Kornimate/medical-research-clean huggingface dataset:
rezolve2 clinical investigation

Conditions: Coronary Artery Disease; Coronary Artery Stenosis

Summary: the restore ii clinical trial is intended to assess safety and performance of the rezolve2 bioresorbable coronary scaffold in native coronary arteries.


Eligibility criteria:
primary inclusion criteria: * patient has evidence of myocardial ischemia or a positive functional study * patient has a normal ck-mb * target lesion has a visually estimated stenosis of ≥50% and \<100% * target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.75mm and ≤ 3.3mm * target lesion length must be ≤ 14mm primary exclusion criteria: * patient has experienced a myocardial infarction (ck-mb or troponin \> 5 x uln) within 72 hours of the procedure * patient has a left ventricular ejection fraction \< 30% * patient has unprotected lest main coronary disease with ≥50% stenosis * the target vessel is totally occluded (timi flow 0 or 1) * target lesion involves a bifurcation (a lesion with a side branch ≥ 2.0 mm in diameter containing a ≥ 50% stenosis). * target lesion is located within a bypass graft * target lesion has possible or definite thrombus
drug resistance among asymptomatic infection

Conditions: Drug Resistant Malaria; Asymptomatic Infections; Migrant Workers

Summary: a cross-sectional study will be conducted in selected 2 sentinel sites for assessment of drug resistance falciparum and vivax among asymptomatic infection in migrant workers in myanmar.

although malaria prevalence is decreasing in myanmar, drug resistance threatens the malaria elimination by 2030 especially high risk persons including migrant population. previous study indicated that asymptomatic malaria parasite carried drug resistance gene such as k13 mutant that is genetically responsible for artemisinin resistant falciparum malaria. these asymptomatic carries may be a source to spread the disease and it is very important to conduct the surveillance on drug resistance status among high vulnerable persons. unfortunately, there is no study to assess the drug resistance molecular markers in asymptomatic malaria among migrant workers in myanmar. therefore, this study fulfills the gaps of knowledge on important of asymptomatic hidden infection exploring to formulate the recommendation for elimination of malaria in myanmar. in this study, asymptomatic infections are screened by rapid diagnostic test, microscopy and molecular methods.

Eligibility criteria:
inclusion criteria: * age above 6 year * migrant population (moving from their normal residence place and working at a new place such as forest related activities, gold-mines or plantation sites for more than 3 months- 3 years) * both sex * participant who give informed-consent to participate the study exclusion criteria: * known clinical malaria cases regardless of the species detected * patients with clinical symptoms of malaria at the time of examination * known history of malaria within 14 days

Keywords: malaria falciparum vivax myanmar migrant workers asymptomatic infection drug resistance
plasma betatrophin levels in non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the study searched for answers to two questions: 1-what are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls. 2. is there any relationship between plasma betatropin levels and different stage of non-alcoholic fatty liver disease 2.is there any relationship between plasma betatropin levels and metabolic parameters in subjects with non-alcoholic fatty liver disease.


Eligibility criteria:
inclusion criteria: * patients with biopsy proven non-alcoholic fatty liver disease exclusion criteria: * taking any drugs * \>20 gr/day alcohol consumption * chronic metabolic diseases * morbid obesity

Keywords: non-alcoholic fatty liver disease betatrophin
the study of single dose administration of gr2002 injection in chinese health volunteers

Conditions: Asthma

Summary: to evaluate the pharmacokinetic (pk) characteristics and pharmacological effect of gr2002 injection in chinese healthy volunteers

this is a randomized, double-blind, placebo-controlled phase i clinical trial to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity characteristics of single subcutaneous administration of gr2002 injection in healthy adult chinese subjects. the initial dose group is 35mg, and the subsequent doses will gradually increase. only after all subjects in the current dose group have completed at least 2 weeks of safety and tolerance observation and confirmed safe tolerance, can they enter the next dose group for medication observation until the "dose increase termination standard" is reached. follow up will be conducted for at least 12 weeks ± 3 days after completion of medication administration.

Eligibility criteria:
inclusion criteria: * 1. age of 18 to 55 years, inclusive, male or female 2. bmi between 19 kg/m2 and 26 kg/m2 (inclusive) 3. healthy volunteers exclusion criteria: * 1. history of chronic disease or serious disease 2. subject with severe psychological or mental illness 3. not enough washing-out period for previous therapy 4. other.
effectiveness of the treatment with continuous positive airway pressure(cpap)in stable heart failure with ejection fraction more than 45% and sleep disordered breathing

Conditions: Heart Failure; Sleep Respiratory Disorders

Summary: the respiratory sleep disorders are a major cardiovascular risk factor. in fact there is enough scientific evidence that supports the association between apnea-hypopnea syndrome (sash) and cardiovascular disease (hypertension, stroke, heart failure ....the objective of this study is to estimate the effectiveness of the continuous positive pressure airway (cpap) in patient with chronic heart failure with normal ejection fraction but dyastolic dysfunction and sleep disordered breathing during the sleep.


