Kornimate/medical-research-clean huggingface dataset:
an investigational study to assess the effect of bms-986177 on aspirin in healthy participants

Conditions: Healthy Volunteers

Summary: the purpose of this study is to investigate the effect of taking multiple doses of bms-986177 when aspirin is taken once-daily. eligible participants will receive twice-daily doses of bms-986177 or placebo, with a once-daily dose of aspirin. the safety, tolerability and movement of bms-986177 into, through and out of the body (pharmacokinetics/pk) will be assessed, as will the effect of bms-986177 on the pk of aspirin.


Eligibility criteria:
inclusion criteria: * signed written consent form. * healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ecgs (electrocardiograms) and clinical laboratory determinations. * women participants must have documented proof they are not of childbearing potential. * males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with bms-986177, and for a total of 93 days after the last dose of bms-986177; and must be willing to refrain from sperm donation during this time. azoospermic males are exempt from contraceptive requirements. * normal renal function at screening (glomerula filtration rate ≥ 80 ml/min/1.73 m2. * body mass index (bmi) of 18.0 kg/m2 to 32.0 kg/m2 inclusive. exclusion criteria: * women who are of childbearing potential or breastfeeding. * any significant acute or chronic illness. * history of gastroesophageal reflux disease, dyspepsia, protracted nausea or chronic diarrhea. * history of upper gastrointestinal ulcer disease within 6 months or current symptomatic or recent gastrointestinal disease that could impact absorption of study treatment. * abnormal renal profile and/or hematuria (if male) within 3 months of study start. * history or evidence of abnormal bleeding and/or coagulation disorder and/or evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, or a history of spontaneous bleeding. * any major surgery within 4 weeks of study treatment administration or planned within 2 weeks after completion of the study. * donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks for plasma only). * blood transfusion within 3 months of study treatment administration. * use of tobacco- or nicotine-containing products (including, but not limited to cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges or nicotine gum) within 6 months prior to study treatment administration. * history of allergy to aspirin or related compounds. other protocol-defined inclusion/exclusion criteria could apply.

Keywords: healthy participants healthy subjects strokes
turkish version of hand-use-at-home questionnaire

Conditions: Cerebral Palsy; Brachial Plexus Palsy

Summary: to investigate the validity and reliability of the turkish version of parent-rated hand-use-at- home questionnaire (huh) in children with neonatal brachial plexus palsy or unilateral cerebral palsy.

cerebral palsy (cp) is defined as a permanent but non-progressive disorder group that affects the developing fetal or infantile brain, leading to impairment in movement and posture, thereby limiting physical activity and participation. the prevalence of cp in society is around 0.21%. in a study conducted in turkey, this ratio of 4.4 / 1000 live births has been reported. motor disorders in cp often are accompanied by sensory, perceptual, cognitive, communicative and behavioral problems and secondary musculoskeletal problems. obstetric brachial plexus (obp) injury is a common peripheral nerve injury in children. its incidence is reported between 0.42 and 5.1 per 1000 live births. as the primary mechanism of injury, it is accepted that traction or compression of all or part of the brachial plexus. in these patients, weakness in the upper extremity, long-term contractures, and difficulties in the use of the extremities occurs due to the damage of nerves. in both diseases, patients have difficulty in bimanual activities. many treatment methods focus on increasing the use of upper extremities of patients and ensuring their independence in daily life activities. there are many methods for evaluating the hand use performance of patients and the effectiveness of different treatment methods. however, these clinical evaluation methods often do not reflect the patient's performance at home, at school, in their daily living environments. the "hand use at home (huh)" questionnaire, which was created to be evaluated by parents, was developed in 2017 for measuring and evaluating the spontaneous use time of unilateral paretic children aged 3-10 in the affected hand and arm daily life activities. the validity and reliability of the questionnaire were determined in children with obstetric brachial plexus paralysis and unilateral sp. the purpose of this study; the translation of the huh questionnaire into turkish is to investigate its cultural adaptation, validity, and test-retest reliability.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of unilateral cerebral palsy or obstetric brachial plexus palsy * age between 3 - 10 * volunteer to study exclusion criteria: * having a visual disorder * history of botulinum toxin injection and surgery for upper extremity and hand in the last 6 months. * having robotic rehabilitation or intensive treatments such as constraint-induced movement therapy to increase upper extremity use in the last 6 months.

