Kornimate/medical-research-clean huggingface dataset:
using a personal heart rhythm monitor to diagnose paroxsymal atrial fibrillation in the community

Conditions: Paroxysmal Atrial Fibrillation; Stroke

Summary: this propsective study aims to compare the diagnostic yield of a personal heart rhythm monitor (phrm) with an automated cardiac event recorder (acer) to detect paroxysmal atrial fibrillation paf). the investigators hypothesise that the phrm, used intermittently for 3 months, will detect significantly more cases of paf than the acer, used continuously for one week. a case-control sub-study will identify individuals with confirmed paf, and matched individuals with no evidence of paf, to identify potential serum biomarkers for paf. a further case-control study will assess markers of left atrial function in patients with paf and their matched controls. another case-control sub-study will determine the significance of frequent atrial premature beats (apbs) in the development of af over a one year period.

patients with suspected af will be initially referred to a community-based, nurse-led arrhythmia clinic by their general practitioners over a 15-month period. all patients will be issued with a one week acer (the 'r. test 4 evolution'), seen as the 'best-practice' investigation for this population group. participants will also be issued with a phrm for three months. they will be instructed to take regular twice-daily, 30 second recordings with additional recordings in the event of relevant symptoms. they will return the acer after one week and the phrm after 3 months. a subgroup of participants (target recruitment number = 100) will undergo transthoracic echocardiography. a 40ml venous blood sample will also be taken. another small subgroup (target recruitment = 20) will be asked to continue twice-daily recordings using the phrm for a further nine months and will be issued with a repeat one week acer at study completion.

Eligibility criteria:
inclusion criteria: * suspected paroxysmal af (either palpitations consistent with af or an irregular pulse) * 12-lead resting ecg confirming sinus rhythm * capacity to consent to study * english-speaking * life expectancy at least one year exclusion criteria: * previous diagnosis of af * recent history of syncope * recent history of cardiac-sounding chest pain * a resting ecg suggestive of alternative arrhythmia * inability to use the telephone * thyrotoxicosis

Keywords: cardiac monitoring biomarkers transthoracic echocardiography
lux-lung 7: a phase iib trial of afatinib(bibw2992) versus gefitinib for the treatment of 1st line egfr mutation positive adenocarcinoma of the lung

Conditions: Lung Neoplasms

Summary: this is a randomised, open-label, phase iib trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed diagnosis of stage iiib / iv adenocarcinoma of the lung. 2. documented activating epidermal growth factor receptor mutation (del19 and/or l858r) with tumour tissues. 3. at least one measurable lesion according to response evaluation criteria in solid tumours version 1.1 4. eastern cooperative oncology group (ecog) performance status 0 or 1. 5. age \>= 18 years. 6. adequate organ function as defined by the following criteria: serum aspartate transaminase(ast) and serum alanine transaminase(alt) =\ =1.5 x 109/l creatinine clearance \> 45ml / min platelets \>= 75 x 109/l exclusion criteria: 1. prior systemic chemotherapy for stage iiib or iv non-small cell lung cancer. neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression. 2. prior treatment with epidermal growth factor receptor targeting small molecules or antibodies. 3. major surgery within 4 weeks of study randomisation. 4. active brain metastases 5. meningeal carcinomatosis. 6. previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator. 7. known pre-existing interstitial lung disease. 8. clinically relevant cardiovascular abnormalities as judged by the investigator. 9. cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal. 10. women of child-bearing potential (wocbp) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended. 11. pregnancy or breast-feeding. 12. active hepatitis and/or known hiv carrier 13. any prohibited concomitant medications for therapy with afatinib or gefitinib
predictability of the ability to perform an emergency stop

Conditions: Osteoarthritis; Total Knee Arthroplasty

Summary: several studies exist on patient performance in drive simulators especially around and after surgery. recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. however, in all the datasets driving performance remains highly individual. since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. this study aims at evaluating different possibilities how such performance might be predicted. patients with knee osteoarthritis and patients who have received total knee arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.


