Kornimate/medical-research-clean huggingface dataset:
study of tenofovir alafenamide in hbv-infected pregnant women

Conditions: Chronic Hepatitis b; Tenofovir Alafenamide Fumarate

Summary: the purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of taf in hbv-infected pregnant women.

pregnant women with high viral load (hbv dna\>2 × 10\^5 iu/ml ) are recommended to be given tenofovir disoproxil fumarate(tdf) for mother-to-child blocking of chronic hepatitis b(chb) by guidelines. tenofovir alafenamide (taf) is a new targeted pro-drug of tenofovir (tfv) and was approved for use in china in december 2018. compared with tdf, the therapeutic dose of taf is small. 25mg taf can obtain the antiviral effect similar to 300mg tdf, thus reducing the concentration of tfv in the blood. this is a prospective clinical study, aiming to evaluate the pharmacokinetics, efficacy and safety of taf in hbv-infected pregnant women when used for prevention of mother-to-child transmission of hepatitis b virus. 50 hbeag-positive and hbv dna levels ≥ 2 × 10\^5 iu/ml pregnant women will be enrolled to receive tenofovir alafenamide (taf) from week 28-32 of gestation until delivery. according to the mother's wishes, intensive blood samples will be collected to determine the concentration of taf and tfv in plasma of pregnant women before and after taking taf, calculate the pharmacokinetic parameters. and the mother's milk is collected every day for 5 days for taf concentration determination. the primary endpoint was the pharmacokinetic parameters of taf and tfv, rate of mother-to-child transmission, the congenital malformation rate of infants. the secondary endpoint was the decrease of hbv dna level at delivery, the clearance and seroconversion rate of hbeag, postpartum alt flare, concentration of taf and tfv in milk,and other adverse events of mothers and infants.

Eligibility criteria:
inclusion criteria: * age of 20-40 years; positive for hepatitis b surface antigen (hbsag) and hepatitis b virus e antigen (hbeag); hbv dna level \>200 000 iu/ml during the 24th-32nd week of pregnancy; willing to take taf for mother-to-child blockade; both husband and wife are willingly sign an informed consent. exclusion criteria: * co-infected with hepatitis c or hiv, or other chronic diseases; history of spontaneous abortion or congenital malformation; decompensated cirrhosis and liver cancer; history of kidney injury, ccr \ 300mg/l); fetal malformations detected by b-ultrasound during pregnancy; alt \> 2×upper limit of normal (uln); tbil ≥ 1×uln; albumin (alb) \< 25 g/l.

Keywords: pharmacokinetics chb taf pregnancy mother-to-child transmission
evaluation of the therapeutic effect of hu pulse therapy for cml patients

Conditions: Leukemia, Chronic Myeloid

Summary: rationale: drugs used in chronic-phase chronic myelogenous leukemia (cml) aimed to avoid cml conversion (ap, bc). hydroxyurea pulse therapy for chronic-phase cml patients is effective based on the investigator's previous studies, and the scheme cost lower than imatinib. it is not yet known the efficacy compared hydroxyurea pulse therapy with imatinib for chronic-phase cml, especially to achieve hematological remission in short time. purpose: non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with that of imatinib in treating chronic-phase cml patients.

objectives: i. compare the time of wbc decreased by 10%,20%,30%,50% of these patients treated with these two drugs. ii. compare the time of spleen size decreased by 10%,20%,30%,50% of chronic-phase chronic myelogenous leukemia patients treated with imatinib to those treated with hydroxyurea pulse therapy. iii. compare the time to achieve complete remission (cr) of these patients treated with these two drugs. iv. estimate the overall survival, event-free survival, progression-free survival (os, efs, pfs) and major cytogenetic response of these patients treated with these two drugs. outline: patients are to receive one of two treatments. arm i: induction: patients receive oral hydroxyurea daily (hydroxyurea pulse therapy) until hematological remission. maintenance: continuing hydroxyurea pulse therapy to maintain white blood cells below 8. 0 × 109 / l. arm ii: induction: patients receive imatinib 400mg qd until acceptable blood counts are achieved. maintenance: follow the recommendations of the nccn guidelines for chronic-phase cml treatment. projected accrual: a total of 60 patients (30 per arm) will be accrued for this study within 2 years.