Keywords: brachial plexus unilateral cerebral palsy hand function child rehabilitation upper extremity hand use at home questionnaire
a multicentered prospective cohort study of chinese ibd patients

Conditions: Ulcerative Colitis; Crohn Disease

Summary: inflammatory bowel disease(ibd), including ulcerative colitis (uc) and crohn's disease (cd), is characterized by chronic and recurrent nonspecific intestinal inflammation with high disability rate. during the past few decades, the prevalence of ibd is increasing, especially in developing countries, which brings great burden to patients themselves and medical insurance. currently, biological medications such as tnfα inhibitors (infliximab, adalimumab, etc.), integrin receptor antagonist (vedolizumab) and interleukin 12/interleukin 23 inhibitor (ustekinumab) are commonly used in ibd treatment as well as traditional drugs such as glucocorticoid, immunosupressive agents and 5-aminosalicylic acid, and surgury. however, health-econimic analysis is lacking in chinese ibd patients and more research is needed for making treatment choice. meanwhile, the etiology, disease progression and prognosis prediction has not totally been clarified. the efficacy prediction model of vedolizumab and infliximab has been analyzed, whose prediction markers include level of albumin, smoking, surgery history, fistula, etc. however, no model has included predictors concerning disease pathway or pharmacological pathway in patients accepting different therapy. so a model to predict ibd progression and prognosis concerning pharmacological pathway is going to be explored.

the research is aimed at exploring the mode of ibd progression and predicting prognosis of different ibd patients so that treatment choice could be made to get better efficacy and decrease economic burden of patients and medical insurance. so blood and stool samples before and after treatment are collected to detect changes in gut microbiota and blood proteomics markers and explore the prediction model. also, inflammatory bowel disease questionnaire (ibdq) and eq5d3l will be collected and cost-utility analysis will be conducted.

Eligibility criteria:
inclusion criteria: * be diagnosed cd or uc according to chinese consensus on diagnosis and treatment in inflammatory bowel disease(2018, beijing) * willing to be followed up * intend to be treated by biological agents (vdz, ifx or ust) or conventional drugs (glucocoticoid±immunosupressive drugs±5-asa) exclusion criteria: * with complex complications
neuromuscular electrical stimulation in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to elucidate whether combination of usual pulmonary rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise capacity in patients affected by chronic obstructive pulmonary disease (copd).

neuromuscular electrical stimulation (nmes) has been extensively used as technique to improve muscle function in different areas of rehabilitation, however it seems to be more appropriate in critical care situation, while its use in more able patients is of uncertain benefit. in other words, nmes seems to be particularly effective in severely deconditioned and bed ridden patients. we therefore carried out a randomised trial to compare the efficacy of combination of nmes and pr (nm+pr) with combination of sham stimulation and pr (ss+pr) in a large population of moderately impaired copd patients. primary outcome was evaluation of effect of nmes on quadriceps strength and on exercise capacity. secondary outcome was evaluation of effect of nmes on symptoms (dyspnoea) and quality of life.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd * must be able to walk exclusion criteria: * previous or current diagnosis of chronic respiratory failure * a history of diseases other than copd, in particular neurological disease * need for treatment with systemic steroids during the rehabilitation period

Keywords: copd
comparative effectiveness of different surgical approaches for giant pituitary adenomas

Conditions: Surgery; Pituitary Adenoma

Summary: the surgical treatment strategy for giant invasive pituitary adenoma is one of the current hot spots in the field of clinical research on pituitary adenoma. a comprehensive literature search resulted in numerous previous studies to investigate the efficacy, advantages and disadvantages of different surgical options. a single approach (transnasal or craniotomy) is theoretically less invasive and has a shorter hospital stay for the patient, but may result in postoperative bleeding due to residual tumor and damage to the intracranial vessels adhering to the tumor. the advantage of the combined approach is that the tumor can be removed to the greatest extent possible. in addition, postoperative suprasellar hemorrhage can be prevented by careful hemostasis or intracranial drainage by the transcranial team if necessary. in this way, the risk of postoperative bleeding due to residual tumor can be significantly reduced. in some cases, waiting a few months after the initial surgery for a second-stage procedure may also be an option when the patient's condition does not allow for a combined access procedure, when the tumor is hard, or when the blood preparation is insufficient. however, staged surgery increases the financial burden on the patient, and local scar formation may make second-stage surgery more difficult and decrease the likelihood of endocrine remission of functional pituitary tumors. given the complexity of the treatment of giant invasive pituitary adenoma, there is a need to conduct studies comparing the combined transnasal cranial approach, the single access transnasal or cranial approach, and the staged approach simultaneously to assess whether the combined transnasal cranial approach is superior to the single access transnasal or cranial approach or the staged approach in improving the tumor resection rate in giant invasive pituitary adenoma.


