Kornimate/medical-research-clean huggingface dataset:
a study of dasatinib in patients with imatinib resistant or intolerant chronic myeloid leukemia

Conditions: Chronic Myeloid Leukemia

Summary: the purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(cml) who are either resistant to or intolerant of imatinib mesylate.


Eligibility criteria:
inclusion criteria: * signed written informed consent * subjects with chronic phase chronic myeloid leukemia (cml) * subjects resistant/intolerant to imatinib * subjects presenting: 1. ecog performance status (ps) score 0-2 2. adequate hepatic function 3. adequate renal function 4. adequate lung function exclusion criteria: * concurrent malignancy other than cml * women who are pregnant or breastfeeding * concurrent pleural effusion * uncontrolled or significant cardiovascular disease * a serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy. * prior therapy with dasatinib * subjects with t315i and/or f317l bcr-abl point mutations

Keywords: chronic myeloid leukemia dasatinib chronic phase myeloid leukemia
effect of severe renal impairment on pharmacokinetics and metabolism of a single administration of licarbazepine

Conditions: Healthy

Summary: this study will assess the influence of severe renal impairment on the pharmacokinetics of licarbazepine and its glucuronide conjugate after single oral administration in healthy subjects and in subjects with stable impaired renal function.


Eligibility criteria:
inclusion criteria: * male and female subjects/patients from 18-60 years of age * body mass index (bmi) must be within the range of 18 and 30 kg/m². subjects/patients must weigh a minimum of 50 kg. * female subjects/patients must either have been surgically sterilized or hysterectomized at least 6 months prior to screening. * subject/patient must be able to provide written informed consent prior to study participation. exclusion criteria: * clinically significant abnormal laboratory values at the screening evaluation or at the baseline re-evaluation, for patients excluding those normally associated with severe degree of renal impairment or the primary cause of renal insufficiency. * use of any over-the-counter medications or herbal / natural supplements during 2 weeks prior to dosing. (acetaminophen is acceptable, but must be documented in the concomitant medications / non-drug therapies page of the crf). * participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. * donation or loss of 400 ml or more of blood within 8 weeks prior to dosing or other amount considered to compromise the health of the subject/patient if previous history of anemia exists. * significant acute illness within the two weeks prior to dosing. * history of any significant cardiovascular events (m.i., angioplasty, angina) within 6 months of study start. * a past medical history of clinically significant ecg abnormalities or a family history of a prolonged qt-interval syndrome. * history of hyponatremia. * history of seizures. * any surgical or medical condition which might significantly alter the absorption,distribution, metabolism or excretion of drugs other than renal impairment or which may jeopardize the subject/patient in case of participation in the study. the investigator should be guided by history of any of the following: inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding gastropathy (gastroparesis) or enteropathy major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection clinical evidence of pancreatic injury or pancreatitis * history of immunocompromise, including a positive hiv (elisa and western blot) test result. * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result . * history of drug or alcohol abuse within the 6 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations. other protocol-defined inclusion/exclusion criteria may apply

Keywords: open-label study, healthy subjects, stable impaired renal function, licarbazepine, pharmacokinetics, metabolism, safety.
immunogenicity and safety of subcutaneously-administered avonex (interferon beta-1a) in multiple sclerosis (ms) patients

Conditions: Multiple Sclerosis

Summary: the primary objective of the study was to evaluate the immunogenicity of avonex® (interferon beta-1a) 30 mcg when administered subcutaneously (sc) to interferon-naïve participants with relapsing multiple sclerosis. the secondary objective of this study was to evaluate the safety and tolerability of avonex® 30 mcg when administered sc to interferon-naïve subjects with relapsing ms.


Eligibility criteria:
inclusion criteria: * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations. * male or female aged 18- to 60-years-old, inclusive, at the time of informed consent. * must have a diagnosis of relapsing ms. * must have a screening expanded disability status scale (edss) score between 0 and 6.0, inclusive. * all male subjects and female participants of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last study dose of avonex. exclusion criteria: * history of severe allergic or anaphylactic reactions. * diagnosed with primary progressive, secondary progressive, or progressive relapsing ms. * known allergy to any component of the avonex formulation. * history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric renal, or other major disease. * subjects with history of malignant disease, including solid tumors and hematologic malignancies. * history of seizure disorder or unexplained blackouts or history of a seizure within 3 months prior to day 1. * history of suicidal ideation within 3 months prior to day 1 or an episode of severe depression within 3 months prior to day 1. severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy. * clinically significant abnormal electrocardiogram (ecg) values as determined by the investigator. * known history of, or a positive test result for, human immunodeficiency virus (hiv). * known history of, or a positive test result for hepatitis c virus. * abnormal screening blood tests exceeding any of the limits defined below: 1. alanine transaminase/serum glutamate pyruvate transaminase (alt/sgpt) greater than 2 times the upper limit of normal or aspartate transaminase/serum glutamic oxaloacetic transaminase or bilirubin. 2. total white blood cell count (wbc) \<3700 cells/mm 3. platelet count \<150,000 cells/mm 4. hemoglobin \<10 g/dl in female subjects; \<11 g/dl in male subjects 5. serum creatinine \>upper limit of normal (uln) 6. prothrombin time (pt) or activated partial thromboplastin time (aptt) \> 1.2\*uln

