Kornimate/medical-research-clean huggingface dataset:
study on the efficacy and safety of a novel tripterygium wilfordii preparation in reducing proteinuria in patients with diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: the investigators designed a randomized parallel controlled clinical study, selected 98 cases of diabetic nephropathy patients with urinary protein \> 1g, randomly assigned into the kunxian capsule + irbesartan group or irbesartan group, 48 weeks of treatment and follow-up, reduced levels of urinary protein and effective relief time, remission rate as the main end point, estimated glomerular filtration rate (egfr) drop rate slope for secondary end points, safety events were also collected. to evaluate the efficacy and safety of kunxian capsule combined with irbesartan in treatment of diabetic nephropathy compared with irbesartan alone.


Eligibility criteria:
inclusion criteria: * conformed to the diagnostic criteria of diabetic nephropathy * no gender limitation, age 18-85 years old, no fertility requirement temporarily * egfr: \>30ml/min/1.73m2（ckd-epi） * urine protein \>1 g/day * no glucocorticoids or/and immunosuppressive therapy was received within 3 months * patients volunteered to participate in this study and signed the informed consent exclusion criteria: * combined with diabetic acute complications or acute kidney injury (aki) * combined with other autoimmune diseases * primary and other secondary renal diseases * patients with hypotension (bp \< 90/60mmhg) or bilateral renal artery stenosis who are not suitable for angiotensin receptor blockers (arb) drugs * there are contraindications to the use of kunxian capsules or allergic to any of the ingredients in kunxian capsules * there are fertility requirements or pregnant, lactation patients * combined with malignant tumor, hepatitis, tuberculosis, hiv, serious infection, rheumatic disease, heart failure, chronic obstructive pulmonary disease (copd) and other serious systemic diseases * kidney transplant or dialysis has been performed * clinicians deem it inappropriate, or patients are unwilling to sign informed consent, have poor compliance, have a history of mental illness, or cannot complete follow-up visits
can shorter time intervals help the baby survive the triad effect of maternal hypertension, caesarean section and spinal anesthesia?

Conditions: Neonatal Hypoxia and Asphyxia

Summary: patients were classified into two equal groups using the presence or absence of hypertension during pregnancy into: hypertensive group (bp\>140/90) and normotensive group (bp≤140/90. the surgical time intervals are assessed and classified the patients accordingly into short and log time interval subgroups (induction of regional anesthesia to delivery (i-d), initial skin incision to delivery (s-d), and uterine incision to delivery (u-d)

surgical times components; induction of regional anesthesia till delivery (i-d interval); incision of the skin till delivery (s-d interval); and incision of the uterus till delivery (u-d interval)) were recorded using a stopwatch. immediately after delivery, umbilical cords were clamped on both ends and an arterial blood sample was collected anaerobically in a pre-heparinized insulin syringe. ph, base excess (be), carbon dioxide pressure (pco2), oxygen pressure (po2) and bicarbonate (hco3) levels were measured at 37oc by ph and gas analyzer (gem, premier3000, usa). the gas analysis was done in less than 30 minutes after sampling. apgar score was assessed by a neonatologist at the 1st and 5th minutes after birth . advanced resuscitation included positive pressure ventilation, chest compression and/or drugs administration. all resuscitated babies were transferred to neonatal intensive care unit for post resuscitation care. fetal distress was defined by an umbilical cord ph \<7.12

Eligibility criteria:
inclusion criteria: * full term pregnancy * singleton pregnancy * no medical disorders except hypertension in group 2 exclusion criteria: * multiple pregnancies * complicated pre-eclamptic cases as placental abruption, eclampsia or hellp syndrome, * preterm pregnancies, * true knots of the cord * reduced liquor, * in labour patients, * fetal distress * infants with major congenital malformations
the fluid translation of research into practice study

Conditions: Critical Care, Fluid Resuscitation

Summary: translating reliable evidence on fluid resuscitation of intensive care patients into clinical practice - improving patient outcomes and containing public health costs

the fluid-translation of research into practice study (trips) is an international, single day, cross-sectional study planned for the second quarter of 2014, coordinated by the george institute for global health, with the purpose of documenting prescribing practices for fluid resuscitation in intensive care units (icus) worldwide. this international cross-sectional study follows on from the publication of large-scale randomized controlled trials and meta-analyses of fluid resuscitation, which provide evidence of how fluid resuscitation may affect patient-centered outcomes. fluid-trips is a repeat of the saline versus albumin for fluid evaluation (safe)-trips which was an international cross-sectional survey conducted in 2007 that had 391 icu's participate from 25 countries and provided insight into international fluid resuscitation practice at that time. along with establishing if fluid resuscitation practices have changed since safe-trips, fluid-trips also aims to determine the relationship between fluid choice and evidence, along with understand other factors that may influence the choice of bolus fluid in clinical practice.

