cyrilzakka/clinical-trials huggingface dataset:
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with Philadelphia chromosome-positive chronic myelogenous leukemia.

OBJECTIVES:

Primary

* Determine the activity of bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine (CMLVAX100), in terms of peripheral blood bcr-abl/abl ratio reduction, in patients with Philadelphia chromosome-positive chronic myelogenous leukemia.

Secondary

* Determine the reduction of molecular residual disease at 3 months in patients treated with this vaccine.
* Determine the reduction of molecular residual disease at 12 months in patients treated with maintenance boosts of this vaccine.
* Determine the rate of complete molecular response at any time after vaccination.
* Determine in vivo and in vitro peptide-specific immune response induced by the vaccine.

OUTLINE: This is a prospective, nonrandomized, open-label, multicenter study.

Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1 and 2 and bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine (CMLVAX100) SC on day 2. Treatment repeats every 2 weeks for 6 courses. Patients then receive CMLVAX100 SC once monthly for 3 months and then once every 3 months for 6 months (for a total of 1 year). Patients may receive additional CMLVAX100 SC every 6 months for at least 3 years. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 69 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of chronic myelogenous leukemia (CML) meeting the following criteria:

  * Philadelphia chromosome positive disease
  * b3a2 breakpoint mutation
* Prior treatment with conventional imatinib mesylate for ≥ 18 months required

  * Complete cytogenetic response documented on ≥ 2 different examinations

    * Persistence of molecularly detectable residual disease (any level of bcr-abl transcript)
  * Patients continue to receive imatinib mesylate at the same dose (conventional treatment) during study treatment

PATIENT CHARACTERISTICS:

* WHO performance status 0-1
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No severe active infection or other serious medical illness that would preclude study completion
* No known immunodeficiency
* No autoimmune disorders

PRIOR CONCURRENT THERAPY:

* No concurrent immunosuppression or systemic immunosuppressive medication
* No concurrent dose escalation of imatinib mesylate
* No other concurrent investigational products
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Atorvastatin

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of atorvastatin.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a body weight of at least 45 kg and a body mass index of 18 to 32 kg/m2, inclusive
* The subject's clinical laboratory test results at Screening and Day 1 are within normal limits unless the Investigator considers the abnormality to be "not clinically significant." Results for aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin must not be above the normal range
* Subject agrees to sexual abstinence, or is surgically sterile, or is using a medically acceptable double barrier method to prevent pregnancy during the study and for three weeks after the follow up phone call at the end of the study, or, if female, is postmenopausal

Exclusion Criteria:

* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
* The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic admission on Day -1.
* The subject has received a vaccination within the last 30 days prior to study drug administration
* The subject has a positive result for hepatitis B surface antigen, hepatitis C antibodies at Screening or is known to be positive for human immunodeficiency virus
* The subject has a known or suspected allergy to any of the components of the trial products or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the Investigator), or a history of severe anaphylactic reactions
* The subject is a smoker (any use of tobacco or nicotine containing products) in the last 6 months
* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medication within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day
* The subject has a recent history (within the last 2 years) of drug or alcohol abuse, or a positive drug screen at Screening or Day -1
Social Prescribing and Relationship Cognitive Strategies (SPARCS)

The study team is testing the acceptability and feasibility of two treatments for improving loneliness: Social Prescribing and Brief Cognitive Therapy.

For this pilot study, the study team have adapted these treatments for Collaborative Care and are studying whether these are practical and well-received by patients that might use them.

The study will take place at 2 University of Michigan sites.

Eligibility Criteria:
Inclusion Criteria:

* Screen positive for either or both of the following during routine clinic screening:

  * Social isolation in the past 6 months, according to the screening question "How often do you feel isolated from others?"
  * Suicidal ideation in the past 12 months, according to the 9th item of the Patient Health Questionnaire (HQ-9) (per protocol)
* Loneliness, according to the 3-item version of the University of California, Los Angeles (UCLA) Loneliness Scale (per protocol)
* Are currently receiving or are able to initiate Collaborative Care Management at to participant's study site

Exclusion Criteria:

* Currently receiving or have an active referral for specialty mental health or substance use disorder treatment outside of primary care
* Neurocognitively impaired according to chart diagnosis, self-report on the Eligibility Screening Survey, or inability to answer comprehension check questions during the Informed Consent process (per protocol)
* Unable to participate in the interventions and research assessments due to planned travel or limited phone access (e.g., does not own phone)
* Terminally ill or receiving of palliative care with less than 6 months life expectancy
The Role of Angiotensin Type I Receptor in the Regulation of Human Coronary Vascular Function

The renin angiotensin system (RAS) plays an important physiological and pathophysiological role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in the treatment of hypertension, cardiac failure and in some patients with myocardial infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and the vascular endothelium indicate that ACEI improve both endothelial dysfunction and metabolic coronary vasodilation, an effect that is partially mediated by bradykinin. The current protocol is designed to investigate whether the beneficial effects of ACEI on endothelial function are also partly due to inhibition of angiotensin II. The recent development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to specifically examine the effects of angiotensin II on vasomotor activity.

The renin angiotensin system (RAS) plays an important physiological and pathophysiological role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in the treatment of hypertension, cardiac failure and in some patients with myocardial infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and the vascular endothelium indicate that ACEI improve both endothelial dysfunction and metabolic coronary vasodilation, an effect that is partially mediated by bradykinin. The current protocol is designed to investigate whether the beneficial effects of ACEI on endothelial function are also partly due to inhibition of angiotensin II. The recent development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to specifically examine the effects of angiotensin II on vasomotor activity.

Eligibility Criteria:
Patient must be over 18 years of age requiring diagnostic cardiac catheterization will participate.

Women on chronic estrogen therapy are eligible for the study.

Patients investigated for chest pain syndrome with normal coronary arteries with and without risk factors for atherosclerosis, patients with coronary artery disease, and patients with heart failure.

No patients with unstable angina; significant left main disease (greater than 50% stenosis); Recent myocardial infarction (less than 1 month); Pregnancy, lactation; Allergy to losartan; Renal failure (creatinine greater than 2.5 mg/dl); Inability to withdraw ACE inhibitors.
S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial studies bone marrow samples from women with acute myeloid leukemia.

OBJECTIVES:

* Estimate the proportion of acute myeloid leukemia (AMLs) that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors.
* Explore whether there is an association between the cellular origin of AML (i.e., origination in CD33+ precursors or not) and cytogenetic, molecular, and other patient characteristics.
* Explore whether overall survival (OS), event-free survival (EFS), disease-free survival (DFS), response rate (RR), or relapse rate is improved for patients with AMLs that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors compared to patients with clonally involved cells not detected.

OUTLINE: Archived bone marrow samples are analyzed for CD33+ progenitors, X-chromosome inactivation, and somatic mutations (t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, KIT) by fluorescence-activated cell sorting, long-term culture in hypoxic condition in cytokine-containing liquid media, and flow cytometry. Results are then compared with each patient clinical data.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnostic bone marrow specimens from female patients with untreated AML undergoing intensive ("3+7"-like) induction chemotherapy
* Specimens from the South Western Oncology Group (SWOG) protocols S0106 (age 18 to 60 years), excluding patients who received gemtuzumab ozogamicin (GO), and S9333 (age \> 60 years)

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
MSCs Source of Sweat Gland Cells of Large Area Skin Injury Patients Transplant of the Wound

The main purpose of this test is to assess the umbilical cord mesenchymal stem cells (MSCs) UC between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form when the age of 18 and 60 years old or less or more men or women (not pregnancy) The burned area: 10-20% TBSA, can satisfy the self control Time: early for skin grafts For location: limbs, chest and back

Exclusion Criteria:

* Serious allergic constitution; Have influence on the speed of wound healing of chronic disease patients; According to the researcher's judgment, may endanger the safety of the subjects or scheme compliance of any chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, respiratory disease, nerve diseases of the nervous system, blood system diseases, etc.; Clinical researchers or for other reasons can't cooperate with the doctors, and other information is not suitable for clinical study of patients.

