Kornimate/medical-research-clean huggingface dataset:
expanded access use of onc201 in a patient with diffuse intrinsic pontine gliomas

Conditions: Glioma

Summary: this is an intermediate-size expanded access protocol to provide onc201 to patients with diffuse intrinsic pontine gliomas who cannot access onc201 through clinical trials.


Eligibility criteria:
inclusion criteria: 1. patient with dipg who failed at least one line of prior therapy such as focal radiation therapy 2. patient must be \> than 6 months and \< 18 years of age. 3. confirmed evidence of disease progression from immediately prior therapy or refractory to the immediately prior treatment. 4. karnofsky/lansky performance status ≥ 50. 5. adequate organ and marrow function as defined below: 1. absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to treatment (cycle 1 day 1, c1d1) ________________________________________________________________________________ confidential page 3 of 45 2. hemoglobin\>8.0 mg/dl without red blood cell transfusion ≤ 3 days prior to c1d1 3. total serum bilirubin\<1.5 x upper limit of normal (uln) 4. ast (sgot)/alt (sgpt)≤2 x uln;; ≤ 5 x uln if there is liver involvement secondary to tumor 5. serum creatinine≤ 1.5 x uln (or creatinine clearance ≥ 60 ml/min/1.73 m2) 6. ability to understand and the willingness to sign a written informed consent document by the patient or their legal guardian. 7. if patient is of child--bearing age, female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. the decision of effective contraception will be based on the judgment of the principal investigator or a designated associate. 8. patient must be able to swallow capsules and retain orally administered medication. exclusion criteria: 1. body weight \>10kg. 2. known active bacterial, fungal or viral infection including hepatitis b (hbv), hepatitis c (hcv). 3. known human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids)--related illness. 4. active or prior plasma cell leukemia (defined as either 20% of peripheral wbc comprised of plasma/cd138+ cells or an absolute count of 2 x 10\^9/l). 5. solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia. 6. any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism. 7. other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.
barriers to screening breast mri utilization among patients at elevated risk

Conditions: Breast Cancer

Summary: this study seeks to develop an explanatory framework for breast mri utilization to inform future interventions. the health services utilization model (hsum) will guide the selection of specific participant-level factors for examination, including predisposing characteristics (knowledge, health/cultural beliefs), enabling resources (social support, cost/insurance coverage), and perceived need (perceived susceptibility, provider recommendation).


Eligibility criteria:
inclusion criteria: * ability to speak/read english * within 2 years of last screening mammogram * pathogenic brca1/2 mutations or estimated lifetime risk ≥20% per the national cancer institute (nci) breast cancer risk assessment tool (bcrat) exclusion criteria: * women who have received a prior diagnosis of breast cancer

Keywords: pathogenic brca 1/2 mutation
a bioequivalence study of sparc_147709 in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: safety and bioequivalence of sparc_147709


Eligibility criteria:
inclusion criteria: * availability for the entire study period and willingness to adhere to protocol requirements. * diagnosis of multiple myeloma and eligible for receiving doxorubicin liposome * 18 years of age or older * no evidence of underlying disease (except multiple myeloma) exclusion criteria: * history or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride * history of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease. * history of smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day). * positive result to hiv, hcv, rpr and hbsag.

Keywords: multiple myeloma bio-equivalence
duration of treatment with tyrosine kinase inhibitors in the treatment of metastatic renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this study is a prospective, non-interventional, non-controlled, multi-center, observational cohort study. the medication is prescribed within the regular practice of the physician. duration and dosage of treatment is solely at the discretion of the attending physician. the primary objective of this study is to assess duration of treatment in turkish renal cell carcinoma patients treated with tkis (tyrosine kinase inhibitors) who could not tolerate prior cytokine treatment within the first month of treatment.