Keywords: multiple sclerosis - relapsing
individual patient compassionate use of nirogacestat

Conditions: Desmoid Tumor; NOTCH Gene Mutation Positive Tumors

Summary: this program is being offered on a patient by patient basis and will require company, institutional review board/independent ethics committee, and applicable competent authority approval.


Eligibility criteria:
inclusion criteria: * patient has a serious, debilitating or life-threatening medical condition that cannot be treated satisfactorily with an authorized medicinal product or other available standard treatment options, or all other treatment options have been exhausted. * patient does not qualify to participate in an ongoing clinical trial.

Keywords: desmoid tumor aggressive fibromatosis desmoid fibromatosis notch-positive tumors
effects of advertising on young children's perception of taste

Conditions: Obesity

Summary: to test whether young children's actual taste preferences are influenced by the natural marketing environment in which they live. to do so, we tested whether preschool children would like the taste of a food more if they thought it was from a heavily marketed source. we asked preschool children to taste identical foods in packaging from this heavily marketed source and plain packaging, and to tell us if they tasted the same or if one tasted better. we hypothesized that, even among a sample of 3-5 year olds participating in head start, a federally-sponsored preschool program for low-income families, young children would prefer the taste of foods perceived to be from the heavily marketed source.


Eligibility criteria:
inclusion criteria: * enrolled at participating head start sites exclusion criteria: * unable to complete the study procedures

Keywords: taste preschool children fast food
can blood panels provide early warning of bleeding in patients on ecmo?

Conditions: ECMO; Bleeding

Summary: this is a prospective, observational study of 60 adult patients anticoagulated with bivalirudin for extracorporeal membrane oxygenation (ecmo). the study aims to identify the most precise early warning blood test or panel of blood tests to predict bleeding in patients on bivalirudin/ecmo. the project will involve comparing currently used blood tests with an extended panel of coagulation and metabolic blood tests with the aim of early warning of impending bleeding to allow intervention in the form of adjusted bivalirudin dose, modification of other risk factors, or transfusion with hemostatic products targeted to documented coagulation test abnormalities.


Eligibility criteria:
inclusion criteria: * adults 18 - 70 years who are anticoagulation (ac) with bivalirudin and placed on ecmo for cardiac and/or respiratory failure. surgical and non-surgical patients will be included. exclusion criteria: * known pre-existing bleeding disorder (due to a factor deficiency that requires factor replacement, or platelet disorder), or a creatinine \> 2.0.
pd-1 in patients with advanced basal cell carcinoma who experienced progression of disease on hedgehog pathway inhibitor therapy, or were intolerant of prior hedgehog pathway inhibitor therapy

Conditions: Carcinoma, Basal Cell

Summary: the primary objective is to estimate the objective response rate (orr) for metastatic basal cell carcinoma (bcc) (group 1) and for unresectable locally advanced bcc (group 2) when treated with cemiplimab as a monotherapy


Eligibility criteria:
key inclusion criteria: * confirmed diagnosis of invasive bcc * progression of disease on hedgehog inhibitor (hhi) therapy or intolerance of prior hhi therapy * at least 1 measurable lesion * ≥18 years of age * hepatic function, renal function, bone marrow function in defined lab-value-ranges * anticipated life expectancy \>12 weeks * consent to provide archived tumor biopsy material (all patients) * group 2: consent to undergo research biopsies * group 2: must not be a candidate for radiation therapy or surgery * comply with study procedures and site visits * sign subject information sheet and informed consent form key exclusion criteria: * ongoing or recent significant autoimmune disease * prior treatment with specific pathway-blockers (pd-1/pd-l1) * prior treatment with immune-modulating agents within 28 days before cemiplimab * untreated brain metastasis that may be considered active * immunosuppressive corticosteroid doses (\>10mg prednisone) within 28 days prior to treatment with cemiplimab * active infections requiring therapy, including hiv, hepatitis * pneumonitis within the last 5 years * cancer treatment other than radiation therapy, including investigational or standard of care, within 30 days prior to treatment with cemiplimab * documented allergic reactions or similar to antibody treatments * concurrent malignancies other than bcc, other than those with negligible risk of metastases or death * any acute or chronic psychiatric problems * having received a solid organ transplantation * inability to undergo contrast radiological assessments * breastfeeding, pregnant, women of childbearing potential not using contraception note: other protocol-defined inclusion/exclusion criteria apply
multimodal analgesia in children and adolescents after the ravitch procedure and thoracotomy

