Kornimate/medical-research-clean huggingface dataset:
positive airway pressure treatment of obstructive sleep-disordered breathing in hypertensive disorders of pregnancy

Conditions: Hypertensive Disorder of Pregnancy; Sleep Apnea, Obstructive

Summary: the purpose of this study is to conduct a pilot randomized, controlled trial to evaluate the feasibility and obtain pilot outcome data for a subsequent definitive trial evaluating the effects of postitive airway pressure (pap) treatment of obstructive sleep-disordered breathing (osdb) on blood pressure control and maternal and fetal outcomes in hypertensive disorders of pregnancy. the primary aim of the pilot study is to assess feasibility measured as the rates of subject recruitment, adequate (\>4h/night) pap adherence (primary outcome measure) and protocol completion. secondary aims will be to obtain preliminary data on the effects of pap on maternal blood pressure, complications of hypertension, arterial stiffness and vascular biomarkers, course of labor and delivery and fetal outcomes including growth restriction, prematurity, and neonatal distress.


Eligibility criteria:
inclusion criteria: * ≥ 18 y with a singleton pregnancy, ≥ 12 weeks' gestation * diagnosis of hypertensive disorder of pregnancy, including pre-existing hypertension, gestational hypertension and pre-eclampsia, as defined by canadian hypertensive disorders of pregnancy working group criteria (magee et al; best practice and research clinical obstetrics \& gynaecology. 2015;29(5):643-657) * presence of obstructive sleep-disordered breathing (osdb) on a single night in-home complete (level 2) polysomnogram defined by an apnea-hypopnea index (ahi) ≥ 5 events/h and/or the presence of inspiratory flow limitation on ≥ 30% of breaths. exclusion criteria: * severe pre-eclampsia/eclampsia requiring urgent delivery * chronic kidney disease or other secondary cause of hypertension * known cardiac disease, transient ischemic attack/stroke * malignancy or other chronic medical or psychiatric condition * smoking, alcohol use, illicit drugs * current/recent treatment for sleep-disordered breathing * severe sleep-disordered breathing defined as an apnea-hypopnea index (ahi) ≥ 30/h with either severe sleepiness (epworth sleepiness score ≥ 15) or hypoxemia (4% oxygen desaturation index ≥30/h or arterial oxygen saturation (spo2) \ 10% of total sleep time)

Keywords: gestational hypertension pre-eclampsia eclampsia obstructive sleep apnea-hypopnea positive airway pressure polysomnography blood pressure arterial stiffness
the reliability, validity, and responsiveness of the timed 360° turn test in patients with multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the aim of the study is to investigate reliability, validity, and responsiveness of the timed 360° turn test in patients with multiple sclerosis.

at baseline, the timed 360° turn test, berg balance scale, timed up and go test, functional reach test, four square step test, and one-legged stance test is applied to the multiple sclerosis group. the timed 360° turn test is repeated after seven days from the first application in patients with multiple sclerosis. healthy controls are going to perform only the timed 360° turn test.

Eligibility criteria:
inclusion criteria: * at least 18 years, * neurologist-diagnosed multiple sclerosis, * expanded disability status scale (edss) score \< 7, * able to walk 20 m with or without aids, * no ms exacerbation within the last 2 months, * use of stable medication in the last 2 months. exclusion criteria: * other neurologic disorder, * pregnancy, * orhopedic problems affecting gait and stance, * visual, auditory, orientational problems that could affect study results, * cardiovascular, pulmonary, and humoral disease.

Keywords: the timed 360° turn test multiple sclerosis reliability validity
68ga-bnota-prgd2 pet/ct in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is an open-label positron emission tomography/computed tomography ( pet/ct) study to investigate the diagnostic performance and evaluation efficacy of 68ga-bnota-prgd2 in rheumatoid arthritis (ra) patients. a single dose of nearly 111 mbq 68ga-bnota-prgd2 (≤ 40 µg bnota-prgd2) will be intravenously injected into patients with ra. visual and semiquantitative method will be used to assess the pet/ct images. whole body 18f-fdg pet/ct will be performed for comparison.

the alpha(v)beta3 integrin, one of the most prominent members of integrin superfamily, is trans-membrane heterodimeric proteins which mediate cell-cell and cell-extracellular matrix adhesion. integrin alpha(v)beta3 receptor plays an pivotal role in promoting, sustaining and regulating the angiogenesis and was identified as a marker of angiogenic vascular tissue. cyclic arginine-glycine-aspartic acid (rgd) peptides was identified as a key integrin recognition motif which could strongly bind to integrin alpha(v)beta3 and inhibit new blood vessel formation. animal study in antigen induced arthritis demonstrated that intra-articular administration of a cyclic rgd antagonist of alpha(v)beta3 leading to inhibition of cell infiltrate, synovial angiogenesis, pannus formation, cartilage erosions and even diminishing arthritis severity. for these properties, rgd peptide-based multimodality molecular probes have been developed for noninvasive imaging by targeting integrin alpha(v)beta3. and compared with 18f-fdg pet/ct, radiolabeled rgd imaging is a promising approach to visualize angiogenesis and provide a therapeutic target for anti-angiogenetic and anti-integrin therapy. for the further interests in clinical translation of 68ga-bnota-prgd2, an open-label pet/ct study was designed to investigate the diagnostic performance and evaluation efficacy of 68ga-bnota-prgd2 in ra patients.

