Kornimate/medical-research-clean huggingface dataset:
vinorelbine for recurrent alcl-2017

Conditions: Anaplastic Large Cell Lymphoma; Vinorelbine

Summary: the purpose of this study is to assess the efficiency and safety of vinorelbine in the treatment of relapsed / advanced alcl in children and adolescents.

anaplastic large cell lymphoma (alcl) is a rare non-hodgkin's lymphoma, around 30% patients would get relapse. vinorelbine(navelbine) is a third-line treatment option for hodgkin's disease(hd) after transplantation failed, while both hd and alcl express cd30. when alcl recurred, vinblastine monotherapy was used and the 5-year efs up to 30%, 5-year os up to 60%. in china vinblastine is unavailable. vinorelbine is very similar to vinblastine in molecular formula, and is available in china. from november 2016 to march 2017, two patients with recurrent alcl were recruited in the department of hematology and oncology, shanghai children's medical center. they received vinorelbine monotherapy and achieved clinical remission (pet cr) at 8 weeks. one patient with bone marrow recurrence showed negative alk / npm by pcr . based on this, the investigators will expand the sample to further investigate the therapeutic efficiency and safety of vinorelbine in children and adolescents with alcl.

Eligibility criteria:
inclusion criteria: children and adolescents with a clear diagnosis of recurrent / progressive alcl at shanghai children's medical center or other centers since september 2017 include: diagnosed as alcl, already received first-line treatment, but get disease progression; after receiving alcl treatment has got cr then diagnosed relapse, need for pathological diagnosis. exclusion criteria: patients with other systemic diseases, severe infections or critically illness.

Keywords: anaplastic large cell lymphoma recurrent childhood adolescent treatment
delivering geospatial intelligence to health care providers

Conditions: Overweight

Summary: physician counseling for physical activity, dental services, and academic support services such as tutoring could be improved through physician knowledge of local community resources and physician counseling directing patients to such services that are near the patient's residential address. this study will test the hypothesis that an electronic medical record enhanced with geographic information systems can improved physician counseling for physical activity, dental services, and academic support services by identifying services that are near the patient's residential address and informing md's of such info at the point of care.


Eligibility criteria:
inclusion criteria: * referrals to three community resources will be studied: dentists (children older than 1 year), after school tutoring services (children older than 7 years), and physical education programs (children older than 5 years). exclusion criteria: * inability of parent to complete data collection instruments spoken (via telephone survey) or written in english or spanish. * inability to participate in community based physical activity programs due to health related condition

Keywords: obesity overweight dental caries school problems school failure child bmi > 85th percentile needing dental preventive services needing academic support for school problems
everolimus related pneumonitis in mbc

Conditions: Everolimus; Pneumonitis

Summary: to study the drug-related pneumonitis during mtor inhibitor therapy in patients with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. postmenopausal woman (or premenopausal women treated with lhrha) diagnosed with hr+，her2- metastatic breast cancer 2. treated with everolimus for at least one month in metastatic setting 3. with baseline and at least one follow-up chest ct during everolimus therapy. 4. complete medical history exclusion criteria: 1. incomplete medical history 2. radiographic imaging unavailable
fluvoxamine maleate in the treatment of depression/depressive state : a post-marketing clinical study in children and adolescents

Conditions: Major Depressive Disorder

Summary: this study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the treatment of children and adolescents with depression or depressive state


Eligibility criteria:
inclusion criteria have a minimum total score of 18 on the jsigh-d, weight is within the standard weight ± 2s.d. based on the standard weight for each age in the school health statistical survey exclusion criteria have the following predominant psychiatric diagnosis -schizophrenia have previously been treated with fluvoxamine maleate

Keywords: fluvoxamine maleate depression children and adolescents
rotational thromboelstometry (rotem) change_colloid_total hip replacement arthroplasty

Conditions: Avascular Necrosis of Hip; Total Hip Replacement Arthroplasty

Summary: the investigators administered different kinds of colloids before transfusion of red blood cell to patient undergoing total hip replacement arthroplasty. the investigators will compare the differences of changes in rotational thromboelastometry (rotem) data among them.