Can not meet the requirement of the long-term follow-up of patients.
Cilostazol Stroke Prevention Study for Antiplatelet Combination

To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for secondary prevention of ischemic stroke in high-risk patients for stroke


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of noncardioembolic IS that developed between 8 and 180 days before the start of the protocol treatment
* Patients with a responsible lesion identified by MRI
* Patients aged 20 to 85 years old when providing informed consent
* Patients taking clopidogrel or aspirin alone as antiplatelet therapy when providing informed consent
* Patients meeting at least one of the following criteria a-c:

  1. at least 50% stenosis of a major intracranial artery (to the level of A2, M2, or P2)
  2. at least 50% stenosis of an extracranial artery (the common carotid artery，internal carotid artery，vertebral artery，brachiocephalic artery，or subclavian artery)
  3. Two or more of the following risk factors

     * Aged 65 years or more
     * Diabetes mellitus
     * Hypertension
     * Peripheral arterial disease
     * Chronic kidney disease
     * History of IS (excluding the index IS for this study)
     * History of ischemic heart disease
     * Smoking (only current smokers)
* Patients considered to be able to visit the study site for ambulatory care throughout the observation period
* Patients who provided written informed consent

Exclusion Criteria:

* Patients with emboligenic heart disease
* Patients taking any anticoagulant agents
* Patients who cannot undergo MRI examination for reasons such as claustrophobia and implanted pacemaker
* Patients scheduled to undergo any surgery, such as percutaneous angioplasty, stent placement, and bypass grafting, during the study period
* Patients with a drug-eluting coronary stent implanted within one year
* Patients with a history of symptomatic non-traumatic intracranial hemorrhage, any other hemorrhagic disease (eg, active peptic ulcer), bleeding predisposition, or blood clotting disorders
* Patients with a history of hypersensitivity to cilostazol
* Patients with congestive heart failure or uncontrolled angina pectoris
* Patients with thrombocytopenia (platelet count ≦ 100,000/mm3)
* Patients with severe liver or renal dysfunction
* Women who are pregnant, breast-feeding, or of child-bearing potential
* Patients with a malignant tumor requiring treatment
* Patients who are taking aspirin, and meet any of the following criteria:

  * History of hypersensitivity to aspirin or salicylic acid analogues
  * Current peptic ulcer
  * Aspirin-induced asthma or its history
* Patients who are taking clopidogrel, and meet the following criterion:

  ・History of hypersensitivity to clopidogrel
* Patients who are participating in any other clinical studies
* Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study
Validity of Brain Metastasis Risk Predictive Model in Hormone Positive Breast Cancer Patients

This study aims to validate a prediction model of brain metastasis risk for females with HR+ breast cancer by using variables collected at diagnosis.

1. Data collection:

   Age at BC diagnosis, tumor size, axillary adenopathy, clinical stage, HER2 status, Ki67 proliferation index and the modified Scarff-Bloom-Richardson grade of differentiation.
2. Analysis Plan:

   Continuous variables as means and standard deviation (SD) if they follow a normal distribution; if not, as medians and IQR (interquartile range). Numbers and percentages display categorical variables.
3. Model validation:

The association between covariates and the diagnosis of brain metastases by performing logistic regression analyses; odds ratio (OR), 95 % confidence intervals (CI), and p-value will be estimated. Variables with a p-value \< 0.05 in the univariate logistic regression analysis will be further assessed in a multivariate logistic regression analysis.

For the clinical use of the model, we will use a score to each variable as that designed by Cacho-Díaz B. et. al. then, we will categorize patients into three risk groups according to the sum of the scores. We will employe a Cox regression analysis to assess each group's risk of developing brain metastases. Adjusted hazard ratios (aHRs), 95 % CIs, and p values will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of HR-positive primary invasive breast cancer.

Exclusion Criteria:

1. Patients if they were diagnosed with brain metastases at the time of initial breast cancer diagnosis or within the subsequent three months.
2. Bilateral breast cancer.
3. Synchronic cancer (i.e., lung cancer, melanoma).
4. Paitents presenting neurologic symptoms without follow-up or lacking a contrast-enhanced magnetic resonance image (cMRI).
5. Incomplete clinicopathological information at the time of diagnosis.
Effect of Colloids Versus Crystalloids on Heart Mechanics: a Double-blind Cross Over Randomized Trial

The debate over whether to use colloid or crystalloid solutions for fluid resuscitationis still ongoing. Colloid solutions consist of large molecules that generally cannot pass through healthy capillary membranes, whereas crystalloid solutions contain ions that easily move from the intravascular space to the interstitial compartment. Therefore, it is traditionally argued that colloids are more effective at expanding intravascular volume, with a suggested ratio of 1:3 compared to crystalloids. However, there is currently limited evidence to suggest that resuscitation with one type of fluid is more effective or safer than t he other. Despite these theoretically advantageousphysiological properties, colloids have not demonstrated a clear hemodynamic benefit over crystalloids. We hypothesized that these unexpected discrepancies may be attributed to different mechanical heart responses.