Conditions: Pain, Postoperative; Surgery, Thoracic

Summary: the study was performed in patients aged 6-18 years after the ravitch procedure and thoracotomy. the primary aim of the study was to evaluate the efficacy and safety of pain control provided by the multimodal approach that involves the continuous infusion ropivacaine with fentanyl vs. bupivacaine with fentanyl through thoracic epidural catheter. secondary aims were to identify the determinants of acute post-operative pain at rest, during deep breathing and coughing.

the subjects were randomized to the ropivacaine/fentanyl (rf) or bupivacaine/fentanyl (bf) group. to perform a thoracic surgical procedure, all patients were premedicated with midazolam, and then, paracetamol, non-steroidal anti-inflammatory drugs, fentanyl, propofol, pancuronium or rocuronium (in children \< 10 years old) and suprane were used to introduce and maintain the anesthesia. thoracic epidural catheters were placed following induction of anesthesia and endotracheal intubation. intraoperative analgesia was introduced by a single dose of lidocaine 2% (2 mg/kg). then after 15 minutes, the patients from the rf group received ropivacaine 1% (1-3 mg/kg) and those from the bf group bupivacaine 0.5% (0.5-1 mg/kg). after 60 minutes 0.2% ropivacaine solution with fentanyl or 0.125% solution of bupivacaine with fentanyl was infused with the flow rate of 0.1 ml/kg/hr. depending on the allocation to the group, postoperative analgesia was continued either with 0.2% ropivacaine and fentanyl or 0.125% bupivacaine and fentanyl, based on the concentration and the flow rate described above. in addition, intravenous paracetamol was administered as standard every 6 hours (the maximum of 60 mg/kg daily) along with non steroidal anti-inflammatory drugs. in children \> 14 years of age, ketoprofen was injected at the dose of 1 mg/kg (the maximum of 200 mg daily) and in younger children ibuprofen (orally or rectally, up to 30 mg/kg daily) every 8 hours. metamizol was given as a "rescue drug" (20 mg/kg).

Eligibility criteria:
inclusion criteria: * elective thoracic surgery (thoracotomy or ravitch procedure); * analgesia: continuous thoracic epidural analgesia. exclusion criteria: * american society of anesthesiologists physical status \>iii; * history of chronic pain or preoperative opioid use; * oncological treatment; * impaired verbal communication; * removal of epidural catheter \<24 h postoperatively; * lack of postoperative chest drainage.

Keywords: multimodal analgesia thoracic epidural postoperative pain postoperative complications patient satisfaction
head position angles in children

Conditions: Healthy

Summary: inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. designing a ventilating device that could indicate how to open an upper airway correctly may be beneficial. the head of children is randomly placed in different head positions by one investigator. a ventilating mask is then pressed gently on the child's face followed by measurement of the head position angles and pulmonary function. this information could be utilised to optimise assisted ventilation of an unprotected upper airway in children.

ventilation during basic life support improves survival in cardiac arrest patients significantly. unfortunately, this is in contrast to the willingness of potential rescuers to perform mouth-to-mouth ventilation. for example, although healthcare professionals would perform mouth-to-mouth ventilation on a 4-year old drowned child in \>90% of cases, this likelihood would decrease to \~10% in the case of a young male unconscious patient in a san francisco public bus. possibly, lay rescuers would perform assisted ventilation more often if a simple ventilation device were available. however, both the willingness to perform assisted ventilation plus the ability to open and to maintain the airway patent are necessary to ensure efficient ventilation in an unconscious patient with an unprotected upper airway. since retention of skills after basic life support classes are notoriously low, a resuscitation tool should incorporate self-explanatory features to improve applicability, and to provide built-in safety. thus, an option could be to ensure an open airway by the use of a built-in indicator within a ventilating device to confirm correct head extension. one possible approach may be to determine head positions that make an open airway likely, and then extrapolate these angles to a scale that could be integrated into a ventilating device; however, safe head extension needs to be determined first to prevent harm. the purpose of this study is to determine head position angles reflecting neutral position and maximal extension in unconscious supine children in a first step to design a ventilating device to optimise ventilation of an unprotected upper airway.