Eligibility criteria:
inclusion criteria: adult patients present in the icu on the study day or admitted during the 24-hour study period will be included in the study sample. exclusion criteria: children under 16 years are excluded

Keywords: adult icu patient fluid resuscitation observational study
frequency of xerostomia and their management in upper aerodigestive tract cancer patients after the end of radiotherapy

Conditions: Head and Neck Neoplasms

Summary: the aim of this study is the evaluation of the frequency of xerostomia and their management after radiotherapy in head and neck cancer. the quality of life of these patients is also analysed with european organization for research and treatment of cancer quality of life questionnaire h\&n35 (eortc qlq h\&n35).


Eligibility criteria:
inclusion criteria: * patient with head and neck cancer after radiotherapy treatment exclusion criteria: * patient already treated for xerostomia for other reason : sjögren's syndrome, medication, diabetes,...

Keywords: xerostomia radiotherapy
ultrasound-guided pulsed radiofrequency for plantar fasciitis

Conditions: Plantar Fasciitis

Summary: although there are many conservative method for plantar fasciitis, patients might spend 2 years to achieve resolution. recent study have shown that pulsed radiofrequency (prf) lesioning of peripheral nerve can alleviate kinds of pain condition. however there are no studies of prf lesioning of the tibial nerve in patients with plantar fascilitis by using ultrasound-guided (ug) techniques.

patients with unilateral plantar fasciitis will be enrolled and randomized into intervention and control group. one dose of sono-guided prf is applied in the intervention group and xylocaine in control group. outcome measurements included visual analog scale (vas)、foot health status questionnaire and the thickness of plantar fascile measured by musculoskeletal ultrasonography at different follow-up frame (4th week, 2nd month, 3rd month after treatment).

Eligibility criteria:
inclusion criteria: * heel pain more than 3 months * age more than 20 year-old * the increased thickness of plantar fascile (\>4mm) measured by sonography * must be conscious * not receive steroid or other injection in plantar fascile in past 6 months exclusion criteria: * cancer of any site * coagulopathy * pregnancy * inflammation status

Keywords: pulsed mode radiofrequency plantar fasciitis ultrasound-guided
investigating the cognitive source of visual working memory impairment in schizophrenia

Conditions: Memory Deficits Schizophrenia Neurostimulator; Complications

Summary: the investigators plan to investigate the effect of enhancement on visual working memory (vwm) in patients of chronic schizophrenia and determine the predictive factors of effective treatment.

schizophrenia is a complex neuro-psychiatric disorder that affects a significant portion of total population worldwide. the disease impairs multiple aspects of human cognition, of which visual working memory (vwm) impairment is known to be one of the pivotal cognitive dysfunction in schizophrenic patients. despite of several attempts that have been made to establish competent treatment strategies to impede cognitive dysfunction of schizophrenia, till date no such studies exhibited satisfactory outcomes. in this context, numbers of studies have been carried out to utilize transcranial direct current stimulation (tdcs) as a treatment option to enhance working memory deficit in various neuropsychiatric populations, but with very limited success. to this end, the present proposal will focus on the use of transcranial alternating current stimulation (tacs) to better target the oscillatory mechanisms underlying vwm. our specific aims are twofold, namely, 1) does dlpfc tacs work on schizophrenic patients in terms of vwm improvement, and 2) how is tacs facilitating patients' vwm? this is because vwm deficit can be caused by poor encoding, poor maintenance, or poor retrieval (or any combination between them). failure at any of those steps will make the patients appear to have poor vwm from clinical observation, but the cognitive process that is impaired may not be the same across populations.

Eligibility criteria:
inclusion criteria: 1. inform consent acquired 2. age 20 to 65 3. right-handed 4. patients with schizophrenia diagnosed according to dsm-5 criteria exclusion criteria: 1. participants who are pregnant or breastfeeding 2. participants who have metal implants 3. participants who have alcohol/substance use disorder or received electro-convulsive therapy within the past 6 months. 4. participants who have history of head injury with loss of consciousness 5. participants who have history of brain lesions, infection, or epilepsy 6. skin lesions on the electrodes placed 7. cancer patients 8. patients with high fever 9. patients with significant sensory loss

Keywords: schizophrenia
development of an assessment tool for health-related quality of life in children and adolescents with pompe disease

Conditions: Pompe Disease

Summary: health related quality of life (hrqol), is "the patient's subjective perception of the impact of his disease and its treatment on his daily life, physical, psychological and social functioning and well-being" and thus constitutes a patient reported outcome (pro) of utmost importance. generic hrqol instruments can by definition not capture disease-specific parameters nor are they sensitive enough to detect their changes. in this study, a disease-specific hrqol questionnaire for children and adolescents will be developed. patients and parents will be involved in focus groups and interviews to identify relevant contents. the instrument will be tested for validity and reliability.