Eligibility Criteria:
Inclusion Criteria:

* HealthyVolunteers with age \> 18 years without medical history

Exclusion Criteria:

History of cardio vascular diseases Diabetes Hypertension Currentpregnancy Knownallergy to one of the tested products Leftventricular dysfunction discovered at baseline assessment Valvular heart or other structural diseases discovered at base line assessment
Barriers to Treatment in Obese Adolescents

The purpose of this study is to identify significant racial and ethnical differences in risk factors for development of obesity and weight loss in adolescents in Central Virginia

* Participation for 6 months in a program incorporating exercise, nutritional counseling and behavioral support leads to measurable improvements in overall fitness, metabolic indicators and loss of body fat for obese adolescents.
* Degree of loss of body fat, improved overall fitness and improvements in metabolic indicators can be correlated with the degree of compliance and participation for 6 months in the program.
* Parental involvement and support can be correlated with the degree of compliance and participation in the program.
* Socioeconomic factors can be correlated with the degree of compliance and participation in the program.
* Cultural differences in diet, attitudes toward body shape, and family dynamics can be correlated with success or failure in a weight loss program.
* Individual differences in self-esteem, self-discipline and feelings of connectedness with family members can be correlated with success or failure in a weight loss program.

Eligibility Criteria:
Inclusion Criteria:

* Age 11-18
* Above 95th percentile for weight
* Reside within 30 miles of program site
* Ability to comprehend basic instructions
* Ability to perform basic exercise movements

Exclusion Criteria:

* Having a metabolic disorder that causes weight gain
* Having a cognitive deficit that impacts learning and comprehension
* Having a physical defect that prevents exercise
Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167

The purpose of this study is to investigate the pharmacokinetic (PK) properties of various modified release tablet formulations of Lu AF11167 (Part A) and to investigate the pharmacokinetic (PK) properties of a modified release tablet formulation of Lu AF11167 in a fed and fasted state and following multiple dosing (Part B).


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women ≥18 and ≤45 years of age with a body mass index (BMI) of \>18.5 and \<30.0 kg/m2.
* Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status.
* Other pre-defined inclusion and exclusion criteria may apply.
Primary Angioplasty for STEMI During COVID-19 Pandemic (ISACS-STEMI COVID-19) Registry

The ISACS STEMI COVID-19 has been established in response to the emerging outbreak of COVID-19 to provide a European overview to estimate the real impact of COVID-19 pandemic on treatment and outcome of STEMI by primary angioplasty, and to identify any potential category of patients at risk for delay to treatment or no presentation.

This is a retrospective multicenter registry including at least 40 European primary PCI centers with \> 120 primary PCI/year (with expected average \> 10/month), with the case load of STEMI not expected to be affected by a potential planned reorganization of the STEMI network. The inclusion period will be of 2 months (from March 1st until April 30th). The data will be compared with those retrospectively collected in the same time window of 2019.

Inclusion criteria: STEMI treated by primary angioplasty. Primary study outcome: Number of STEMI patients undergoing primary angioplasty. Secondary study outcomes: Ischemia time and the number of late presenters (\> 12 hours from symptoms onset); 3) Door-to-balloon time and the number of patients with a DTB \> 30 minutes); 4) In-Hospital mortality.

Data Collection: Data will be collected anonymized through a dedicated CRF. Each center will identify a local Principal Investigator. We will collect information on the study center, demographic, clinical, procedural data. Furthermore, we will collect data on total ischemia time, door-to-balloon time, type of access to the emergency system, COVID positivity, PCI procedure, data on in-hospital mortality.

Eligibility Criteria:
Inclusion Criteria: STEMI Patients undergoing mechanical reperfusion

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