Eligibility criteria:
inclusion criteria: 1. diagnosis of chronic myelogenous leukemia (cml) in chronic phase. patients in either accelerated or blastic phases are not eligible. 2. no previous therapy with any drugs. 3. age ≥ 16 years 4. patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible. 5. non-pregnant and non-nursing. treatment under this protocol would expose an unborn child to significant risks. women and men of reproductive potential should agree to use an effective means of birth control. exclusion criteria: 1. patients treated with any chemotherapy drugs. 2. patients younger than 16 years.

Keywords: leukemia, myeloid, chronic-phase hydroxyurea imatinib mesylate pulse therapy, drug
lokomat versus strength training in chronic incomplete spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of this pilot study is to investigate whether gait specific robotic supported bodyweight supported treadmill training and lower extremity strength training have similar beneficial effects on walking function and other outcomes.

although task-specific training has been promoted during the last years to improve function, recent studies showed that after an incomplete spinal cord injury, strength, but not complex movement coordination, is affected. in this randomized cross-over trial we investigate the effectiveness of a task-specific 4 week lokomat training with a 4 week (unspecific) lower extremity muscle strength training on walking-related and other outcomes.

Eligibility criteria:
inclusion criteria: * time since lesion \> 1 year * outdoor mobility scim iii \< 5 * stable walking capacity exclusion criteria: * participating on other training studies * osteoporosis * psychiatric diseases * epilepsia * body weight \> 130 kg * cardiac pacemaker

Keywords: asia c and d
survivorship and patient outcomes of primary total hip arthroplasty with the ovation hip system

Conditions: Joint Diseases; Osteoarthritis, Hip; Rheumatoid Arthritis; Psoriatic Arthritis; Avascular Necrosis of Hip

Summary: the objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the clinical evaluation report for the ortho development hip system.

long term surveillance of survivorship and complications can help to identify pre-surgical comorbidities, perhaps leading to a lower risk of implant failure and subsequent revision surgery. by understanding the role of comorbidities in the specific population, it is possible to increase patient outcomes and satisfaction, while reducing the costs associated with complications and revision surgeries. this study consists of prospective collection and analysis of data for a consecutive series of patients that underwent total hip arthroplasty with the ortho development ovation® hip system at the study site between 2012 and december 2015. it is estimated that over 400 patients received the subject system. each of these patients will receive a survey within the mail when they approach, or have exceeded, their five-year post-surgical time period.

Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * patient is five years post total hip arthroplasty * patient received the ovation® or ovation tribute® femoral stem with associated acetabular and femoral components * patient agrees to participate in the survey. exclusion criteria: * patient does not have the ovation® or ovation tribute® femoral stem with associated acetabular and femoral components
long-term follow-up of lichtenstein's operation versus mesh plug repair

Conditions: Inguinal Hernia

Summary: long-term follow-up of a randomized clinical trial of lichtenstein's operation versus mesh plug for inguinal hernia repair based on the following published study "randomized clinical trial of lichtenstein's operation versus mesh plug for inguinal hernia repair. br j surg. 2007 jan;94(1):36-41." primary endpoints is recurrence.


Eligibility criteria:
inclusion criteria: * 40 years and older, patients who became 40 in the year of the operation were included (6 patients younger than 40 years were included because of explicit patient's wish). * provision of written informed consent, * symptomatic unilateral or bilateral inguinal hernia. exclusion criteria: * presence of a femoral hernia, * history of hernia repair with mesh, * type i diabetes, * presence of local or diffuse infection (urine, skin, lung, sepsis), * immune deficiency, * severe medical problems contraindicating safe induction of general anaesthesia or elective surgery, * pregnancy, * malignant tumours and * life expectancy of less than 2 years

Keywords: inguinal hernia repair long-term follow-up surgical technique
application of stress ball and non-stress test with pregnant women

