cyrilzakka/clinical-trials huggingface dataset:
Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in the laboratory may help doctors learn how patients respond to treatment.

PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the tumor tissue.

OBJECTIVES:

Primary

* Determine the efficacy, of imatinib mesylate, in terms of achieving a therapeutic tumor:plasma concentration ratio, in patients with primary malignant glioma.

Secondary

* Correlate tumor grade (low vs high) and/or tumor enhancement on MRI with tumor concentration of this drug in these patients.,

OUTLINE: Patients receive oral imatinib mesylate once daily for 7-12 days. Patients then undergo surgical resection.

Blood and tissue samples are collected at the time of surgery and analyzed for imatinib mesylate concentration.

After completion of study treatment, patients are followed for 7 days.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignant glioma of 1 of the following subtypes:

  * Low-grade glioma
  * Anaplastic astrocytoma
  * Anaplastic oligodendroglioma
  * Glioblastoma multiforme
* Unifocal disease that is progressive or recurrent after prior radiotherapy and/or chemotherapy
* Scheduled to undergo surgical resection

  * Able to undergo maximal surgical resection of tumor mass

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Mini Mental Status Exam ≥ 15
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≥ 1.7 mg/dL
* BUN ≤ 2 times upper limit of normal (ULN)
* Transaminases ≤ 4 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
* No other medical illness that would preclude study treatment, including any of the following:

  * Serious infection
  * Uncontrolled hypertension
  * Unstable angina pectoris
  * Uncontrolled cardiac dysrhythmia

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Recovered from all prior therapy
* At least 4 weeks since prior investigational drugs
* No more than 1 prior chemotherapy regimen
* No concurrent chemotherapy, biologic therapy, or radiotherapy
* No concurrent medications that may interact with imatinib mesylate or interfere with hepatic cytochrome P450 system
Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

The primary objective of this study was to evaluate the efficacy of zanubrutinib in participants with centrally confirmed relapsed or refractory MCL.


Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnostic report had to include evidence for morphological and cyclin D1 or t (11; 14).
2. Eastern Cooperative Oncology Group performance status of 0-2.
3. Measurable disease by computed tomography/magnetic resonance imaging.
4. Received prior regimens for MCL.
5. Documented failure to achieve any response, (stable disease or progressive disease during treatment) or documented progressive disease after response to the most recent treatment regimen.
6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN).
7. Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).
8. Life expectancy of \> 4 months.

Key Exclusion Criteria:

1. Current or history of central nervous system lymphoma.
2. Prior exposure to a BTK inhibitor before enrollment.
3. Prior corticosteroids with anti-neoplastic intent within 7 days.
4. Major surgery within 4 weeks of screening.
5. Toxicity must have recovered from prior chemotherapy.
6. History of other active malignancies within 2 years of study entry.
7. Currently clinically significant active cardiovascular disease.
8. QT interval corrected with Fridericia's formula \> 450 microseconds or other significant electrocardiogram abnormalities.
9. Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
10. Known human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction).

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Evaluation of the Informational Content of Setup Verification Images for Patients Receiving Breast Radiation Therapy (Anterior EPI)

The purpose of this study is to determine if an alternative imaging protocol done at the time of radiotherapy treatments for patients with breast cancer can improve accuracy in patient set-up.

Accurate patient positioning is critical in Radiation Therapy. Electronic imaging is used to compare a patient's actual treatment position, with that which was planned from an initial CT scan. Radiation Therapists compare planned and actual images using analysis software to determine if differences are within acceptable tolerances. At the VIC, we use 3 different breast imaging protocols depending on the patient set-up and treatment technique. Findings from our recent retrospective planning study show that our current electronic imaging protocols miss some clinically significant patient set-up errors, particularly in the medial/lateral direction, and that these errors can be better detected with the use of an anterior image. The purpose of this study is to test these findings prospectively in clinical practice, through the direct comparison of our current protocols with a proposed new protocol, which would include an anterior electronic portal image (EPI).

Eligibility Criteria:
Inclusion Criteria:

* All patients (male or female) receiving tangential breast/chest wall radiotherapy only, or three or four field breast/chest wall and nodal radiotherapy will be eligible.

Exclusion Criteria:

* Those patients receiving partial breast treatment, those patients requiring an electron match field, those on another breast cancer radiotherapy trial, those who require radiotherapy using deep inspiration breath hold or multi-field intensity modulated radiotherapy, and all non-breast cancer patients will be excluded.
Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device by Emergency Medical Technician in Ambulance

In this study, the investigators compare timely acquirement and effectiveness of 12-lead ECG using patchy-type wireless versus using defibrillator which contain ECG examination function in ambulance.