Eligibility criteria:
inclusion criteria: * to be diagnosed as metastatic renal cell carcinoma * previous cytokine therapy * to sign informed consent form (icf) exclusion criteria: * patients not willing to sign informed consent form or who withdraw their consent

Keywords: renal cell carcinoma tki turkey observational
modifying virtual reality analgesia with low-dose pain medication

Conditions: Virtual Reality Therapy

Summary: the purpose of this study is to determine how pain relief is modified when the investigators combine the virtual reality based snow world game with certain pain medications.

this is a randomized, double-blind, placebo-controlled, within subject 2x2 factorial, repeated measures study. research participants will play two versions of the virtual reality based video game "snow world" and be given thermal and electrical stimulus. each of two study visits will be identical with the exception of whether or not the participant will receive an iv infusion of a low dose pain medication or a saline placebo.

Eligibility criteria:
inclusion criteria: * healthy male and females between the age of 18 and 60 years * ability to communicate orally * ability to read and understand english * body mass index between 20-35 exclusion criteria: * women who are pregnant, trying to become pregnant, or who are breastfeeding * history of alcohol or substance abuse * major medical illness; including history of migraine headaches, seizures, brain injury, or peripheral neuropathy * current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids * predisposition to severe motion sickness * unusual sensitivity or lack of sensitivity to pain * urine toxicology positive for opioids or benzodiazepines
comparison between enlite and flash glucose monitoring

Conditions: Type1 Diabetes Mellitus

Summary: 1. the accuracy of the sensors (flash vs enlite glucose monitoring) will be evaluated with a standardized breakfast test. patients receive a standardized breakfast. the usual insulin bolus will be administered at breakfast. after breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. at the same time, the glucose value shown by the sensors will be noted. a comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose. 2. patient satisfaction will be evaluated using a questionnaire that will be completed after the enlite sensor has been worn for 1 month. 3. the development of skin reactions will be checked by a short questionnaire, supplemented with a picture of possible skin phenomena. 4. the data recorded by the freestyle sensor (average glucose,% above target,% within target,% under target, amount of hypoglycemia) in the month prior to sensor switching will be compared to the same data recorded by the enlite sensor during the first month of use.


Eligibility criteria:
inclusion criteria: * children (5 to 18 years) * diagnosis of type 1 diabetes mellitus * treatment is an insulin pump and wearing a freestyle flash libre glucosesensor exclusion criteria: -

Keywords: enlite glucose monitoring accuracy usability skin reactions type 1 diabetes mellitus
long term follow up in sickle cell patients treated by hydroxyurea

Conditions: Sickle Cell Anemia; Sickle Cell Thalassemia

Summary: hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to sca. several studies were published with relative short term follow up in pediatric and young adult age. the purpose of this study is to assess the long term follow up in a group of patients that initiated hydroxyurea treatment in childhood.

hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to sca. several studies were published with relative short term follow up in pediatric and young adult age. the purpose of this study is to assess the long term follow up in a group of patients that initiated hydroxyurea treatment in childhood. a long term follow up will be recorded in a cohort of twenty sca patients treated by hydroxyurea for a period between 5 to 12 years. the frequency of vaso-occlusive crises, acute chest syndrome, blood transfusions, and hospitalization will be recorded retrospectively. also the mean hgb level and hgb f percentage will be summarized.

Eligibility criteria:
inclusion criteria: * all patients treated by hydroxyurea in the pediatric hematology unit.

Keywords: sickle cell anemia sickle cell thalassemia hydroxyurea
tumor microenvironment

Conditions: Lung Adenocarcinoma

Summary: cancer immunotherapy has the great potential to achieve long-term survival in patients with a solid malignancy. however, the beneficial effect of cancer immunotherapy is seen in only a minority of patients. mounting evidence suggests that immunosuppressive features in the tumor microenvironment prevent an effective antitumor defense. the aim of the investigators is to comprehensively analyze the cytokine profile and the tumor immune infiltrate in the tumor microenvironment and to investigate its prognostic significance in patients with radically resected lung adenocarcinoma.


