Kornimate/medical-research-clean huggingface dataset:
children's susceptibility to enterovirus 71 in different areas of taiwan

Conditions: Enterovirus 71, Host Genetics, Social, Behavior, Environmental Factors

Summary: ev71 has caused large epidemics with lots of fatal cases and cases with sequelae. however, the clinical syndromes and severity of the same ev71 strain are very diverse, ranging from asymptomatic (71%) to fatal (0.05%) disease, and the pathogenesis remains unknown. in addition, the severe or fatal case incidence varies significantly differently in different areas of taiwan. although some viral virulence studies were performed, no clear viral virulence factor has been found. therefore, host factors may be important to the clinical outcomes of ev71 infections. in addition, there were significantly different incidences of severe or fatal cases in different areas of taiwan, for example, significantly more fatal or severe cases occurred in the central or southern taiwan in comparison with in northern taiwan. whether this is related to host factors, social, behavioral or environmental factors remains unanswered. to find the most important factors associated with ev71 susceptibility, a thorough study involving genetics, social, behavioral or environmental factors among different areas of taiwan is warranted and the findings will provide future prevention of ev71 and give help on early precaution and treatment of ev71.

the specific aims are to find factors associated with different severe/fatal incidences in different areas of taiwan. we will do 1. comparison of gene variants in ev71 cases with different severity and normal children in different areas of taiwan to find susceptible genes and genetic polymorphism related to the clinical outcomes 2. social, behavioral and environmental factors related to ev71 infections in different areas of taiwan

Eligibility criteria:
inclusion criteria: - enterovirus type 71 exclusion criteria: - not enterovirus type 71

Keywords: enterovirus 71, host genetics, social, behavior, environmental factors
study of the osteoprotector effects of a milk product based on anthocyans and enriched in calcium and vitamin d

Conditions: Osteoporosis

Summary: we hypothesize that anthocyans with calcium and vitamin d have a positive effect on bone reshaping in menopausal women.


Eligibility criteria:
inclusion criteria: * women * aged between 50 and 65 years * between 1 and 5 years menopause * imc between 19 and 30 kg/m² exclusion criteria: * medical treatment for bone metabolism * vitamin d not including in the range of 20nmoles\<25(oh)\<100nmoles/l * vegan and vegetarian diet * regular consumption of food supplementary benefits * lactose intolerance * while dieting

Keywords: osteoporosis prevention
stereotactic body radiotherapy (sbrt) for oligoprogressive breast cancer

Conditions: Metastatic Breast Cancer; Oligoprogression

Summary: recent advances in systemic therapy have facilitated improved progression-free survival (pfs) and treatment tolerability in metastatic breast cancer patients (mbc). oligoprogression (op) refers to progression limited to five or fewer sites in otherwise controlled systemic disease on a drug therapy. stereotactic body radiotherapy (sbrt) has the potential to locally ablate resistant op lesions that develop on a systemic treatment, and may consequently delay the need for change in drug therapy, delay time to chemotherapy and prolong pfs. this is a phase ii trial of sbrt plus continuation of current systemic therapy line for op mbc patients, to determine rate of delay of change in systemic therapy of at six months. pfs, time to chemotherapy and quality of life will also be assessed.


Eligibility criteria:
inclusion criteria: 1. diagnosis of progressive metastatic breast cancer on first line systemic therapy, including either hormone receptor positive, her-2 negative (hr+/her2-) on endocrine therapy + cdk4/6 inhibitor or her-2 positive (hormone receptor positive or negative /her2+) on her2-targeted therapy regimens. 2. progressive disease limited to "oligoprogression", defined as progression of 5 or fewer extra-cranial lesions with otherwise controlled systemic disease on current line of systemic therapy. 3. patients must have previously controlled disease for at least six months on current systemic therapy 4. deemed a candidate for stereotactic body radiotherapy (sbrt) to all op lesions exclusion criteria: 1. requires change in systemic therapy line at the time of op as determined by medical oncologist; 2. progression on 2nd line or subsequent lines of therapy 3. lacks ct or bone scan imaging within previous 45 days; 4. progression in \>3 sites in the liver or lung; 5. hormone positive disease on endocrine therapy only at time of enrollment; 6. previous radiotherapy to same site or vicinity preventing definitive sbrt (e.g. within 5 cm); 7. lesions deemed not amenable to sbrt due to large size or location; 8. unacceptable fracture risk according to clinician judgement for bone lesions; 9. brain metastasis or spinal cord compression; 10. history of major radiosensitivity syndrome or contraindications to radiotherapy.
antimalarial drug susceptibility and molecular characterization of plasmodium vivax isolates in vietnam