Eligibility criteria:
inclusion criteria: 1. ejection fraction\> 45%, which also ruled out significant left ventricular dilation 2. at least two abnormal indices of diastolic function. exclusion criteria: 1. not sinus rhytm 2. severe lung disease (fev1 or fvc less than 50%) 3. significant valvular or congenital heart disease, primary 4. unstable angina, myocardial infarction or cardiac surgery within three months prior to inclusion 5. hypertrophic cardiomyopathy 6. presence of significant psychiatric disorders. 7. severe hypersomnia . (epworth\> 20) 8. severe pulmonary hypertension measured by doppler, 9. facial deformity and / or defect of nasal patency.
the effect of aroma on anxiety among children with autism.

Conditions: Anxiety; Autism Spectrum Disorder

Summary: this study evaluates the effects of essential oils on anxiety scores among children who have an autism spectrum disorder. one third of the children will receive a control blend of oils, one third of the children will receive a test blend of oils, and the other third will receive a second test blend of oils.

essential oils have been found in studies to reduce both stress and anxiety as measured by an anxiety inventory, but studies have not tested these effects among children who have an autism spectrum disorder. the essential oils used in this study are administered each morning for a total period of four weeks, with an optional second exposure on an as-needed basis during the final two of the four weeks of the study. the oils are administered during this time to evaluate both the preventive effects and the treatment effects of the essential oils. anxiety is measured on an anxiety inventory, which is completed by the parent of the participant at the end of each week during the study. parents complete this data online, allowing them to participate from anywhere in the u.s.

Eligibility criteria:
inclusion criteria: * age: 6-11 years old at enrollment * diagnosed with an autism spectrum disorder exclusion criteria: * mast cell activation syndrome * history of adverse response to essential oil inhalation

Keywords: essential oils aromatherapy anxiety autism spectrum disorder
prodromal impact intervention for children at elevated likelihood of asd

Conditions: Autism Spectrum Disorder

Summary: this randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of infants with elevated likelihood of autism spectrum disorder (asd). the children´s social-communicative abilities and the related brain activity will be evaluated at three time points: before the start of the intervention (pre-intervention), immediately after its conclusion (post-intervention) and 6 months after its conclusion (follow-up).

previous research has shown that parent-implemented interventions are effective in improving the social skills of children with autism spectrum disorder (asd).considering that several differences in social and non-social skills start to emerge before a diagnosis can be made, this project aims to investigate the effects of an adapted prodromal version of an evidence-based parent-mediated intervention (project impact) in children with an elevated likelihood to develop asd (namely siblings and children who were born preterm). the effect of the intervention will be evaluated at both behavioural and neural levels. the intervention is suitable for infants and consists of 12 session with the child and his/her parents, of maximum 2 hours each, one session per week, delivered by therapists of the home guidance and home guidance centers in flanders. children between 9 and 18 months old and their parents will participate in the study. they will be randomly assigned to the impact intervention group or a no-intervention group (monitoring only). the families will be invited to come to the faculty of psychology and pedagogical sciences at three time points: before the start of the intervention, immediately after the end of the intervention (which is expected to last 12 weeks) and 24 weeks after the end of the intervention.

Eligibility criteria:
inclusion criteria: * elevated likelihood of asd: the child must be a preterm (less than 30 weeks of gestation) or a sibling/half-sibling of a child with diagnosed asd. * parents are dutch, english on french speakers. exclusion criteria: * the child must not have a diagnosis of other neurological or developmental disorders.

Keywords: autism autism spectrum disorder siblings preterm elevated likelihood of asd
polatuzumab, rituximab and orelabrutinib combination regimen (pro) in the treatment of elderly frail patients with treatment-naive non-gcb dlbcl

Conditions: Diffuse Large B Cell Lymphoma

Summary: this prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with non-gcb dlbcl. this study is to evaluate the preliminary efficacy and safety of the combination of polatuzumab, rituximab, and orelabrutinib in this population. the primary endpoint is cr rate after induction therapy.