Eligibility criteria:
inclusion criteria: * 18-85 y * valid driving license * male and female * right or left knee osteoarthritis, total knee arthroplasty right or left knee * capability to walk with or without a walking stick exclusion criteria: * myocardial infarction/apoplexia \< 6 months * total knee arthroplasty \<5 weeks * new york heart association 3/4 * lacking drivers' license * peripheric sensomotor deficit \<3/5 british medical research council * new fracture of the lower extremity or spine * systemic or metastasised cancer * drug intake with centrally acting substances known to affect reaction time (opioids, e.g. tramadol, oxycodone, morphine, tilidin)

Keywords: driver reaction time
a clinical study of nemtabrutinib in japanese participants with hematological malignancies (mk-1026-002)

Conditions: Mature B-cell Neoplasms

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary efficacy of nemtabrutinib in japanese participants with mature b-cell neoplasms.


Eligibility criteria:
the main inclusion and exclusion criteria include but are not limited to the following: inclusion criteria: * histologically confirmed b-cell malignancy: * chronic lymphocytic leukemia (cll) * small lymphocytic lymphoma (sll) * waldenström's macroglobulinemia (wm), * lymphoplasmacytic lymphoma (lpl) * other b-cell neoplasm * failed or intolerant to either at least 2 prior regimens given in combination or sequentially or have received 1 prior bruton's tyrosine kinase (btk)-containing regimen when a btk inhibitor is approved as first line therapy * have the ability to swallow and retain oral medication * is japanese exclusion criteria: * active hepatitis b virus (hbv)/hepatitis c virus (hcv) infection at study entry * history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years * known history of human immunodeficiency virus (hiv) infection * clinically significant gastrointestinal abnormalities that might alter absorption (eg, gastric bypass surgery, gastrectomy) * underlying history of severe bleeding disorders * history or concurrent condition of pneumonitis/interstitial lung disease
using personal mobile technology to identify obstructive sleep apnea in children with down syndrome (upload)

Conditions: Down Syndrome; Obstructive Sleep Apnea; Child

Summary: this study aims to see if mobile video clips (smartphone recordings) can be used to screen children with down syndrome to identify those at highest risk of obstructive sleep apnea (osa), so they can be prioritized for an earlier sleep study. parents will be asked to record short video clips of their child sleeping, and then rate whether they think their child has osa. later, children will undergo a sleep study to compare to the ratings.

children with down syndrome have approximately a 50% chance of developing obstructive sleep apnea (osa) in their lifetime. osa is a serious condition where a person stops breathing periodically during sleep; it is associated with high blood pressure, behavioural issues, and lower quality of life. early diagnosis and treatment is critical, but the best way to diagnose osa, a 'sleep study', is in short supply. given the limited resources, this study aims to see if mobile video clips (smartphone recordings) can be used to screen children with down syndrome to identify those at highest risk of osa, so they can be prioritized for an earlier sleep study. parents of children with down syndrome, recruited from clinic, will be asked to record short video clips of their child sleeping. parents will independently rate whether they think their child has osa and how severe it is, based on the videos, as will two clinicians. parents will also watch an educational webinar and be asked to re-rate the presence and severity of osa in their child, to see if the webinar improves their accuracy. finally, children will undergo a sleep study to compare to the ratings. this study will help determine whether videos can be used to accurately screen for osa in this high risk population, prioritizing children for earlier diagnosis and treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of down syndrome * within the catchment area of the children's hospital of eastern ontario down syndrome clinic exclusion criteria: * previous diagnosis of sleep-disordered breathing on polysomnography * no access to mobile technology to record video clips * children unable to cooperate for polysomnography * caregiver does not speak french or english

Keywords: polysomnography pediatric down syndrome obstructive sleep apnea screening tool mobile technology
immunotherapy for recurrent cervical cancer refractory to platinum-based chemotherapy

Conditions: Recurrent Cervical Carcinoma; Persistent Advanced Cervical Carcinoma; Chemotherapy; Anti-PD-1 Antibody; Immunotherapy

Summary: for recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. however, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. the marketing of anti-pd-1 antibody has provided an opportunity of curative management. this single arm, open, phase ii trial would recruit 34 eligible patients. a combination of anti-pd-1 antibody camrelizumab and albumin-bound paclitaxel would be given for first 9 patients. if at least total 2 patients achieved complete or partial remission, or at least total 6 patients achieved complete or partial remission or stable disease, the same regimen would be given for rest patients. the primary end is overall response rate (orr). the second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. a molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.