Conditions: Plasmodium Vivax Malaria

Summary: this is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in viet nam. there are two important drugs used in viet nam for treating vivax malaria, chloroquine and artemisinin. sometimes, when medicines are used for many years they become less effective at treating a disease, especially when they are not used at adequate doses according to national guidelines or when counterfeit drugs are available in the market. the purpose of this study is to check that chloroquine and artemisinin, are still effective for patients in viet nam. participants in this study will be treated with either dihydroartemisinin-piperaquine (dha-ppq) or chloroquine (cq) for 3 days. both drugs are recommended by the national guidelines to treat vivax malaria. the investigators would like to know if both of these treatments are equally effective so half of the patients in the study will be treated with dha-ppq and the other half will be treated with cq. this way the investigators can compare the drugs to find out if one is better than the other. participants will be followed for 3 days in hospital, then regularly by follow-up visits until the 63rd day. tests will be done to determine the amount of drug and malaria parasites in the participant's body and how the blood cells react to the malaria. the parasite will be tested to determine what type it is and how it reacts to the treatment. the results of the study will be used to inform malaria treatment guidelines in viet nam.


Eligibility criteria:
inclusion criteria: * age \> 3 years; * mono-infection with p. vivax, parasitemia \> 250/µl asexual forms for in vivo and \>8000 asexual parasites/µl blood for in vitro testing; * presence of axillary or tympanic temperature ≥ 37.5 °c or history of fever during the past 24 h; * ability to swallow oral medication; * ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; * informed consent/assent exclusion criteria: * presence of general danger signs or severe malaria according to the definitions of who (2000); * mixed infection with p.falciparum and p.vivax of other plasmodium species; * presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, hiv/aids); * regular medication, which may interfere with antimalarial pharmacokinetics; * received antimalarial drugs in the previous 48 hours; * history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); * splenectomy; * first trimester of pregnancy.
laryngeal mask airway (lma) for surfactant administration in neonates

Conditions: Respiratory Distress Syndrome

Summary: the primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (rds) on nasal continuous positive airway pressure (ncpap) who receive surfactant via a laryngeal mask airway (lma) with those who are maintained on ncpap and do not receive surfactant.

secondary outcomes were total number of hours on mechanical ventilation, cpap and supplemental oxygen during the first 7 days of life and for the entire hospitalization. other secondary outcomes were number of surfactant doses, incidence of pulmonary air leak, survival until discharge, chronic lung disease (defined as need for oxygen at 36 weeks pma), oxygen requirement at discharge, severe intraventricular hemorrhage (grade 3/4), and periventricular leukomalacia.

Eligibility criteria:
inclusion criteria: * gestational age at time of enrollment 28 0/7 to 35 6/7 weeks postmenstrual age * age less than or equal to 36 hours old * on ncpap 6 with supplemental oxygen requirement (fi02 greater than or equal to 30%) for greater than or equal to 30 minutes (to maintain sa02 between 88-92%) * chest radiograph and clinical presentation consistent with respiratory distress syndrome (tachypnea, retractions, nasal flaring, and/or grunting exclusion criteria: * prior mechanical ventilation or surfactant administration * major congenital anomaly * abnormality of the airway * respiratory distress secondary to an etiology other than respiratory distress syndrome (pneumothorax, meconium aspiration syndrome, pneumonia, hypoxic-ischemic encephalopathy) * apgar score \< 5 at 5 minutes of age

Keywords: laryngeal mask airway surfactant respiratory distress syndrome neonate
a study of nonsteroidal aromatase inhibitors plus abemaciclib (ly2835219) in postmenopausal women with breast cancer

Conditions: Breast Cancer

Summary: the main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (nsai) plus abemaciclib are in postmenopausal women with breast cancer. participants will be randomized to abemaciclib or placebo in a 2:1 ratio.