Eligibility criteria:
inclusion criteria: * patients with histopathologically confirmed dlbcl; * the sga evaluation result of octogenarians or 60-79 years old is unfit or f ra il; * non-germinal center (non-gcb) type; * ecog performance status score of 0-3 points; ⑤ no previous treatment for lymphoma (unless glucocorticoid); 6 radiographic investigation to measurable disease, defined as the longest diameter with at least one lymph node disorder \> 1.5 cm, or at least one extranodal lesion \> 1.0 cm in the longest diameter; ⑦ adequate organ function; * life expectancy ≥ 12 weeks; ⑨ signed written informed consent. exclusion criteria: * accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy diseases, autoimmune diseases and severe immunization diseases, etc.; * laboratory abnormalities at screening (unless caused by lymphoma) a) anc \< 1.5 x 109/l, plt \< 80 x 109/l b） coagulation: inr greater than 1.5 x upper limit of normal; pt and aptt greater than 1.5 x upper limit of normal c） liver function: alt or ast 2 times higher than upper limit of normal, akp and bilirubin 1.5 times higher than upper limit of normal d） renal function: creatinine high 1.5 times the upper limit of normal, creatinine clearance \< 60 ml/min (estimated by c oc kcroft-gault formula); ③ hiv infection; * hbsag positive patients should be hbv dna negative before enrollment; in addition, if the patients are hbsag negative but hbcab positive (regardless of hbsab status), hbv dna detection is still required; if the results are positive, antiviral therapy is required, and hbv dna negative before enrollment; * requires continuous treatment with strong and moderate cyp3a inhibitors or cyp3a induction agents. patients who have taken strong and moderate cyp3a inhibitors or cyp3a induction agents (or have taken these agents within 5 half-lives) within 7 days prior to the first dose of study drug should not be enrolled; ⑥ inability to swallow capsules or suffering from diseases that seriously affect gastrointestinal function, such as syndrome malabsorption, gastric or small intestinal resection, symptomatic inflammatory bowel disease or partial or complete intestinal obstruction; ⑦ other concurrent and uncontrolled medical conditions that, in the opinion of the investigators, would affect the patients' participation in the study, including patients with psychosis or other patients known or suspected to be unable to fully comply with the study protocol.

Keywords: elderly frail pro non-gcb dlbcl
"improved mother infant feeding interaction (mi-fi) at 12 months with very early parent training"

Conditions: Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating Prevention

Summary: rise in childhood obesity and poor eating habits and eating problems is apparent over the last decades. parents are at lose what the correct way to tackle these problems may be. this study examined whether professional behavioral and nutritional training of first time mothers improves feeding relationship and infants eating habits at 12 months.

from 166 first time mother-infant recruited, 128 completed the trail. intervention group, mother-infant dyads got a month long weekly based training in small workshop groups about nutrition, feeding and parenting when infants were 4-6 months old. training was given by a highly experience pediatric dietitian and social worker. thereafter, internet-based support continued until infants reached 12 months. the control group received customary support via municipal mother-child health clinics. mealtime interactions were videotaped at home setting at 12 months and were evaluated using the chatoor feeding scale by blinded (to group) viewers.

Eligibility criteria:
inclusion criteria: * normal and healthy pregnancy * full term delivery of infants * infants with a normal birth weight and no health problems * mothers recruited had at least a high school education * mothers lived near to or in the city (important for video taping) exclusion criteria: * mothers with mental illness in the present or the past (such as schizophrenia, depression or an eating disorder) * infants with chronic diseases that required specific diets (such as milk allergy) or gastrointestinal diseases (celiac disease, type 1 diabetes, crohn's disease etc.)

Keywords: feeding interaction, infant eating habits, hunger satiety cues, childhood obesity
cluster headache treatment survey

Conditions: Cluster Headache

Summary: the objective of this study is to survey patients with cluster headache about treatment effectiveness and their views on treatments. participants will complete one brief questionnaire online.


Eligibility criteria:
inclusion criteria: * patients with episodic or chronic cluster headache that has been diagnosed by a health care professional (no documentation is needed, participant must simply state that he or she has been diagnosed) exclusion criteria: * unable to speak english (the survey is only in english) * unable to use a computer to take the online survey * unable to provide consent
immunoadsorption in patients with pulmonary hypertension

Conditions: Pulmonary Hypertension; Pulmonary Resistance

Summary: the purpose of this study is to investigate, if immunoadsorption of autoantibodies with subsequent substitution of immunoglobulins is able to improve haemodynamics in patients with pulmonary hypertension.

increased pulmonary precapillary vascular resistance due to vasoconstriction and vasoproliferative processes is the basic pathophysiological mechanism in the development of pulmonary hypertension (ph). in patients with pulmonary arterial hypertension (ph) production of endothelin-1 (et-1) is increased and elevated et-1 plasma levels correlate with ph severity as recently shown autoantibodies against the endothelin-1 typ a and angiotensin ii typ-1 receptor, which have a high incidence in ph-patients, may also play an important role in the pathophysiology of ph (dandel et al.). the concept of this study is that the elimination of these autoantibodies by immunoadsorption with protein a may improve haemodynamics and patient wellbeing. immunoglobulins are substituted after immunoadsorption to minimize infection risk.