The purpose of this study is to determine the difference of timely acquirement of 12-lead ECG using two different systems and the difference of efficiency of ECG examination in ambulance between two groups.

The participants in this simulation study were divided randomly into 2 groups :

Group A is performing an ECG examination on mock patient using defibrillator which contained 12-lead ECG checking function. And take a 15 minutes wash out period. After the wash out period, group A subject performing an ECG examination using patchy-type wireless device.

Group B subject is performing an ECG examination on mock patient using patchy-type wireless device first, and take a 15 minutes wash out period. After the wash out period, group B performing an ECG examination using defibrillator which contain 12-lead ECG function.

Both group's ECG examination is performing in the ambulance.


Eligibility Criteria:
Inclusion Criteria:

* Who have a certification of Emergency Medical Technician in korea and have a nurse license in korea.
* who currently engaged of emergency medical dispatch.

Exclusion Criteria:

* A subject who did not agree with this study
Health Professions Students and Faculty Perceptions of Poisoning Severity

Inaccurate perceptions of the severity of an exposure may result in unnecessary visits to the Emergency Department or Health Care Facility which can result in crowding of Emergency Departments, unnecessary utilization of valuable health care resources, unnecessary treatments, and or mistakes / errors resulting in harm to the patient.

Inaccurate perceptions about the severity of an exposure can result in delays in proper evaluation and treatment resulting in harm or in some cases death of the patient.

Consumers and health professionals are often surprised about the toxicity (or lack of toxicity) after exposure to a number of pharmaceutical or non-pharmaceutical agents. Past experience with the survey used in this study has indicated that consumers and health professional perform about the same. Most individuals answer less than 50% of questions incorrectly.

Pharmacy students will be asked to participate in a short (5-7 minutes) survey (see below) that contains 21-short cases involving an exposure to a pharmaceutical or non-pharmaceutical agent. All cases involve children less than 19 years of age. Participants will be asked to indicate their year in pharmacy school (1st or 2nd) and their gender (f/m). The survey will be given after a scheduled examination or other classroom activity and will not involve class time. Students will be provided a link to an online version of the survey.

Conclusions will be derived through the analysis of the data. At a later date, all students in the class (whether they participated in the survey or not)students will be provided a link to video that describes the correct answers to each of the cases and an explanation.

Eligibility Criteria:
Inclusion Criteria:

* All pharmacy students who agree to participate

Exclusion Criteria:

* None
A Prospective, Multi-center Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency

To compare the efficacy of Vitamin D3 B.O.N. Intramuscular Injection within 12 weeks with that of placebo in adults with Vitamin D Deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with vitamin D deficiency

Exclusion Criteria:

* Subjects who experienced a hypersensitivity to the cholecalciferol
* Subjects with renal impairment
* Subjects with Hypercalcemia
* Subjects with Hypercalciuria
* Subjects with clinically doubted calcium stone
* Subjects diagnosed with sarcoidosis
* Subjected diagnosed with pseudo-hypoparathyroidism
* Subjected with malignancy
* Subjects with clinically significant cardiovascular or lung impairment Judged by the investigator
* Subjects with the below laboratory abnormality (Platelet, WBC, Absolute neutrophil count, Albumin, AST or ALT)
* Subjects who are to take vitamin D supplements during the study period
A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia

The main purpose of this study is to determine the tolerability and side effects related to LY3875383 given as a single injection under the skin to healthy participants and participants with elevated triglyceride (TG) levels.The study will also assess how fast LY3875383 gets into the blood stream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of either LY3875383 or placebo.The study will be conducted in four parts (A, B, C and D) and may last up to approximately 28 to 56 weeks including screening.


Eligibility Criteria:
Inclusion Criteria:

All participants:

* Have a body mass index (BMI) between 18.5 and 40 kilograms per square meter (kg/m²), inclusive.
* Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).

Healthy participants (Part A):

• Participants must be overtly healthy, as determined by medical evaluation.

For Part B:

• Participants must be first-generation Japanese, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.

Hypertriglyceridemia participants (Parts C and D):

For Part C:

* Have history of very high triglyceride (lipid) level 500 mg/dL ≤ TG \<2000 mg/dL, which needs to be further confirmed at screening.
* Participants must be on a lipid-modifying diet and can be on stable lipid-lowering drugs (LLDs) for at least 8 weeks before screening and plan to continue the same throughout the study duration.