Eligibility criteria:
inclusion criteria: * have a diagnosis of hormone receptor-positive (hr+), human epidermal growth factor receptor 2-negative (her2-) breast cancer * have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease * have postmenopausal status * have either measurable disease or nonmeasurable bone-only disease * have a performance status ≤1 on the eastern cooperative oncology group (ecog) scale * have adequate organ function * have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy * are able to swallow capsules exclusion criteria: * have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis * have inflammatory breast cancer * have clinical evidence or a history of central nervous system (cns) metastasis * are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer * have received prior (neo)adjuvant endocrine therapy with a disease-free interval ≤12 months from completion of treatment * are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer * have received prior treatment with everolimus * have received prior treatment with any cyclin-dependent kinase (cdk) 4/6 inhibitor (or participated in any cdk4/6 inhibitor clinical trial for which treatment assignment is still blinded) * have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-b ligand (rank-l) targeted agents \<7 days prior to randomization * are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study * have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively * have had major surgery within 14 days prior to randomization

Keywords: monarch 3
effects of acupuncture on sjögren's syndrome

Conditions: Sjogren's Syndrome

Summary: sjögren's syndrome (ss) is a multisystemic chronic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands, resulting in salivary and lacrimal glands hypofunction, with symptoms of dry eyes and mouth. xerostomia and xerophthalmia present profound negative impact on patients' quality of life, especially due to difficulties in swallowing, dysarthria, dysgeusia, halitosis and burning tongue, discomfort and visual disturbances that lead to daily activities difficulty such as driving or reading. although some drugs may improve symptoms and prevent ss complications, they can cause significant adverse effects and even fail to relieve symptoms. integrative and complementary techniques have become a therapeutic option for ss patients. scientific evidence has supported the efficacy of acupuncture in relieving symptoms of xerostomia and xerophthalmia. due to the lack of well-controlled and standardized clinical studies, this study aimed to conduct a randomized and controlled trial to determine the efficacy of acupuncture as a therapeutic option for ss patients' symptoms relief.

the present study is designed as a 24-month, single centre, double-blind, randomized, controlled, two-arm clinical trial (acupuncture and control). the research will be conducted following the consort recommendations and the stricta extension. the study care protocol will consist in acupuncture or control intervention at the selected acupoints (r6, e6,e2, ig4, vc24, ta23, b2) for 8 weeks, 20 minutes sessions with 12 weeks of follow up. complementary clinical approaches (sialometry, sialochemistry, schirmer test, staining with topical lissamine green), and the questionnaires (ohip-14, eular sjögren's syndrome patient reported index (esspri), xerostomia inventory, ocular surface disease index (osdi) will be performed in weeks 1, 8 and 12. the control group will consist of superficial acupuncture, or placebo, or sham. after all interventions and evaluation methods completed, data will be analyzed for their distribution and homogeneity in order to choose the most appropriate statistical test.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years old, both genres, who consent to participate of the study * patients who were diagnosed with sj according to the criteria of the american college of rheumatology and the european league against rheumatism exclusion criteria: * patients who have undergone head and neck radiation therapy; * patients with a history of neoplasias and salivary gland infections; * patients with acquired immunodeficiency virus infection, sarcoidosis, viral hepatitis, diabetes mellitus and smokers; * patients with inability to undergo total saliva collection by established techniques; * patients who can not attend regular acupuncture sessions; * patients who had a change in the dosage of medications in use within 6 weeks before the start of the study. * patients who received acupuncture therapy up to 6 weeks prior to the start of the study.

Keywords: sjogren's syndrome xerostomia xerophthalmia acupuncture
vertebral artery and cerebral hemodynamics after various head positions & manipulation in patients with neck pain

Conditions: Vertebral Artery Dissection; Cerebrovascular Accident; Stroke

Summary: the investigators are performing a study to determine, in patients with chronic/recurrent neck pain, the cerebrovascular hemodynamic consequences of cervical spine movements, including manipulation, in vivo using fmri technology on vertebral and cranial blood flow dynamics affecting brain perfusion, and extend the current data set on these variables

the goal of the study is to further investigate in patients with chronic/recurrent neck pain, the cerebrovascular hemodynamic consequences of cervical spine positions, including manipulation, in vivo under clinically relevant circumstances using two advanced mri technology on the vertebral and posterior cerebral and cerebellar blood flow dynamics affecting brain perfusion. according to the knowledge of the investigators, a study utilizing mri to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these blood vessels has yet to be conducted.