Conditions: Anxiety; Pregnancy Related

Summary: this research was planned as a randomized controlled experimental study to reduce the anxiety expectant mothers feel when on a non-stress test.

fetal well-being is assessed by evaluating fetal heart rate (fhr) patterns. the primary aim is to identify fetuses at risk of intrauterine death or neonatal complications and, if possible, intervene (usually by delivery) to prevent these adverse outcomes. the most commonly used method for this purpose is the non-stress test. non-stress test (nst) is a non-invasive fetal evaluation method. the nst is evaluated for at least 20 minutes while the expectant mother is lying supine or left-side. although it is a painless procedure, it takes about 20 minutes, and the pregnant woman stays in the same position throughout the procedure, creating although there are many methods to reduce stress, it is thought that a cheap and easily accessible stress ball can be used as a method of distraction or distraction. although there are studies investigating the effectiveness of stress balls in managing various disease groups and symptoms in the literature, no study has been found to examine the nst effectiveness of stress balls. this research was planned as a randomized controlled experimental study to reduce the stress felt by women who had a non-stress test during pregnancy by applying a stress ball during the procedure. anxiety for the pregnant woman. the fact that the pregnant woman has high anxiety during the procedure affects the test result and may increase the false-positive rate and cause false evaluation. this increase in the false-positive rate in nst results may lead to an increase in an operative delivery. however, it is the midwives' responsibility to eliminate the situations that cause anxiety in pregnant women, which may affect the nst result before and during the procedure.

Eligibility criteria:
inclusion criteria: * ability to read and understand turkish * being between the ages of 20-35 * single pregnancy * having had nst before ¬- have eaten at least 2 hours before the nst procedure * don't be primiparous * getting 37 or less on the trait anxiety (stai-1) scale * getting 37 or more on the state anxiety (stai-2) scale * volunteering to participate in the research * fully answering survey and scale forms * being in the 3rd trimester exclusion criteria: * having been diagnosed with a risky pregnancy * unwilling to continue working * having a chronic disease (diabetes, hypertension, thyroid etc.), * having any problem that prevents communication (such as hearing, speaking, and understanding abilities), * using one of the pharmacological or non-pharmacological methods to reduce stress and receiving psychiatric treatment (pharmacotherapy or psychotherapy).

Keywords: anxiety pregnancy stress ball non-stress test
safety of early removal of chest tubes after thoracoscopic lung biopsies

Conditions: Non-Neoplastic Thoracic Disorder; Lung Diseases

Summary: prospective study, involves 60 patients underwent thoracoscopic surgery, the patients will be divided into two groups, the first group will undergo early chest tube removal - after three hours, the second group will have late chest tube removal according to the department's protocol. the study aims to prove the possibility and non inferiority for early chest tube removal for thoracoscopic surgeries with non complicated surgical course.

presence of chest tube post thoracoscopic surgery is associated with increased morbidities like wound infection, pain, and prolong the hospital admission corse, in the other hand, early chest tube removal is associated with increased the need for recurrent active intervention like pleural tapping for re-accumulated pleural effusion. method: randomized prospective study includes 60 patients who underwent thoracoscopic lobectomy/segmentectomy/ thoracoscopic mediastinal biopsy. the study will exclude patients with difficult operative course ( intraoperative finding of significant adhesions/ intraoperative injury of the lung parenchyma/ intraoperative bleeding/failure of extubation ) and patient with post operative findings of ( bleeding in the chest tube more than 100 ml in the first hour, persistent air leak, non expanded lung on chest x-ray ) the patients will be divided into two groups, the first group - 30 patients - will undergo chest tube removal after three hours, and the second group will undergo chest tube removal according to the treating department protocol. all patients will be evaluated regarding the pain level - subjective and objective -, admission period, infection, and the need for invasive intervention. the patients will be evaluated during the admission, after one week and after two weeks.