Eligibility criteria:
inclusion criteria: * female of 18-75 years old * eastern cooperative oncology group score 0-1 * pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage ia1 (with lymph-vascular space invasion) to ivb, which had accepted radical treatment for the purpose of cure * having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen * at least one measurable lesion defined by response evaluation criteria in solid tumors (recist) guideline 1.1 * anticipative survival period of 3 months or more * lab testing within reference ranges * with appropriate contraception * provided consents of participating the trial exclusion criteria: * with brain metastasis * with addiction to psychiatric medications or with mental disorders * with following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of \> 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to pd-1 antibody, or pd-l1 antibody, or pd-l2 antibody, or cytotoxic t lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency * with adverse effects more than common terminology criteria for adverse events grade 1 (except for alopecia), which caused by previous anti-tumor treatment * with infective disease which need systematic treatment within 14 days * with severe open trauma, fracture or major surgery with past 4 weeks * with potential allergy or intolerance to study regimens * not eligible for the study judged by researchers
misoprostol for treatment of fetal death at 14-28 weeks of pregnancy

Conditions: Intrauterine Fetal Demise

Summary: the purpose of the proposed study is to test - in a randomized, blinded trial - two different doses of the prostaglandin e1 analogue misoprostol administered buccally as a treatment for fetal death at 14 - 28 weeks, inclusive, of pregnancy. at such an advanced stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely evacuation is vital in order to avoid the possibility of, among other things, potentially life-threatening maternal coagulopathies. current approaches to uterine evacuation in these cases include dilatation and evacuation (d\&e) surgery (in less advanced pregnancies) and labor induction with a variety of products. misoprostol has been demonstrated to be as effective as, or more effective than, either oxytocin or prostaglandin e2 analogues for this indication in a number of small, non-fda-approved trials which have been published in the peer-reviewed literature. in the absence of more formal study of this treatment, however, dosages are not standardized, pathways of administration vary, and other uncertainties linger. the purpose of the protocol proposed herein is to formally establish, via a randomized, double-blinded study, the safety and effectiveness of misoprostol for this indication, and to compare the value of two distinct doses, so that providers may henceforward proceed with greater authority and confidence.


Eligibility criteria:
inclusion criteria: * women presents with spontaneous fetal death * gestational age of fetus between 14-28 weeks exclusion criteria: * transmural uterine scar; * allergies or other contraindications to use of misoprostol; * placental abruption with active hemorrhage; * complete placenta previa; * extreme uterine structural anomalies; * or other contraindications to vaginal delivery of the fetus; * presentation in active labor (moderate to severe contractions every 10 minutes); or * four or more previous deliveries

Keywords: intrauterine fetal death misoprostol
the effect of a multistrain probiotic on metformin tolerance and efficacy with microbiota and stool metabolome in insulin-resistant women - a 12-week randomized, placebo-controlled, double-blind study

Conditions: Insulin Resistance

Summary: the goal of this study is to evaluate the efficacy of metformin on insulin sensitivity and vascular endothelial function with respect to gut microbiota and metabolome in women with established insulin resistance and its tolerance after 12 weeks of probiotic therapy. the hypothesis is probiotic therapy in women with established insulin resistance undergoing metformin treatment increases the drug's efficacy to improve insulin sensitivity and intestinal endothelial function, and reduces gastrointestinal side effects. study participants will be randomly assigned to 2 groups, taking a probiotic (gs) or a placebo (gp). the randomization scheme will be computer-generated using permuted blocks of block size 4.