Eligibility criteria:
inclusion criteria: 1. adults aged 18 years and older with chronic/recurrent neck pain grade ii. 2. must have been prescribed cervical spinal manipulation for treatment of their neck pain condition. exclusion criteria: 1. a history of neck pain with associated arm pain within the last 6 months 2. any current or history of neurologic symptoms including facial or extremity weakness, abnormal sensation to the face, body, or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing 3. history of new or severe (visual analogue scale \>6) headaches in the last 3 months 4. any contraindications to mri 5. any history of using drugs that affect blood flow such as warfarin, or anti-coagulants.
international takotsubo registry (intertak registry)

Conditions: Takotsubo Cardiomyopathy

Summary: this is a multicenter, multinational, prospective and retrospective, observational study of patients with takotsubo cardiomyopathy (ttc). data on natural profile (demographical characteristics, clinical phenotype, laboratory values, electrocardiography parameters, echocardiography parameters, coronary angiography parameters, medication) and outcome are systematically collected. our aim is to gain a better insight into the clinical profile and pathophysiology of ttc.

registry is an open-ended study and eligible individuals are assessed at index event and follow-up on their phenotypical characteristics. furthermore, outcome data are collected (by clinical visits or telephone follow-up). in addition, participants are given the option to consent to the donation of biosamples for the purposes to identify ttc specific biomarkers and mutations (sub-study on behalf of the registry).

Eligibility criteria:
inclusion criteria: mayo clinic diagnostic criteria (prasad et al. american heart journal 2008) 1. transient hypokinesis, akinesis, or dyskinesis of the left ventricular mid segments with or without apical involvement; the regional wall motion abnormalities extend beyond a single epicardial vascular distribution; a stressful trigger is often, but not always present.\* 2. absence of obstructive coronary disease or angiographic evidence of acute plaque rupture. † 3. new electrocardiographic abnormalities (either st-segment elevation and/or t-wave inversion) or modest elevation in cardiac troponin. in both of the above circumstances, the diagnosis of ttc should be made with caution, and a clear stressful precipitating trigger must be sought. \* there are rare exceptions to these criteria such as those patients in whom the regional wall motion abnormality is limited to a single coronary territory. † it is possible that a patient with obstructive coronary atherosclerosis may also develop ttc. exclusion criteria: patients with myocarditis

Keywords: broken heart syndrome, stress cardiomyopathy
contrast-enhanced ultrasound for the evaluation of complex renal cysts

Conditions: Complex Renal Cyst

Summary: complex renal cysts are often incidentally detected on imaging. the differential diagnosis of the complex renal cyst includes various benign cystic lesions, which are based on the bosniak classification scheme. currently the standard of care in evaluating a complex renal cyst is using a contrast-enhanced computed tomography (ct) scan, or a contrast-enhanced magnetic resonance imaging (mri) scan. since both of these modalities present adverse events due to frequent high doses of radiation, a technique such as a contrast-enhanced ultrasound (ceus) can be used to obtain the same results, without having to impose high doses of radiation upon a patient.

by evaluating complex renal cysts using a contrast-enhanced ultrasound (ceus), it can be established as to whether or not the results are better, the same, or worse, when compared to ct and/or mri scans.

Eligibility criteria:
inclusion criteria: * at least 18 years old and capable of giving informed consent * all patients undergoing ct evaluation of complex renal cysts at our centre (either initially or in follow-up) * a complex renal cyst defined as bosniak iif, iii or iv exclusion criteria: * pregnant patients * patients with contrast allergies * patients with non-cystic, solid renal masses * patients with simple cysts (bosniak class i and ii)

Keywords: complex renal cysts contrast enhanced ultrasound
pk similarity prospective phase 3 study in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a phase 3 study to compare the pharmacokinetics, efficacy and safety between ct-p10, rituxan and mabthera in patients with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: 1. patient is male or female between 18 and 75 years old, inclusive. 2. patient has a diagnosis of ra according to the revised 1987 acr classification criteria (arnett et al 1988) for at least 6 months prior to randomization. 3. patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum crp ≥1.5 mg/dl (≥15 mg/l) or an esr ≥28 mm/hour. 4. patient has experienced an inadequate response to previous or current treatment with the anti-tnf agents infliximab 5. patient has a proper discontinuation period after treatment with interleukin-1 receptor (il-1r) antagonist, interleukin-6 receptor (il-6r) antibody, or abatacept. exclusion criteria: 1. patient has taken more than 2 biologic agents. 2. patient has previously been administered rituximab or participated in a rituximab biosimilar study. 3. patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins. 4. patient has current or past history of chronic infection with hepatitis b, hepatitis c, or infection with human immunodeficiency virus (hiv)-1 or -2 or who has a positive result to the screening test for these infections. 5. patient has an infection requiring oral antibiotics 2 weeks before randomization, parenteral injection of antibiotics 4 weeks before randomization, other serious infection 6 months before randomization, a history of recurrent herpes zoster or other chronic or recurrent infection 6 weeks before randomization.