For Part D:

* Have history of high triglyceride (lipid) level between 150 mg/dL and 500 mg/dL inclusive at pre-screening or based on medical history and confirmed at screening and Low-density lipoprotein cholesterol (LDL-C) level of ≥40 mg/dL.
* Participants must be on a stable moderate or high-intensity dose of a statin for at least 8 weeks before screening and plan to continue the same medication and dose throughout the study duration.

Exclusion Criteria:

All participants:

* Participants must not be currently participating in or completed a clinical trial within the last 30 days
* Have donated blood of more than 500 mL within the previous 3 months
* Have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
* Participants must not be heavy alcohol drinkers or cigarette smokers.

For Part C: Have active pancreatitis within the last 6 months
Prognosis of Extremely Premature Birth

Pregnant women at risk of giving birth before 28 weeks' gestational age will be enrolled. Fetal circulation will be studied and blood for inflammatory parameters will be collected. If birth occurs before 28 weeks, detailed information on clinical course of the newborn until discharge from the neonatal intensive care unit will be recorded,and specimens of amniotic fluid, placenta, blood and urine will be collection for inflammatory parameters. After discharge the children will be followed according to a specific protocol until 5 years of age.

The study includes a regional cohort (Western Norway) of approximately 50 extremely preterm infants born per year over a three year period. Detailed information on fetal condition (growth, circulation, infection), neonatal resuscitation and clinical course (details on ventilatory support, circulation, pulmonary function as assessed with a neonatal spirometry technique, cerebral imaging, nutrition, growth) will be recorded. Biobank samples of blood and amniotic fluid from the mother, and from placenta, blood, urine, and tracheal aspirates will be collected form the infant, primarily to examine for inflammatory parameters. After discharge, follow-up at 6, 12, 36 and 56 months will be conducted using standardized tests (Ages \& Stages, INFANIB, Denver Developmental Screening test, Bayley scales, WPPSI and ABC movement tests).

Eligibility Criteria:
Inclusion Criteria:

* Born with gestational age less than 28 weeks

Exclusion Criteria:

* None
Multiscale Omics for the Development of a Cohort Database and Study Platform in Breast Cancer Survivors

This study gathers information to create a database to improve the ability to diagnose cancer, predict long term health of breast cancer patients, and help develop future treatment products. This study will provide a foundational platform for therapeutic development and intervention studies in the future and may for therapeutic development and intervention studies in the future, and may advance researchers understanding of the contribution gut bacteria to altered circulating estrogens in breast cancer survivors.

PRIMARY OBJECTIVE:

I. To use multiscale omics to build a cohort database that can be used as a reference population in support of multivariate analysis, predictive modeling, and development of natural product therapeutics and precision medicine applications for breast cancer survivors.

SECONDARY OBJECTIVE:

I. To detect unique patterns of variance between 1) targeted serum metabolites, 2) plasma metabolome, 3) gut microbiome community structure, 4) gut microbiome metabolome, 5) urine metabolome, 6) quality of life measures, and 7) breast cancer survivors (BCS) symptoms by using multivariate analysis, machine learning tools, and artificial intelligence applied to the large data sets developed in this trial.

OUTLINE:

Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection.

Eligibility Criteria:
Inclusion Criteria:

* BCS GROUP
* Female patients diagnosed with breast cancer age 18 - 75, stages 0 through 3 at time of diagnosis
* Who have completed active therapy (including surgery, radiation, and/or chemotherapy)
* Able to speak English and complete surveys and provide the specimen (willing to follow the sample collection instructions)
* Able to read, understand and sign inform consent
* CONTROL GROUP
* Healthy Volunteers age 18 - 75
* Able to speak and read English, complete consent, surveys, and provide specimens

Exclusion Criteria:

* Unable to give written consent
* Unable to fast before providing blood and urine
* Pregnant women (per participant report) and males
* Unwilling to travel to Mayo Clinic Rochester to provide bio specimens
Bisphosphonate Therapy in MONA Spectrum Disorder

Multicentric osteolysis, nodulosis and arthropathy (MONA) spectrum disorder is a rare inherited progressive skeletal disorder caused by mutations in the matrix metalloproteinase 2 (MMP2) gene. Treatment options are limited. The investigators reviewed the outcome of patients affected with MONA and treated with intravenous bisphosphonates in the clinical Center.

Assessment of the patients:

After informed consent had been obtained from the patients affected from MONA spectrum disorder the investigators assessed the patients regarding the following characteristics: consanguinity, clinical symptoms at diseases on-set, age at on-set of symptoms and age at diagnosis, cognitive development, progression of clinical symptoms related to the diagnosis, molecular investigations, associated disorders as well as therapies besides bisphosphonate therapy. Informed consent from the patients was also obtained to publish the patient's photographs. All investigations are performed according to the relevant ethical guidelines.