Eligibility criteria:
inclusion criteria: * patient's who undergo thoracoscopic lung resection ( lobectomy or segmentectomy ), or thoracoscopic mediastinal biopsy. * post op there was no bleeding, the lung expanded, no persistent air leak, fluid discharge in the chest tube less than 100 ml, the patient underwent extubation. * patients with who read and signed informed consent regarding the participation of the study. exclusion criteria: * patients who underwent thoracoscopic segmental resection due to primary spontaneous pneumothorax. * patients who underwent thoracoscopic pleural biopsy for possible malignancy. * patients under 18 year old.
nitric oxide bioavailability and early life stress (no-stress)

Conditions: Cardiovascular Disease

Summary: cardiovascular disease is the leading cause of death in the united states. other studies have shown that stress, early in life, could be a risk factor for cardiovascular disease, later in life. this study will look at the effect of early life stressors on your cardiovascular health.

this study will have two parts involved to investigate the role that childhood ses status has on cardiovascular health. part one: subjects will give a blood sample which will be processed and analyzed. flow mediated dilation (fmd) and pulse wave velocity (pwv/pwa) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg of vitamin c, 600 iu of vitamin e, and 600 mg of alpha-lipoic acid) or placebo on two days separated by at least 72 hours. nitroglycerin mediated dilation (nmd, 0.4mg sub-lingual nitroglycerin spray), will be assessed at baseline. part two: subjects, if interested will undergo a subcutaneous gluteal/hip fat biopsy. micro vessels will be isolated from the adipose tissue and analyzed by pressurized myography for endothelial function and nitric oxide bioavailability.

Eligibility criteria:
inclusion criteria: * documented childhood ses * men and premenopausal women ages 18-40 * lean/overweight/or obese with bmi\< or equal to 39kg/m2 exclusion criteria: * cardiovascular, renal, pulmonary, hepatic, cerebral, or metabolic,disease * use medications that affect vascular tone * post menopausal women * have class 3 obesity or bmi over 40

Keywords: low childhood ses early life stress endothelial function flow mediated dilation cardiovascular disease subcutaneous adipose arterioles
diurnal variation in tear osmolarity

Conditions: Dry Eye Disease

Summary: the purpose of this study is to measure the change in tear osmolarity during the course of the day to support clinical diagnosis of aqueous deficiency or meibomian gland disease and differentiate between the two forms of dry eye.

the premise of this study is that dry eye disease, specifically tear osmolarity, changes during the course of the day based on the etiology of the dry eye and that aqueous-deficiency dry eye will worsen during the course of the day while meibomian gland deficiency will stabilize or possibly even improve during the course of the day.

Eligibility criteria:
inclusion criteria: 1. healthy males and females ≥ 18 years old 2. negative urine pregnancy results for females of childbearing potential 3. able to read and sign an informed consent form and show willingness to comply with the study protocol visits and procedures 4. has 20/40 bcva or better in at least one eye 5. does not currently wear contact lenses 6. for aqueous-deficiency group: * has symptoms of dry eye * schirmer testing ≤ 10 mm * tear break up time ≤ 8 seconds * conjunctival staining ≥ 1+ * meibomian gland inspissations ≤ 1+ * no lid thickening, lid erythema, or thickened, turbid meibomian gland secretions 7. for meibomian gland disease group: * has symptoms of dry eye * schirmer testing ≥ 10 mm * tear break up time ≤ 8 seconds * conjunctival staining ≥ 1+ * meibomian gland inspissations ≥ 2+ 8. for normal group: * has no symptoms of dry eye * schirmer testing \> 10 mm * tear break up time \> 8 seconds * no or trace conjunctival staining * no meibomian gland inspissations exclusion criteria: 1. any topical medication within the last three months, except for artificial tears 2. unable to discontinue use of artificial tears during the course of the day for visit 2 3. any systemic disease, which in the opinion of the investigator, may affect ocular health or confound study results 4. any active ocular disease other than dry eye disease, meibomian gland disease or sjogren's syndrome, which in the opinion of the investigator, may affect ocular health or confound study results 5. clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities 6. clinically significant limbal or bulbar injection, or corneal staining not due to des 7. has worn hard or rigid gas permeable contact lenses within 1 year 8. has worn soft contact lenses within 1 week 9. has had eye surgery or an eye injury within 6 months 10. positive urine pregnancy results for females of childbearing potential 11. any changes in current medication within 30 days of visit 2 or anticipated change during course of study, which in the opinion of the investigator may confound study results