Eligibility criteria:
inclusion criteria: * women 25-45 years old, menstruating, bmi 25-32.9 kg / m2, insulin resistance based on the homa-ir index (cut-off point 2.5 exclusion criteria: * type 1 and 2 diabetes, * poorly controlled arterial hypertension (mean sbp values\> 140mmhg and / or mean dbp values\> 90mmhg) within the last month and / or the need to modify pharmacological treatment, * 2nd degree obesity, bmi\> 35 kg / m2, * lipid disorders requiring pharmacological treatment in the last 3 months before the start of observation or during observation, * positive history of ischemic heart disease, carotid and / or lower limb atherosclerosis, * features of heart failure on physical examination and / or additional examinations (chest x-ray, echocardiography), * clinically significant arrhythmias or conduction disturbances, * chronic kidney disease with creatinine clearance \<60ml / min / 1.73m2, * clinically significant impairment of liver function (transaminase values 3 times the normal range), * acute or chronic, clinically evident inflammatory process (diseases of connective tissue and joints, inflammatory processes of the respiratory tract, inflammatory processes of the genitourinary system, inflammation of the head and neck), * acute infection in the last month, * cancer, * alcohol abuse, drug addiction, * taking medications that may interfere with test results, * taking antibiotics, steroids, antifungal and antiparasitic agents 4 weeks before the examination (not applicable to topical antifungal agents). * taking pre - and / or probiotics in the last 12 weeks before the test * travel to tropical countries in the last 4 weeks prior to the survey * other conditions that may pose any risk to the patient during the follow-up.

Keywords: insulin resistance multistrain probiotic gut microbiota
impact of the covid-19 on respiratory syncytial virus (rsv) epidemic

Conditions: RSV Infection

Summary: the magnitude of seasonal respiratory syncytial virus (rsv) epidemics brings each year new logistical challenges for the hospitalization of young infants with bronchiolitis that overwhelm hospital capacities and lead to specific winter plans with deprogramming and mobilization of human and logistical resources. the covid-19 pandemic has changed the way winter epidemics are presented. for example, the seasonal rsv epidemic was shifted by several months in lyon, with an impression of a lower incidence of hospitalized cases, with a population of older children and with fewer signs of clinical severity. this is largely attributable to the widespread use of barrier gestures and social distancing measures, known as "non-pharmacological interventions" (npi). given the magnitude of the reduction of the rsv epidemic, it is legitimate to analyze the benefits of npis to draw lessons for maintaining preventive measures around rsv-vulnerable populations; moreover, new preventive pharmacological interventions are soon to be marketed, whether they are particularly refined and long half-life anti-rsv monoclonal antibodies, rsv vaccines for mothers or for newborns and infants. in this perspective, it is crucial to properly define the populations at risk of severe disease to establish a legitimate hierarchy in the implementation of different preventive strategies. the study of the rsv epidemic is a high potential model because of the convergence of epidemiological, virological, and pharmacological knowledge. however, the study of the impact of the pandemic on the epidemiology of rhinovirus also seems promising because, for reasons unknown to date, it seems that the pandemic did not have the same reducing impact on the rhinovirus epidemic; in the latter case, the interest is to confirm the resistance of this virus and to look for more fundamental explanations, for example, on viral interactions.


Eligibility criteria:
inclusion criteria: * • child hospitalized at " hôpital femme mère enfant ", lyon, france * polymerase chain reaction (pcr) positive at respiratory syncytial virus (rsv) exclusion criteria: * • parent's refusal to participate

Keywords: bronchiolitis asthma pneumonia
effects of different crystalloid solutions for extra-corporeal membrane oxygenator (ecmo) priming

Conditions: Acute Respiratory Failure

Summary: crystalloid solutions modify acid-base equilibrium according to their electrolyte composition. moreover, it has been suggested that these alterations are generated by the difference between the solution strong ion difference (sid) and the plasma bicarbonate level. an increased risk of acute kidney injury and renal replacement therapy has been associated to the infusion of chloride rich crystalloids. this study aims to compare, in patients with acute respiratory failure undergoing ecmo support, the effects on acid-base status and renal function of crystalloids commonly employed for circuit priming to a balanced solution created with a sid equal to patients' bicarbonate level.


Eligibility criteria:
inclusion criteria: * patients with acute respiratory failure in need for ecmo treatment exclusion criteria: * none

Keywords: acute respiratory failure ards ecmo lung transplantation acid-base equilibrium