Eligibility criteria:
inclusion criteria: * patients diagnosed as avascular necrosis of hip and undergoing total hip replacement arthroplasty exclusion criteria: * hematologic disease * anticoagulant medication * preoperative hemoglobin \< 10 g/dl * renal disease * pulmonary disease (pulmonary edema, effusion) * cardiovascular disease (coronary heart disease, congestive heart failure)
integrated eye tracking and neural monitoring for enhanced assessment of mild tbi: primary study

Conditions: Mild Traumatic Brain Injury

Summary: this study was conducted to develop and validate integrated eye tracking and eeg measures for assessment of mild traumatic brain injury.


Eligibility criteria:
inclusion criteria: * age 18 -55, ability to use left and right hands and right foot to complete cognitive and motor tasks without adaptive equipment, and fluent in english exclusion criteria: * history of severe tbi, history of neurological illness unrelated to tbi, vision problems that are uncorrected by contacts or glasses, history of psychotic disorder, or current homicidal or suicidal ideation or intent

Keywords: traumatic brain injury, concussion, eye tracking, eeg, fmri, dti, neurocognition
weight and metabolic effects of an almond enriched hypocaloric, low fat diet on overweight and obese persons

Conditions: Obesity; Metabolic Syndrome X; Hyperlipidemia; Hypertension

Summary: the purpose of this trial is to study the safety, tolerability and efficacy of an almond enriched hypocaloric diet on weight loss and weight maintenance, as well as on established and emerging cardiovascular risk factors in approximately 112 overweight and obese persons.

a randomized, non-blinded, controlled clinical trial using a parallel design of a hypocaloric, low fat (\<30% energy from fat) diet with or without 2 oz of almonds over 18 months. interim analyses will be conducted at 3, 6, 9 and 12 months. the study will be divided into 3 phases. phase 1 (months 0-6) will be an active, intensive weight loss phase. during phase 1, all subjects will meet once a week in the evening for 1.5 hours. phase 2 (months 6-12) will be a less intensive weight loss phase. during phase 2 groups will meet every other week in the evening for 1.5 hours. the last phase will be the weight maintenance phase or phase 3 (months 12-18).

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 27 but \<40 * 18-75 years of age * men and non-pregnant or lactating women * subjects must be willing to comply with all study-related procedures exclusion criteria: * uncontrolled hypertension * diabetes or use of anti-hyperglycemic medication * dyslipidemia requiring prescription drug therapy as defined by ncep atpiii guidelines at screening * known allergy or sensitivity to nuts * known atherosclerotic cardiovascular disease * history of congestive heart failure * history of a non-skin malignancy within the previous 5 years * any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition * history of being hiv positive * history of alcohol or drug abuse * weight-loss inducing medications or dietary supplements within 3 months prior to enrollment. * weight loss \> 5 kg during the last 6 months * participation in an investigational drug study within 6 weeks prior to screening * serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study

Keywords: obesity, metabolic syndrome, bmi
study to evaluate the interaction between aspirin and nexium

Conditions: Healthy Volunteers

Summary: the purpose of this study is to assess the interaction between aspirin and nexium in healthy volunteers.


Eligibility criteria:
inclusion criteria: * provision informed consent prior to any study specific procedures. * healthy male and female subjects aged 18 to 75 years with suitable veins for cannulation or repeated vein puncture. * healthy female subjects must be of non-childbearing potential (post-menopausal, had a hysterectomy and/or bilateral oophorectomy) or be of childbearing potential and have a negative serum hcg pregnancy test during screening and be using of the following methods of birth control: * continuously practice abstinence during screening and throughout the duration of the study * clinically accepted contraception as described under item 7 of section 5.1 and on hormonal contraceptives. * have a body mass index (bmi) between 19 and 30 kg/m2 * no clinically significant abnormal findings as judged by the investigator on enrollment physical exam. exclusion criteria: * involvement in the planning and/or conduct of the study (applies to both astrazeneca staff and/or staff at the study site) * previous enrolment or randomisation in the present study. * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study e.g. history of any bleeding disorder, excessive bruising or ongoing or history of liver disease * history or presence of clinically significant gastrointestinal e.e. gi ulcer, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs. * any clinically significant illness within 4 weeks of the first administration of investigational product.