Eligibility criteria:
inclusion criteria: * lung adenocarcinoma * tumor stage ib and ii * with or without adjuvant therapy * complete surgical resection (r0) * no distant metastasis at the time of surgery (m0) exclusion criteria: • second cancer within 5 years
efficacy and safety of insulin detemir in type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to compare the efficacy and safety of insulin detemir and insulin nph in adults with type 1 diabetes on blood glucose control.


Eligibility criteria:
inclusion criteria: * duration of type 1 diabetes for at least 12 months * bmi below 35 kg/m2 * hba1c between 7.0-12.0% * current treatment with preprandial short acting insulin and insulin nph once or twice daily for at least 6 months * fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the investigator exclusion criteria: * known or suspected allergy to trial product or related products * previous participation in this trial * receipt of any investigational products within the last 2 months prior to this trial * drug or alcohol dependence * pregnancy, breast-feeding or intention of becoming pregnant
computer guided buccal cortical plate separation for removal of calcified benign odontogenic tumors affecting mandibular angle region

Conditions: Odontogenic Tumors; Odontoma

Summary: computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. the guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.

computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. the guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.

Eligibility criteria:
inclusion criteria: * patients with well-defined radiopaque lesion affecting angle region, its conventional removal may compromise the bone continuity and leads to pathological fracture indicating the need of buccal cortical plate separation technique exclusion criteria: * patients with any medical condition contraindicating the surgical procedures were excluded
central venous pressure and right atrial pressure measurements in supine, semi-recumbent and trendelenburg position

Conditions: Critically Ill

Summary: intensive care is directed towards patients with severe illness or risk of serious outcomes following, for example, surgery. central venous pressure (cvp) is an important part of the hemodynamic assessment of patients in surgery and the intensive care unit (icu). cvp is normally measured via a central venous catheter (cvc) inserted through the subclavian or internal jugular vein, with the tip placed at the junction to the right atrium. a pressure tubing is connected to one of the branches of the cvc and then connected to a pressure sensor that sends a digital signal to the monitoring screen where cvp can be read in mmhg. to accurately read cvp, the pressure sensor must be positioned at the level of the right atrium. different external reference points are used nationally and internationally to locate the correct height for the pressure sensor. this study aims to investigate the most commonly used external reference points for cvp measurement in various body positions compared to cvp measured via a solid state pressure catheter in the right atrium (rap).

a millar mikro-cath solid state pressure catheter is inserted through one of the medial lines of the cvc and guided in position by the pressure curve and verified in position by ultrasound. cvp is compared to rap in supine, semi-recumbent, trendelenburg and lateral position. cvp, rap and arterial pressure is recorded in each session with biopac acqnowledge. in each body position peep is raised 5 cmh20 and then lowered 5 cmh20. ventilator settings, capillary refill time, perfusion index are collected in each setting and before and after peep adjustments.

Eligibility criteria:
inclusion criteria: * critically ill patients in mechanical ventilation with an arterial line and a four or five lumen cvc. exclusion criteria: * under 18 years of age * in a dynamic phase of their illness i.e. ongoing treatment of severe circulatory or respiratory failure * positive end-expiratory pressure (peep) \>14 cmh20 or intolerance to change of body position.
comparison of combination of beclomethasone dipropionate and formoterol fumarate versus single components assessed by knemometry and urinary cortisol measurements in asthmatic children

Conditions: Childhood Asthma

Summary: this is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.


Eligibility criteria:
inclusion criteria: * prepuberal male and female outpatients, ≥ 5 and ≤ 11 years old in tanner stadium i according to investigator's assessment * clinical diagnosis of mild asthma during at least two months prior to screening visit * forced expiratory volume during the first second (fev1) \> 80% of predicted normal values at screening visit exclusion criteria: * endocrinological diseases including growth impairment or other chronic diseases * any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids
effectiveness of central oncology navigation and the use of an orn