Eligibility criteria:
inclusion criteria: * giant pituitary adenoma (\> 4cm in diameter) exclusion criteria: * most of the tumor were in the sellae, sphenoidal sinus or clivus. * patients with craniopharyngioma or meningioma.
investigation of popular recovery techniques for ultramarathon recovery

Conditions: Musculoskeletal Pain

Summary: the study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon.

the study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon. participants of the 2015 161-km western states endurance run were randomized to a 20-minute post-race intervention of massage, intermittent pneumatic compression or supine rest. each subject completed two 400 m runs at maximum speed before the race, and on days 3 and 5 after the race, and also provided muscle pain and soreness ratings and overall muscular fatigue scores before and for 7 days after the race.

Eligibility criteria:
inclusion criteria: * entry in the western states endurance run exclusion criteria: * failure to finish race
a study of fibrocaps in liver surgery in the netherlands

Conditions: Postoperative Hemorrhage

Summary: a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. the study will enroll 42 eligible subjects and be conducted at 4 sites in the netherlands.

this will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. subjects will be randomized in a 2:1 ratio to fibrocaps + gelfoam or gelfoam on the day of surgery. the fibrospray device will be used to apply fibrocaps to the target bleeding site. all investigators using the fibrospray device will be trained on the correct and safe set-up and use of fibrocaps and the fibrospray device prior to participating in this clinical trial.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years of age 2. subjects who are able and willing to provide written and signed informed consent 3. willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits 4. has a life expectancy of at least one year 5. presence of mild or moderate bleeding/oozing and control by conventional surgical techniques including but not limited to suture, ligature, and cautery is ineffective or impractical exclusion criteria: 1. pregnant or lactating women 2. has a known intolerance to blood products or to fibrocaps components 3. unwilling to receive human blood products 4. subject has a known allergy to porcine gelatin 5. has a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol 6. currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery, or is planning participation in another clinical trial during the 4 weeks after surgery 7. has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator 8. platelets(plt) \< 100 x109 plt/l during screening 9. activated partial thromboplastin time (aptt) \> 100 seconds during screening 10. international normalized ratio (inr) \> 2.5 during screening
effect mindfulness training on attention, hyperactivity and emotion regulation among children with adhd:

Conditions: A

Summary: mindfulness training is a promising form of training for children with adhd, as it focuses on attention and has gained empirical support as a complementary or alternative intervention. it involves increasing awareness and nonjudgmental observation of present-moment experiences while reducing automatic responding

training to sustain focus on present-moment experiences and gently shifting attention back to the meditation object when the mind drifts (bishop, et al., 2004). mindfulness meditation is a relatively new approach for reducing stress and emotion regulation difficulties among children. while researching the efficacy of mindfulness training in children is a new domain, existing evidence suggests that it has positive effects on psychological well-being, pain management, emotion dysregulation, negative behaviors, and cognitive/executive functions and attention (evans et al., 2018; zhang, díaz-román, \& cortese,2018). nurses have an important role in caring for children with adhd, particularly in the context of mindfulness-based interventions. they can provide education and support to both parents and children regarding the benefits of mindfulness practice and can help implement mindfulness programs in clinical and community settings.

Eligibility criteria:
inclusion criteria: * age from 10-18 years old * diagnosed with adhd exclusion criteria: * age less than 10

Keywords: mindfulness adhd
safety and efficacy study of a new chemotherapy agent to treat small cell lung cancer

Conditions: Small Cell Lung Carcinoma

Summary: the purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany.bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven small-cell lung cancer (sclc) * stage of extensive disease defined by the presence of distant metastases * at least 1 unidimensionally measureable lesion * who performance status 0 to 1 * no previous sclc-related chemotherapy * no previous sclc-related surgery * no previous radiotherapy (excepting for brain metastasis) * adequate function of major organs and systems * nervous system * no grade 2 or greater peripheral neuropathy * cardiovascular: * no symptomatic congestive heart failure * no unstable angina pectoris * no arrythmia needing continuous treatment * no other uncontrolled concurrent illness exclusion criteria: * superior vena cava syndrome or obstruction of any vital structure * untreated malignant hypercalcemia * pleural effusion as the only manifestation of disease * extensive disease amenable to radiation therapy * symptomatic brain metastases requiring whole brain irradiation * any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix

Keywords: sagopilone epothilone sclc small cell lung cancer lung cancer
differences in trends malignant germ cell tumors in males and females: a seer population-based study

Conditions: Cancer

Summary: differences in 30-year trends in incidence and survival for malignant germ cell tumors in males and females.

differences in 30-year trends in incidence and survival for malignant germ cell tumors in males and females: a seer population-based study.