Keywords: nexium aspirin peptic ulcers pharmacodynamic (pd) esomoeprazole
novel compositions for treating or preventing dermal disorders

Conditions: Dermal Atrophy

Summary: this trial examines the impact of a topical formulation of rapamycin on dermal thickness and senescence.

aging of the skin is the most prominent feature of the aging process, being caused by multiple factors such as intrinsic aging process and uv light exposure. dermal atrophy, also called skin atrophy or atrophy, is a disorder manifesting thinning or depression of skin due to reduction of underlying tissue. dermal atrophy is a major clinical problem in the elderly population. loss of dermal integrity leads to increased fragility of the skin and precludes the use of intravenous lines in many cases. skin tears are a significant concern in elderly individuals directly related to dermal atrophy. impairment in wound healing is an important clinical sequelae of reduced dermal integrity leading to an increase in the number of the infections and complications following injury. seborrheic keratosis, which comprise focal areas of epidermal thickening, can occur, possibly representing a response to damage. it has been estimated that 100% of individuals over 50 years of age harbor at least one of these lesion. there is not treatment for dermal atrophy and seborrheic keritoses require excision if they become large enough to cause discomfort or distress. therefore, there is a need to develop novel compositions and methods for treating or preventing certain age-related dermal conditions. rapamycin is an fda approved drug that has been in clinical use for over 15 years. systemic application of rapamycin has been a central part of immuno suppressive therapy for transplant patients in combination with other immuno suppressants. the safety record for systemic use of rapamycin is excellent and few side effects are associated with extended use.

Eligibility criteria:
inclusion criteria: * healthy adults exclusion criteria: * individuals with any chronic disease will be excluded from the study including those with the following conditions: * diabetes * any type of malignancy * severe coronary artery disease * hiv infection * hepatitis c or b * any sign of skin disorder or disease aside from normal aging, dermal atrophy, or seborrheic keratoses. * premenopausal women will be excluded * patients taking the following medications will be excluded: * cyclosporin * calcium channel blockers: diltiazem, verapamil * antifungal agents e.g. clotrimazole, fluconazole, itraconazole * antibiotics: clarithromycin, erythromycin, rifampicin * anticonvulsants: carbamazepine, phenobarbitone, phenytoin * antinausea drugs e.g. metoclopramide * other drugs e.g. danazol, protease inhibitors (e.g. for hiv and hepatitis c including ritonavir, indinavir, boceprevir, and telaprevir) * grapefruit juice * st john's wort (hypericum perforatum, hypericin)
measurement of glucose metabolism in humans: effect of recurrent hypoglycemia on hypothalamic gaba

Conditions: Type 1 Diabetes; Healthy

Summary: you are invited to participate in a study designed to investigate the effects of diabetes mellitus, high and low glucose, and high blood insulin on the brain. you were selected as a possible participant because you fit into one of the following categories. a) you are either healthy and competent, are not pregnant and you have no known medical disease and therefore your glucose metabolism will be typical of a normal person, or b) you have diabetes.

glucose is a major fuel for most organs in the human body, particularly the brain. how and where the body uses glucose is regulated by a number of hormones, for instance insulin and glucagon. in a number of diseases, in particular diabetes mellitus, the glucose supply to the brain may be different than normal, which may be a cause for reduced glucose awareness. the purpose of this study is to determine the effects of altered glucose metabolism on the brain. for example, patients with long duration diabetes mellitus lose their ability to secrete the hormones necessary to protect them against hypoglycemia, which may be due to alterations in glucose availability to the human brain. to measure these effects, we will use intravenous infusions of glucose and insulin.

Eligibility criteria:
inclusion criteria: * well controlled type 1 diabetes (hemoglobin a1c \<7.5%) * age 18-65 * healthy controls exclusion criteria: * history of stroke, seizures, neurosurgical procedures, or arrhythmias * use of drugs that can alter gaba metabolism (such as benzodiazepines). * subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs and the absence of metallic substances in their body.
a clinical observation on electrophysiology in headache patients with myofascial trigger points

Conditions: Myofascial Trigger Points

Summary: through an observational, cross-sectional study, muscle activity was compared among 21 subjects with episodic headache, 17 subjects with chronic headache and 17 age-matched healthy controls. muscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (mtrps) in the frontal, temporal, sternocleidomastoid (scm), splenius capitis, splenius cervicis and trapezius of each subject. headache characteristics (intensity, frequency and duration), mcgill pain questionnaire (mpq) and digital span (ds) scales were secondary outcomes. the correlation between muscle activity and headache characteristics was also analyzed. this study provides preliminary evidence of the relationship between muscle and the chronicity of headache.