Keywords: dry eye tear osmolarity meibomain gland disease aqueous dificiency tear film abnormality
feasibility study on the effect of complementary methods as supportive interventions for parents of children with cancer

Conditions: Anxiety; Stress; Mood; Coping

Summary: the purpose of this study is to determine whether guided imagery and progressive muscle relaxation are effective as stress reducing techniques in parents of hospitalized children with cancer.

having a children with cancer can be a source of stress for parents during hospitalization. the stress experienced by the parents can negatively influence their functionality, daily activities, psychological state and also their physical condition. the studies in the literature have mainly focused on the child rather than the parent, and studies specifically for guided imagery are scarce. since the parents are often neglected by the healthcare professionals during the stress evoking period of hospitalization, this study will test the effectiveness of complementary methods in improving the psychological state of the parents.

Eligibility criteria:
inclusion criteria: * willingness to participate * having a child with childhood cancer been hospitalized for 4 weeks * have a child (0-18) of age with childhood cancer * able to speak and write greek fluently * no previous experience with cam techniques exclusion criteria: * receiving drug therapy for stress * using another cam technique during the study * parents of children receiving palliative care

Keywords: parent childhood cancer complementary and alternative
use of continuous glucose monitors in coronavirus disease 2019 icu and potential inpatient settings

Conditions: Covid19; Diabetes Mellitus

Summary: the objective of the study is to improve glycemic control in inpatient/icu settings using real- time continuous glucose monitors (cgm) data for insulin titration. it may help reduce coronavirus disease 2019 patient contact with healthcare workers as well.

due to the increasing need for acute care of covid-19 patients in icu settings, the use of continuous glucose monitors (cgm) as a means to reduce patient contact and remotely improve glycemic control for diabetic covid-19 patients needs to be explored. as demonstrated by recent data published in china, wuhan province patients with diabetes made up 22.2% of covid-19 icu patient populations with a subsequent mortality of 7.3% (3). not only during covid-19 pandemic but also previous experiences with sars and influenza viral respiratory infections demonstrated increased mortality in those patients with hyperglycemia (4). using cgms provides timely access to glucose trends, commonly used to determine insulin dosing decisions in outpatient settings (5). implementing their use for hospitalized patients could be expected to improve healthcare worker insight into glycemic control therapies. considering the ease of transmission of the sars-cov-2 virus, it is important to minimize duration and frequency of patient contact in order to maintain the safety of covid-19 healthcare workers without compromising on their glycemic control. the who recommends that any healthcare provider coming into direct contact with covid-19 patients should be utilizing appropriate ppe for each encounter. in this time of limited ppe supply (6), remote glucose monitoring can allow for rational use of these limited resources. with appropriate training on cgm data interpretation, nursing and ordering providers could expect to develop and implement more efficient insulin plans, requiring fewer physical contact with covid-19 positive patients.

Eligibility criteria:
inclusion criteria: * coronavirus disease 2019 tested positive patient * age over 18 years * admitted to coronavirus disease 2019 specific icu, with possible transfer to inpatient unit when stable * patients with known or acquired type 1 or type 2 diabetes requiring insulin therapy during admission exclusion criteria: * in state of active diabetic ketoacidosis (dka) at time of enrollment * two or more vasopressors in use at time of sensor placement * unable to use at predetermined sensor site based on assessment of skin health
reduction of immunization discomfort in children

Conditions: Pain

Summary: a combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged children.

randomization of 42 children evaluated the method described above against an office routine control group.

Eligibility criteria:
inclusion criteria: * all children ages 4-6 years scheduled to receive routine pre-kindergarten immunizations exclusion criteria: * inability to follow verbal directions * significant concurrent illness * prior invasive procedures, excluding neonatal circumcision

Keywords: immunizations children injections aged 4-6 years hypnosis