Eligibility criteria:
inclusion criteria: * pulmonary hypertension (ph) * nyha ii-iv * medical treatment of ph respective to current guidelines * 18 years or older * written informed consent of the patient exclusion criteria: * pulmonary hypertension due to left ventricular dysfunction * decompensated heart failure * need for catecholamines * active infection * pregnancy * malign tumor disease * other secondary disease with life expectancy \< 1 year * refusal by the patient

Keywords: pulmonary hypertension autoantibodies immunoadsorption immunoglobulin substitution right ventricular function
vitamin c, thiamine and hydrocortisone for the treatment of septic shock

Conditions: Septic Shock

Summary: the purpose of this study is to determine whether the combination therapy (vitamin c,thiamine and hydrocortisone) is effective in the treatment of septic shock.

septic shock is a leading cause of morbidity and mortality in critically ill patients worldwide. a potential benefit of vitamin c with thiamine and low-dose hydrocortisone in the treatment of septic shock has recently been described(pmid 27940189) . the patients with septic shock who received this combination of medications weaned off pressors earlier, suffered less organ failure, and had improved mortality. the doses of vitamin c used in this trial are high, yet seemed to be safe and can be considered for use. in this randomized controlled trial, we aim to evaluate the effect of the combination therapy (vitamin c,thiamine and hydrocortisone) on septic shock.

Eligibility criteria:
inclusion criteria: * age 18 years old or older * onset of septic shock within 12 hours exclusion criteria: * systemic corticosteroid therapy within the last 3 months before septic shock * high-dose steroid therapy * immunosuppression * pregnant * known glucose-6 phosphate dehydrogenase (g-6pd) deficiency * known hemachromatosis * known allergy to vitamin c, hydrocortisone, or thiamine * anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician) * refusal of the attending staff or patient family

Keywords: septic shock vitamin c thiamine hydrocortisone mortality
immunohistochemical staining of p16 for the screening of cervical cancer

Conditions: Cervical Cancer Screening; p16 Protein; Cytology; High-risk Human Papillomavirus; Diagnostic Accuracy; Histology; Cervical Intraepithelial Neoplasia

Summary: cyclin kinase inhibitor p16ink4a has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. this study is to investigate the clinical value of p16ink4a and high-risk human papillomavirus (hrhpv) detection of cervical intraepithelial neoplasia (cin) 2 or more severe lesions (cin2+). all eligible participants accept p16ink4a testing, with cytology and/or hrhpv assay. p16ink4a immunohistochemical staining is performed on the retained specimens of cytology. the primary endpoint is the diagnostic accuracy of p16ink4a compared with cytology and/or hrhpv status based on histology results. the accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * signed an approved informed consents * with sufficient cytology sample for p16 testing * with definite results of cytology and/or high-risk human papillomavirus and cervical histology exclusion criteria: * not meeting all of the inclusion criteria
neglect treatment by prism adaptation in the acute phase

Conditions: Unilateral Spatial Neglect

Summary: this project aims at unveiling the beneficial effects of prism adaptation as early rehabilitation technique to treat unilateral spatial neglect in the acute phase after a brain damage. this syndrome, frequent and very invalidating for daily life activities after a brain damage, is a cognitive disorder of lack of attention towards a part of the space. patients at a first event brain injury hospitalized into the neurology and neurosurgery departments and affected by spatial neglect will undergo to a protocol of five consecutive rehabilitation treatments, being assigned to the experimental (prisms) or control groups (neutral prisms). the effectiveness of the treatment will be assessed with cognitive, functional and motor-related measures, as well as a follow up 3 months later. these results can have a strong impact on the long-term functional outcome of these patients.


Eligibility criteria:
inclusion criteria: * first neurological event, affecting the right hemisphere or the left hemisphere (stroke, brain tumour post-surgery); * structural images of the brain lesion available (magnetic resonance or tomographic scans); * good normal (or corrected) visual acuity; * presence of usn, as assessed by a standard neuropsychological evaluation. exclusion criteria: * previous neurological disorder and/or current or previous psychiatric disease. * presence or suspicion of previous general cognitive deficits documented from the clinical dossier and/or suspicious of possible cognitive deficits ; * presence of difficulty in task's comprehension preventing its completion; * impossibility to sustain a research session of at least 30 minutes (e.g., attentional lability).