Eligibility criteria:
inclusion criteria: * patients with pd from age 8 years * parent of patient(s) \< 18 years with pd * able to give informed consent as documented by signature * sufficient command of the german language exclusion criteria: * - inability to follow the procedures of the study, e.g. due to language problems or severely reduced health status
study to assess the efficacy, safety, and tolerability of valbenazine for the treatment of dyskinesia due to cerebral palsy

Conditions: Dyskinesia; Cerebral Palsy

Summary: the primary objective of this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in pediatric and adult participants who have dyskinesia due to cerebral palsy (dcp) with choreiform movements.


Eligibility criteria:
key inclusion criteria: 1. medically confirmed diagnosis of dcp (that is, a hyperkinetic movement disorder due to cerebral palsy \[cp\]) with choreiform movements. 2. medical conditions are stable and expected to remain stable throughout the study. key exclusion criteria: participants will be excluded from the study if they meet any of the following criteria: 1. are pregnant or breastfeeding. 2. have a clinical diagnosis or history of dyskinesia due to condition other than cp. 3. have inability to swallow soft foods, unless medications can be administered via gastrostomy/gastrojejunostomy tube. 4. have any suicidal behavior or suicidal ideation in the year prior to screening or on day 1. 5. is a substance abuser of any compound. 6. known history of long qt syndrome or cardiac tachyarrhythmia, or clinically significant electrocardiogram (ecg) abnormalities.

Keywords: cerebral palsy vesicular monoamine transporter 2 (vmat2) inhibitor dyskinesia neurocrine valbenazine nbi-98854 dystonia chorea athetosis athetoid cerebral palsy choreoathetosis
pharmacokinetic (pk) study in japanese non-epileptic renal impaired patients

Conditions: Healthy Subjects; Renal Impairments

Summary: this is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered levetiracetam (lev) in japanese subjects with normal renal function and in japanese subjects with various degrees of impaired renal function.

the primary objective of this study is to evaluate the plasma and urine pk of levetiracetam (ucb l059) and its metabolite (ucb l057) after a single dose of lev 250 mg or lev 500 mg in japanese subjects with normal renal function and in japanese subjects with various degrees of renal impairment.

Eligibility criteria:
inclusion criteria: * healthy subjects with normal renal function * subject is japanese * subjects with creatinine clearance within 1 of 3 groups (clcr\[ml/min/1.73 cm\^2\]: group b: 50 - \<80, group c: 30 - \<50, group d: \<30), or for group e, subjects with end-stage renal failure undergoing hemodialysis exclusion criteria: * subjects has taken any drug treatment, disease or injury to influence levetiracetam pk except for renal impairments

Keywords: levetiracetam oral administration japanese non-epileptic healthy renal impaired subjects
hypophosphatemia deleteriously affects outcome of septic shock patients admitted to icu

Conditions: Effect of Hypophosphatemia on Septic Patients

Summary: patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of developing morbidities other than that underlying sepsis and more vulnerable to higher mortality rate. thus, the current study hypothesized that diagnosis and management of hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to icu

the current study was started since june 2018 till jan 2020 after approval of the study protocol by the local ethical committee. the study intended to include all patients admitted to icu with or developed severe sepsis or septic shock within 24-hr after admission to icu. all patients admitted to icu were eligible to evaluation for demographic and clinical data including hemodynamic data. disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation ii score (apache ii) (20) and sofa (18) scores. exclusion criteria included maintenance on immunodepressent therapy for any indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the written concept for study participation. children and adulthoods younger than 18 years and patients who were expected to die were also excluded from the study.

Eligibility criteria:
inclusion criteria: * all patients admitted to icu were eligible to evaluation for demographic and clinical data including hemodynamic data. * disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation ii score (apache ii) (20) and sofa (18) scores. exclusion criteria: * maintenance on immunodepressent therapy. * severe hemorrhagic shock. * pregnancy * refusal of nearest relative to sign the written concept for study participation.
long-term clinical, immunologic, and virologic profiles of children who received early treatment for hiv

Conditions: HIV Infection

Summary: impaact 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to hiv remission or cure. up to approximately 250 participants will be in the study for approximately seven years. no intervention is provided in the study.

this is an observational prospective cohort study characterizing and establishing a biorepository of early treated children who may participate in future research related to hiv remission or cure. early treatment is defined as treatment with at least three arv agents from at least two classes of art initiated within 12 weeks of birth. within the overall study population, for descriptive and analysis purposes, children who initiated treatment within 48 hours of birth will be classified as having received very early treatment. a subset of children will have received bnabs as part of their treatment regimens. up to approximately 250 children living with hiv who received early treatment in impaact network studies or other research studies sponsored by the us national institutes of health (nih) will be enrolled and followed semi-annually for up to seven years. clinical, virologic, and immunologic evaluations will be performed semi-annually at each study visit, and specimens will be collected for the study's biorepository for future investigations.