Eligibility criteria:
inclusion criteria: * survival for malignant germ cell tumors in males and females.
pharmacodynamic evaluation of antiplatelet effect of swallowing versus chewing ticagrelor in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the study aims to determine the pharmacodynamic performance in the first hour measured with verifynow, of the conventional ticagrelor loaded dose versus chewed ticagrelor in patients with acute coronary syndrome treated with percutaneous coronary intervention


Eligibility criteria:
inclusion criteria: * all patients presenting to the emergency department with acute coronary syndrome for percutaneous coronary intervention exclusion criteria: * age \<18 years * known coagulopathy, bleeding diathesis, or active bleeding * history of recent gastrointestinal or genitourinary bleeding within 2 months * previous therapy with clopidogrel, prasugrel, or ticagrelor * previous treatment with glycoprotein iib/iiia inhibitors or during interventional procedure * major surgery within 6 weeks * history of intracranial bleeding or intracraneal neoplasm * suspected aortic dissection * chronic obstructive pulmonary disease * severe hemodynamic instability or cardiogenic shock * resuscitated cardiac arrest * use of vitamin k anticoagulants or novel oral anticoagulants (noacs) within 7 days * life expectancy \<1 year * known severe liver or renal disease, gfr estimated by ckd-epi \<30 ml/min/1.73 m2 * known hiv treatment * hemoglobin \<10 g/dl * platelet count \<100,000/l * pregnancy * known allergy to ticagrelor * refusal to sign informed consent

Keywords: ticagrelor platelet aggregation inhibitors verifynow acute coronary syndrome
development of consciousness measure and monitor device based on electroencephalography

Conditions: Electroencephalography; Consciousness

Summary: this study aims to develop a consciousness measuring and monitoring device using a single-channel electroencephalogram (eeg).

study objectives: 1. to develop a single-channel eeg database of emergency department (ed) patients with altered mental status. 2. to analyze single-channel eeg recordings and extract significant parameters. 3. to develop a consciousness prediction model using single-channel eeg. study design: observational multicenter study in 6 tertiary hospital eds in korea (seoul national university hospital, seoul metropolitan government seoul national university boramae medical center, kyungpook national university hospital, chungbuk national university hospital, chonnam national university hospital, korea university ansan hospital). the investigators will obtain single-channel eeg data of ed patients with altered consciousness and develop a prospective database of the data. with the constructed database, a consciousness prediction model using single-channel eeg will be developed. the prediction performance of the developed model using area under receiver operating characteristic curve (auc) will be evaluated.

Eligibility criteria:
inclusion criteria: * adult ed patients with a decreased level of consciousness (verbal, pain, or unresponsive using the avpu scale, and a gcs-e score of less than 4) who have stayed at the ed for less than 12 hours at the time of enrollment. exclusion criteria: * patients with the difficulty of applying eeg due to head trauma or skull deformities. * patients for whom standard treatment may be significantly delayed by applying the eeg device. * patients with a guardian who do not agree to enroll in this study.
serum biomarker of plaque vulnerability and contrast ultrasound of carotid artery

Conditions: Intraplaque Neovascularization Evaluated by Carotid Enhanced Ultrasound Well Reflect the Plaque Vulnerability

Summary: no serum biomarker has qualified for clinical use until now. however several biomarkers, especially markers of inflammatory or proteolytic activity seem to promising in the identification of vulnerable plaques. moreover, recent study confirmed that contrast-enhanced ultrasound imaging(ceus) can visualize intraplaque neovascularization and represent the plaque vulnerability. in this study we try to identify indicators through analysis of the relationship between plaque neovascularization seen by ceus and well known biomarkers such as serum matrix metalloproteinase(mmp)-2, mmp-9, cathepsin family(l,s,v), cystatin c, lipoprotein phospholipase a2, and hs-crp


Eligibility criteria:
inclusion criteria: * patients with carotid plaques size more than 2mm by carotid ultrasound exclusion criteria: * known allergy to albumin, or to the ultrasound contrast agent * the patients with history of carotid endarterectomy and carotid stent * acute myocardial infarction, cardiogenic shock * connective tissue disease and malignancy * creatinine clearance lower than 30ml/min and the history of dialysis

Keywords: biomarker carotid enhanced ultrasound intraplaque neovascularization