Bisphosphonate therapy:

The reported patients received intravenous bisphosphonate therapy either with pamidronate (1 mg/kg/d on two consecutive days every 3 months) or zoledronate (a single dose of 0.05 mg/kg/day every 6 month).

Evaluation of disease progression and therapeutic success:

To assess both progression of MONA spectrum disorder and therapeutic success the patients were regularly evaluated clinically in 3 to 6 month intervals. Clinical evaluation comprised an internal, neurological and orthopaedic status as well as a general assessment of neurocognitive function. Additionally, need for oral analgesic therapy was documented. In irregular intervals, depending also on the clinical symptoms, x-rays of hand and feet were taken and a densitometry of the total body, lumbar spine and hip was performed.

Eligibility Criteria:
Inclusion Criteria:

* genetically confirmed MONA spectrum disorder
* treatment with bisphosphonates intravenously
* positive informed consent

Exclusion Criteria:

* genetically confirmed MONA spectrum disorder treated otherwise than with bisphosphonates
* oral treatment with bisphosphonates in MONA spectrum disorder
* other inherited osteolysis syndromes than MONA spectrum disorder
Oculomotor Assessment of Traumatic Brain Injury (TBI)

The purpose of the proposed study is to compare the sensitivity and specificity of three oculomotor test devices in normal subjects versus subjects with history of TBI. The study is designed as a prospective research project in which a group of 120 normal controls without a history of TBI will be compared to another group of 120 participants (total of 240) who have a confirmed history of TBI. Each participant will complete the TBI assessment protocol for each of three separate devices (Neuro Kinetics, SyncThink, and Oculogica). The order of the devices will be counter-balanced across participants. Participants will also be screened for vestibular migraine and visual vertigo, which are two conditions that influence oculo-vestibular perception in normal and TBI patients and might influence the results from the three oculomotor devices. Data from each device will be utilized to perform AUC analyses to determine the respective sensitivity and specificity for each.


Eligibility Criteria:
All participants must be DEERS eligible, no exceptions!

Inclusion Criteria:

* Must be between 18 and 45 at time of screening (upper age restriction is to prevent confounding with age-related physiological changes).
* Must be able to provide written informed consent.
* Must be able to read and understand questionnaires and consent forms.
* Must have corrected binocular acuity of at least 20/40 for near distance with or without single-power corrective lenses or contacts and absent of ocular injury or disease.

Control Group - No history of TBI or any history of severe or penetrating TBI

TBI Group - Must have a documented history of a TBI occurring within the last 10 years.

Exclusion Criteria:

* Current or previous neurological disease, including: stroke, congenital brain malformation, degenerative illness such as multiple sclerosis, epilepsy or seizure (other than febrile seizure).
* Current or previous ocular disease/injury, including: Glaucoma or increased pressure in the eyes, structural damage to ocular tract and ocular cortex, etc.
* History of vestibular disorder (e.g., with symptoms of clinical vertigo)
* Binocular vision not correctable to 20/40 for near distance
* Use of tobacco or caffeinated products less than four hours before test session
* Consumption of alcohol within past 24 hours
Breathwork-assisted Treatment for Cannabis Use Disorder

The purpose of this proof-of-concept study is to evaluate the safety, feasibility and acceptability of a breathwork workshop intervention in individuals with cannabis use disorder.

This study will test a 1-week breathwork workshop for treatment-seeking adults with a diagnosis of cannabis use disorder. The intervention consists of an enhanced breathing session with evocative music to facilitate experiencing non-ordinary states of consciousness, in addition to brief therapeutic interventions based on Motivational Interviewing and Mindfulness-based Relapse Prevention (MBRP). The primary aim is to test the acceptability, feasibility and safety of enhanced breathwork in a therapeutic framework for cannabis use disorder. In addition, the investigators seek to understand the phenomenology of breathwork that may explain any change related to addictive behaviors, as well as biological changes that occur during the breathwork session through heart rate variability and electroencephalography.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for active cannabis use disorder.
* Seeking treatment for their cannabis use

Exclusion Criteria:

* Meets DSM-V criteria for schizophrenia or any psychotic illness or any dissociative disorder (Dissociative identity disorder, Dissociative amnesia, Depersonalization/derealization disorder).
* Active substance use disorder except for cannabis, nicotine, and caffeine.
* History of severe withdrawal symptoms (i.e withdrawal seizures).
* History of dementia, epilepsy or seizures, cardiac arrhythmia, pacemaker/defibrillator, heart failure, asthma, panic disorder and other respiratory illnesses (ie: COPD).