Eligibility criteria:
inclusion criteria: * participated in one of the parent studies * confirmed hiv-1 infection based on documented nucleic acid testing of two blood samples collected at different time points * received early treatment for hiv-1 infection, defined as treatment with at least three arv agents from at least two classes of art, initiated within 12 weeks of birth * based on parent or guardian report at entry, child is expected to be available for at least 24 months of follow-up * parent or guardian is willing and able to provide written informed consent for child's study participation and, when applicable per institutional review board/ethics committee (irb/ec) policies and procedures, child is willing and able to provide written assent for study participation exclusion criteria: * has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe or otherwise interfere with completing study procedures
validation and assessment of novel morphology-voltage-p-wave score for diagnosing left ventricular diastolic dysfunction in patients with hypertension

Conditions: Hypertension

Summary: this study aimed to assess and validate the diagnostic utility of a novel morphology-voltage-p-wave score (mvp score) in identifying left ventricular diastolic dysfunction among patients with hypertension. researchers will collect information of patient with hypertension and underwent transthoracal echocardiography assessment. the data consist of demographic data, clinical presentation, laboratory, and echocardiography result were collected by two investigators. then, the data was analyzed by using ibm spss statistics v26.


Eligibility criteria:
inclusion criteria: * essential hypertension exclusion criteria: * secondary or resistant hypertension * lvef\<55% * congenital heart disease * infiltrative cardiomyopathy * coronary artery disease * chronic kidney disease * valvular heart disease * bundle branch block * arrhythmia
pharmacokinetic drug-drug interaction study

Conditions: Chagas Disease

Summary: the purpose of this study is to determine whether benznidazole and e1224 should be administered concomitantly in patients with chagas disease as not enough data are available. this study aims to assess cross interactions of these two compounds.

benznidazole and e1224 are intended to be administered concomitantly in patients with chagas disease. thus, an in vivo interaction study in healthy volunteers may be justified as the two drugs are intended to be administered concomitantly in patients and no in vivo nor in vitro data are available. in addition both interactions (potential for benznidazole to interact on the pharmacokinetic (pk) of e1224 and potential for e1224 on the pk of benznidazole should be studied. benznidazole t1/2 is quite short (12 h) whereas e1224 t1/2 is very long (more than 200 h). therefore it was chosen to study the interaction of e1224 at steady-state while interaction of benznidazole after single dose appears more appropriate instead of a classical randomized cross-over design.

Eligibility criteria:
inclusion criteria: 1. male healthy volunteers 18 to 45 years of age; 2. light smokers (less than 5 cigarettes per day) or subjects who are non-smokers; 3. male subjects with a body weight of at least 50 kg and a body mass index (bmi) calculated as weight in kg/height (in m2) from 18 to 28 kg/m2 at screening; 4. able to communicate well with the investigator and research staff and to comply with the requirements of the entire study; 5. provision of written informed consent to participate as shown by a signature on the volunteer consent form; exclusion criteria: 1. who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected hiv, hepatites b virus (hbv) or hepatites c virus (hcv) infection; 2. who has positive diagnosis of t. cruzi infection indicated by conventional serology; 3. with any clinically significant abnormality following review of pre-study laboratory tests, vital signs, full physical examination and 12-lead ecg; 4. who forfeit their freedom by administrative or legal award or who were under guardianship; 5. unwilling to give their informed consent; 6. who have a positive laboratory test for hepatitis b surface antigen (hbsag), or anti-hiv 1/2 or anti- hcv antibodies; 7. who have a history of allergy (serious or not), allergic skin rash, asthma, intolerance, sensitivity or photosensitivity to any drug; 8. who are known or suspected alcohol or drug abusers (more than 14 units of alcohol per week, one unit = 8 g or about 10 ml of pure alcohol);

Keywords: chagas disease drug-drug interaction benznidazole e1224 pharmacokinetics
temperature monitoring in cardiac surgery: agreement between different clinical methods

Conditions: Temperature Change, Body

Summary: observational study to compare core temperatures obtained by 6 methods in patients undergoing cardiac surgery under cardiopulmonary bypass.

this study compares the core temperatures obtained by means of different probes placed in nasopharinx, pulmonary artery, arterial outlet, venous inlet, bladder and forehead in patients undergoing cardiac surgery under cardiopulmonary bypass.

Eligibility criteria:
inclusion criteria: * only patients requiring a pulmonary artery catheter were included. exclusion criteria: * sepsis or previous fever. * previous bladder catheter without termistor * deep hypothermic circulatory arrest.

Keywords: core temperature cardiac surgery