Eligibility criteria:
inclusion criteria: * asa i and ii children, 1-10 years of age exclusion criteria: * facial deformity * pathological airway or cervical spine * bmi\>35 * history of gastric reflux

Keywords: airway airway obstruction mouth-to-mask resuscitation respiration artificial ventilation ventilation of an unprotected airway safety and efficiency of mask ventilation avoidance of stomach inflation
to evaluate the efficacy and safety in patients with primary hypercholesterolemia

Conditions: Primary Hypercholesterolemia

Summary: to evaluate the efficacy and safety of combination therapy of pitavastatin and ezetimibe versus monotherapy of pitavastatin in patients with primary hypercholesterolemia.

a multi-center, randomized, double-blinded, active-controlled, factorial design phase 3 clinical trial

Eligibility criteria:
inclusion criteria: * patients with primary hypercholesterolemia exclusion criteria: * the subject not meet the specified ldl-c level
clinical validation of the management process for renal anemia in maintenance hemodialysis patients

Conditions: Anemia of Chronic Kidney Disease

Summary: this test aims to verify that the management process of renal anemia in maintenance hemodialysis patients can improve the hemoglobin compliance rate better than that of anemia management by primary doctors, and promote the system at the grassroots level to guide primary doctors in anemia management and improve the management standard of renal anemia in maintenance hemodialysis patients through prospective randomized controlled trials. to improve the anemia compliance rate of maintenance hemodialysis patients, and to improve the basic doctors' grasp of the anemia management guidelines, consensus and standard operating procedures.


Eligibility criteria:
inclusion criteria: ① age over 18 years old; ② receive regular hemodialysis at least twice a week for at least 3 months, and have no plans to stop hemodialysis within 6 months since the start of the trial; ③ the patient voluntarily participated in this study. exclusion criteria: * patients who have planned to undergo kidney transplantation or terminate hemodialysis during the study period; ② previous history of bone marrow hematopoietic system diseases, such as combined myelodysplastic syndrome, multiple myeloma, and other diseases; ③ any known hereditary blood disease, such as thalassemia, sickle cell anemia, pure red blood cell aplasia, etc.; ④ active or chronic gastrointestinal bleeding; ⑤ there was a severe infection within one week prior to screening.
the at-reboa target trial

Conditions: Hemorrhage; Shock, Traumatic; Cardiac Arrest Due to Trauma; Polytrauma

Summary: temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. resuscitative endovascular balloon occlusion of the aorta (reboa) potentially provides a relatively quick means of achieving this temporary control. in the past years, studies have tried to evaluate the benefit for this method with conflicting results. the previous uk-reboa trial has not found any benefit in the intervention group and has even hinted at possible harm caused by the intervention. a major limitation of this study is the low number of interventions performed in participating trauma centres and the associated potentially insufficient experience with reboa. the aim of this study is to evaluate the effectiveness of reboa in a setting with already experienced providers.


Eligibility criteria:
inclusion criteria: * aged, or believed to be aged, 16 years or above * confirmed or suspected life-threatening torso or lower body trauma * thought to benefit from trauma resuscitation with reboa exclusion criteria: * penetrating chest trauma * known or suspected pregnancy at presentation * prehospital thoracotomy * severe burns injuries.
a study on the diagnostic value of the methacholine choline provocation test in the asthmatic population

Conditions: Asthma

Summary: this study was a multicenter, open, observational study and was divided into two stages; stage i study includes patients with suspected asthma to observe the diagnostic value and safety of methacholine choline provocation test. all patients clinically evaluated for bronchial provocation testing were included in the stage ii study to further validate the diagnostic value and cutoff value of the methacholine choline provocation test.

this study was a multicenter, open, observational study. the study was divided into two stages; the first stage of the study included a population with suspected asthma and performed a bronchial provocation test, and cumulative provocation dose when forced expiratory volume in one second (fev1) fell by 20% (pd20 ) data were recorded. subjects with positive excitation were treated as asthma for 3 months and treatment was considered effective to confirm the diagnosis of asthma. sensitivity, specificity, and reliability of the methacholine choline provocation test were calculated, and cutoff values were obtained by exploratory analysis based on pd20 values. all patients clinically evaluated for bronchial provocation testing were included in the stage ii study to further validate the diagnostic value and cutoff value of the methacholine choline provocation test.

Eligibility criteria:
inclusion criteria: stage i study: * clinically evaluated as suspected asthma but have not been previously diagnosed as asthma and require a bronchial provocation test * basal lung function fev1 ≥ 60% * meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations * not currently suffering from or accompanied by other respiratory diseases, including allergic rhinitis, chronic obstructive pulmonary disease, chronic bronchitis, etc. stage ii study: * basal lung function fev1 ≥ 60% * meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations exclusion criteria: * have had a fatal asthma attack, or have required mechanical ventilation for an asthma attack within the last 3 months * definite hypersensitivity reaction to inhaled stimulants or salbutamol or unexplained urticaria * severe impairment of basal pulmonary ventilation (fev1 \< 60% of expected value %, or \< 1 l in adults) * poor cooperation with basal pulmonary function tests that do not meet quality control requirements * other conditions that make a bronchial provocation test or pulmonary ventilation function test inappropriate (e.g., recent presence of severe cardiovascular disease, seizures, uncontrolled hypertension, etc.)

Keywords: asthma diagnosis methacholine choline provocation test