Eligibility criteria:
inclusion criteria: 1. have at least one onset of headache in the last week, 2. aged between 18-65 years, 3. no special treatment or invasive test on pericranial muscles in the last month, and no painkillers or muscle relaxants in the last week. exclusion criteria: 1. history of surgery, trauma, tumor and spinal disease affecting the head and neck, 2. being unable to cooperate with inspection and questionnaires for any reason (severe systemic disease, bleeder, communication barriers and so on), 3. people with definite mental disorders such as anxiety and depression.
descriptive observational study of patient-performed pre-oxygenation

Conditions: Anesthesia; ASA Physical Status I; ASA Physical Status II

Summary: the aim of this research would be to determine the efficacy and effects of preoxygenation when performed by the patient (mask held by the patient). this is the concept of "self-preoxygenation".

pre-oxygenation is a fundamental element of the induction sequence in anesthesia, described and recommended since 1955. numerous studies have examined and compared the various techniques for implementing this procedure in terms of duration, objectives, equipment, patient characteristics and conditions. none of them specifies who should hold the mask when carrying out this recommendation. in everyday practice, patients are often asked to hold the mask themselves. a preliminary survey showed that 86% of patients are offered this option. the professionals questioned cited relational reasons (83%) above all, but also organizational reasons (43%).

Eligibility criteria:
inclusion criteria: * patient undergoing scheduled surgery with general anesthesia * patient classified asa i or ii * patient understanding and speaking french * patient informed of the study and not opposed to it * decision to have preoxygenation carried out by the patient. exclusion criteria: * patients with grade ii or iii obesity (bmi\>35) * patient with at least one respiratory comorbidity * smoking patient * pregnant patients * patient with an allergy to one of the mask's components * patient with cognitive impairment or known comprehension difficulties * patient under guardianship or curatorship * patient not affiliated to health care system

Keywords: preoxygenation general anesthesia adult preoperative anxiety
qualitative analysis of interviews between pharmacist and elderly patients treated with antithrombotics for an ischemic stroke.

Conditions: Stroke

Summary: cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. there are brakes and levers of medication adherence in the context of secondary prevention treatment in stroke.

cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. the probability of stroke recurrence is high: about 25% the first year , and 30 to 40% in the 5 years following the stroke. recurrent strokes are responsible for significant disability, institutionalization, major neurocognitive disorders, and death. in order to reduce the risk of stroke recurrence, multiple secondary prevention strategies have demonstrated their effectiveness, such as the prescription of drugs (in particular statins and antithrombotics), the establishment of a balanced diet, the practice of an activity physical, or even tobacco addiction. however, the effectiveness of these strategies is optimal if and only if patients adhere to them. in addition, previous studies have focused on the brakes and levers of medication adherence in the context of secondary prevention treatment in stroke. in elderly patients, other obstacles could have been identified by specific studies, such as cognitive, sensory, functional disorders or even isolation.

Eligibility criteria:
inclusion criteria: * patients aged 65 and over * patients hospitalized for an ischemic stroke or a recurrence of ischemic stroke, already being treated with an antithrombotic treatment (antiplatelet agent or anticoagulant ) prior to the stroke * patients living at home and with a plan to return home. * patients who did not object to the study and who gave their consent for the recording of the interview exclusion criteria: * patients with cognitive disorders or stroke sequelae that do not allow a semi-directive interview to be carried out (at medical discretion). * non-french speaking patients

Keywords: qualitative study semi-structured interview antithrombotic stroke medication adherence
drug interaction & methadone & buprenorphine

Conditions: Hepatitis C

Summary: the purpose of this study is to assess the effects of steady state dcv/asv/bms-791325 fixed dose combination (fdc) + 75mg bms-791325 on the pharmacokinetics (pk) of methadone in subjects with the stable dose of methadone and on the pk of buprenorphine in subjects with the stable dose of buprenorphine.

ind number: 101,943 primary purpose: other: phase 1 clinical pharmacology drug interaction study in healthy subjects

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subject must be on stable methadone or buprenorphine regimens for at least 28 days prior to screening exclusion criteria: * subjects must be healthy except for history of methadone or buprenorphine treatment regimens * prior exposure to dcv, asv or bms-791325 within 3 months of screening or any other investigational drug or placebo within 4 weeks of study drug administration