Conditions: Cancer; Malignant Tumor

Summary: this health services interventional study investigates the effectiveness of central oncology navigation (soc ) alone and central oncology navigation with a new role called an "oncology research navigator (orn)" who is embedded in central oncology navigation cancer care delivery. this study will examine two patient cohorts: cohort 1 will enroll patients with new cancer appointments within genitourinary (gu) or thoracic cancers. these clinics have not yet implemented the central navigation program. participants will be enrolled pre- and post-implementation of the central oncology navigator within these cancer groups to evaluate the effectiveness of the central oncology navigator alone. the second cohort will enroll participants with new cancer appointments within gastrointestinal (gi), hematology, and breast cancer (clinics where the central navigation program was implemented). these individuals will be randomized to receive standard of care, which for these cancer types includes central oncology navigation or the intervention of an oncology research navigator in addition to soc. this intervention will involve baseline and biweekly follow-up for a total of 3 months. interactions with the orn will include facilitating participation in supportive care services and clinical trials. all participants will undergo baseline and follow-up patient-reported outcomes and data collection. the study will evaluate the impact of the central oncology navigation program alone, as well as the addition of the orn on patient quality of life, as well as enrollment into studies and participation in supportive care services. additional analyses will evaluate the impact of the central oncology navigation program on patient experience, patient activation, net promoter scores, and overall survival.


Eligibility criteria:
inclusion criteria: in order to participate in this study a subject must meet all of the eligibility criteria outlined below. * informed consent obtained to participate in the study and hipaa authorization for release of personal health information. * subject is willing and able to comply with study activities based on the judgement of the investigator. * age ≥ 18 years at the time of consent. * subject has a new patient appointment for cancer care at a unc medical center and a confirmed cancer diagnosis. exclusion criteria: * lack of internet access. * inability to understand the english language. * psychological or other disability resulting in the inability to provide informed consent.

Keywords: navigation
right ventricle lipid in pulmonary arterial hypertension (pah)

Conditions: Idiopathic Pulmonary Arterial Hypertension; Heritable Pulmonary Arterial Hypertension; Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

Summary: the investigators propose to study the relationship between right ventricle (rv) steatosis and rv function, exercise capacity, and outcomes in humans with pulmonary arterial hypertension (pah) and to identify potential drivers of lipid accumulation.

the investigators propose to test the hypothesis that abnormal lipid metabolism in pah leads to delivery of fatty acids in excess of rv oxidative capacity, resulting in steatosis and lipotoxicity. the objectives of the study are to: 1) define the relationships between rv steatosis, rv function, and exercise capacity; 2) identify mechanistic drivers of rv steatosis including bmpr2 expression and lipid metabolism; 3) examine lipid metabolism in pah skeletal muscle as a potential driver of reduced functional capacity. in aim 1 (clinical relevance) the investigators will measure rv and left ventricle (lv) lipid in participants with heritable, idiopathic, and scleroderma- associated pah. participants will undergo the 6-minute walk test, cardiopulmonary exercise testing, and will be followed for clinical events. a subgroup will undergo repeat mrs at four timepoints over three years to determine the natural history of steatosis. in aim 2 (mechanism), the investigators will perform metabolomic/lipidomic profiling of peripheral and coronary sinus plasma and measure bmpr2 expression to identify potential drivers of steatosis. in aim 3 (specificity), the investigators will perform mrs on skeletal muscle in aim 1 participants and matched healthy controls to clarify the systemic effects of lipid metabolic defects in pah.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * diagnosed with idiopathic, heritable, connective tissue disease-associated pah, associated pulmonary arterial hypertension (pah), or drug-or toxin-associated pah according to world health organization (who) consensus recommendations. * stable pah-specific medication regimen for three months prior to enrollment. adjustments in iv prostacyclin for side effect management are allowed. diuretic adjustments are permitted. * who functional class i-iii * ambulatory * able to have an mri/mrs, perform a 6mwd test, and cardiopulmonary exercise test exclusion criteria: * pregnancy * diagnosis of pah etiology other than idiopathic, heritable, connective tissue disease - associated pah or associated with drugs and toxins * who functional class iv heart failure * requirement for continuous oxygen * unable to have an mri/mrs, perform a 6mwd test, or cardiopulmonary exercise test. * patients with implanted/embedded ferromagnetic material that would preclude cardiac mri