis identified by standard stress echocardiography and Invasive Coronary Angiography (ICA), and identify diffuse small vessel disease more effectively than current non-invasive techniques?

Heart transplant recipients are susceptible to developing a unique disease that causes blockages in the arteries of the transplanted heart (coronary arteries) called Coronary Allograft Vasculopathy (CAV). Because CAV often progresses without symptoms, transplant recipients undergo regular surveillance testing so that CAV can be detected and treatment can be offered before significant damage to the transplanted heart occurs. Current tests used to detect CAV are either invasive (with risk of complications) or may not be able to detect CAV in its early stages. Myocardial contrast perfusion echocardiography is a safe non-invasive diagnostic test that may be well suited for detecting CAV, however has not been well studied in heart transplant recipients. This study examines the ability of myocardial contrast perfusion echocardiography to detect CAV in adult and pediatric heart transplant recipients, and compare those results to current standard testing strategies such as Invasive Coronary Angiography (ICA) and standard stress echocardiography. This will help determine whether myocardial contrast perfusion echocardiography is a better test for regular surveillance of CAV in adult and pediatric transplant recipients.

Eligibility Criteria:
Inclusion:

* Cardiac transplant recipients (\> or equal to 10 months post transplant)
* Clinically followed at Mayo Clinic, Rochester Minnesota

Exclusion:

* Standard contraindications to the use of ultrasound contrast and pharmacologic stress
* Recent (\< 3 months) hospitalization for heart failure, acute coronary syndrome or allograft rejection
* Multi-organ transplant Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
* Hypersensitivity to perflutren
Microarray Analysis of Gene Expression in Liver Tumors

This study aims to study the gene expression profiles of liver tumors to help us understand their biology, and to find new tumor and treatment markers for liver cancer.

The purpose of this research is to study of the biologic features of liver tissue (by studying their gene expression profiles), so that we can increase our understanding of the processes involved in liver cancer development and growth. This may allow us to identify more effective ways of diagnosing, treating, and predicting the outcome of patients with liver cancer.

Eligibility Criteria:
Inclusion Criteria:Inclusion Criteria:

* Patients with liver tumors undergoing partial liver resection, open liver biopsy, and patients undergoing liver transplantation with or without liver tumors at Stanford University
* Patients older than 18
Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who Have Sex With Men (MSM)

The study will evaluate the use and effectiveness of mobile-messaging platforms as a public health strategy for improving sexual health outcome measures among men who have sex with men (MSM) by determining whether exposure to the message-delivery platform results in improvements in participants' self-reported sexual health and prevention behaviors, beliefs and attitudes. The study will enroll men into a randomized controlled trial. Participants randomized to the messaging intervention will have access to a smartphone-based messaging platform for three months while those assigned to the waitlist group will be offered access to the messaging platform after all follow up is complete. Participants will complete surveys at baseline, after the end of the 3 month intervention, and follow up surveys 6 and 9 months after the baseline survey.

This study aims to evaluate the use and effectiveness of a smartphone-based messaging platform as a public health strategy for improving participants' self-reported sexual health and prevention behaviors, beliefs and attitudes. The study will enroll 1,206 men into a randomized controlled trial. They will be assigned to either the immediate intervention group ("intervention arm") or the waitlist-control group ("waitlist-control arm"). All participants will take an assessment survey at baseline, and the intervention group will be oriented on the installation and use of the messaging app upon randomization to that group. All men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 9-month follow-up period. When the intervention arm activities and assessments have concluded, participants in the waitlist-control arm will then be given the option of accessing to the intervention app and participation in intervention post-test activities.

Eligibility Criteria:
Inclusion Criteria:

* Assigned male at birth
* Current, self-reported gender identity as "Male"
* Aged 18 or over
* Self-reported ability to read and understand English-language
* Resides in the Atlanta, Georgia (GA), New York, New York (NY), or Detroit, Michigan (MI) Metropolitan Statistical Area.
* Self-reported anal sex with a male partner in the past 12 months
* Owns and uses an Android or Apple (iOS) smartphone
* Is included in one of the following risk groups, by self-report:

  * HIV seropositive
  * HIV seronegative at "higher risk" (condomless anal sex and not taking PrEP as prescribed in the past 3 months)
  * HIV seronegative at "lower risk" (no condomless anal sex in the past 3 months, or condomless and sex while taking PrEP as prescribed in the past 3 months)

Exclusion Criteria:

* Currently participating in another HIV prevention research study or program
* Participant's phone or device does not support HealthMindr application
* Tested positive for HIV for the first time in the past 6 months
* Has a plan to move out of the Atlanta, GA, New York, NY or Detroit, MI, Metropolitan Statistical Area within in the next 9 months
Comparison of Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy

A prospective, randomized clinical trial comparing blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).

Orthotopic liver transplantation (OLT) can be associated with significant bleeding requiring multiple blood product transfusions, especially in patients with severe liver dysfunction. Rotational thromboelastometry (ROTEM) is a point-of-care device that has been used successfully to monitor coagulation on whole blood samples during OLT. Whether it allows blood loss and transfusion to be reduced during OLT remains controversial. ROTEM or conventional coagulation tests were used in this study to guide transfusion of platelets, cryoprecipitate, and fresh frozen plasma (FFP) during OLT. Patient characteristics as well as pre- and post- transplant laboratory data were collected. Intra-operative blood loss, type and amount of blood products transfused, and cost were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 and older, admitted to the hospital
* Patients who have clinically documented cirrhosis
* Patients who are coagulopathic (INR \> 1.5 and/or platelets \< 50,000)
* Patients undergoing an endoscopic procedure or neurosurgical procedure

Exclusion Criteria:

* Patients must not be pregnant
* Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis)
* Patients must not have an active infection (per PI discretion)
* Patients must not have any known hemostatic disorder