Eligibility criteria:
inclusion criteria: * patients fulfilled the 1987 revised criteria of the american college of rheumatology (acr) for ra; * males and females, ≥18 years old exclusion criteria: * concurrent medical conditions of other autoimmune diseases * latent or active joint infection or joint injury * renal dysfunction (serum level of creatinine more than 1.2 mg/dl) * females planning to bear a child recently or with childbearing potential * known severe allergy or hypersensitivity to intravenous radiographic contrast * inability to lie still for the entire imaging time because of cough, pain, etc * inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc * concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance

Keywords: rheumatoid arthritis angiogenesis 68ga-prgd2 18f-fdg positron emission tomography/computed tomography
microinvasive glaucoma surgery -the lowering effect of intraocular pressure on glaucoma patients with high frequency deep sclerotomy

Conditions: Primary Open Angle Glaucoma; Intraocular Pressure; Glaucoma Surgery

Summary: highlights the high-frequency deep sclerotomy (hfds) as a promising ab-interno surgery in primary open-angle glaucoma (poag) patients and evaluates the eﬃcacy and safety of the procedure.

\[materials and methods \] this is a single-centre, prospective, non-blinded, interventional trials designed to evaluate the therapeutic effect and safety of hfds in poag patients. a total of 30 subjects were recruited, all of whom were outpatients of the ophthalmology department of attending physician meilan ko in the national taiwan university hospital hsin-chu branch. the 20 subjects were all diagnosed with poag. the surgery was performed in the surgery room of the national taiwan university hospital hsin-chu branch. the surgery was performed using the abee® glaucoma tip of oertli phacoemulsiﬁcation machine (cata-rhex3, switzerland) and goniolens. during the procedure, nasal six pockets penetrating 1mm deep into the trabecular meshwork and schlemm's canal were formed to promote aqueous humor outflow. \[postoperative follow-up and evaluation\] the postoperative iop and visual acuity (va) were measured in every follow-up visit for 6 months. postoperatively, cravit/lotemax drops were given to prevent inflammation and infections; besides, pilocarpine 2% eye drops were provided to reduce iop for postoperative medication. \[data statistics and analysis\] statistical analysis was done by ibmspss v21.0 statistical software (ibm corporation, new york, usa). data analysis was done by chi square (χ2) test, paired samples t-test and repeated anova measurements with bonferroni post hoc analysis. the results are considered statistically signiﬁcant with a p value \<0.05.

Eligibility criteria:
inclusion criteria: * patients with chronic open angle glaucoma and were indicated for surgery due to either progression of field defect and raised intraocular pressure above 21 mmhg in spite of maximum medical treatment or for patients who were not compliant patient to their medical treatment. exclusion criteria: * patients with close-angle, congenital, traumatic, neovascular, and uveitic glaucoma, patients with prior penetrating and nonpenetrating glaucoma surgeries or laser therapy, and eyes with corneal opacity precluding visualization of the angle.

Keywords: primary open angle glaucoma high frequency deep sclerotomy abee glaucoma tip of oertli
initiative for patient outcomes in dialysis - peritoneal dialysis (pd) (ipod-pd study)

Conditions: Chronic Renal Failure

Summary: the aim of the study is to asses the hydration status of incident peritoneal dialysis (pd) patients and its evolution over a period of four years, independent of the pd treatment modality (apd or capd) and the pd solution type.

achieving optimal fluid balance remains a major clinical challenge in peritoneal dialysis (pd) patients. with the recent development of a new bioimpedance spectroscopy (bis) device, the bcm-body composition monitor (bcm), it is now possible to quantify deviations of hydration status and to define target weight directly. it has been observed that more than 50% of the pd patients are overhydrated, as compared to the healthy population. this overhydration seems to be associated with modifiable practice-related factors, such as correct pd prescription according to membrane transport status, and dietary fluid intake. the aim of this study is to assess the hydration status of incident pd patients, and diagnose the underlying reasons for incorrect fluid status. in addition, changes in fluid status, residual renal function and nutritional status, over a follow-up period of up to four years will be registered. the investigators assume that the use of the bcm-body composition monitor (bcm) provides quantitative measurement of hydration status and thereby supports physicians in identifying patients who are not euvolaemic. hence, the bcm allows an improved management of underlying causes of non-euvolaemic hydration state and appropriate monitoring of fluid status.

Eligibility criteria:
inclusion criteria: * incident patients directly before start of peritoneal dialysis * patients in whom routine measurement of body composition monitoring is performed exclusion criteria: * patients treated with hd before start of pd * patients in whom body composition monitoring cannot be performed

Keywords: peritoneal dialysis hydration status residual renal function bioimpedance spectroscopy body composition monitor
stella 2 trial: transperitoneal vs. extraperitoneal approach for laparoscopic staging of endometrial/ovarian cancer

Conditions: Endometrial Neoplasms; Ovarian Neoplasms

Summary: the purpose of this study is to determine whether or not there are more complications in the extraperitoneal compared with the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer


Eligibility criteria:
inclusion criteria: * diagnosis of endometrial cancer confirmed by histopathological analysis (endometrial biopsy) requiring surgical staging according to figo (the international federation of gynecology and obstetrics) recommendations * diagnosis of ovarian cancer confirmed by histopathological analysis after an initial cystectomy or oophorectomy without suspicion of neoplasia thus requiring additional surgical staging according to figo recommendations exclusion criteria: * diagnosis of advanced endometrial cancer based on findings on imaging techniques (ct, mri and/or pet) * diagnosis of advanced endometrial or ovarian cancer based on intraoperative findings (e.g. peritoneal carcinomatosis at initial laparoscopy) * patients who underwent previous aortic lymphadenectomy * patients who received previous pelvic and/or aortic radiotherapy

Keywords: extraperitoneal transperitoneal laparoscopic aortic lymphadenectomy endometrial cancer ovarian cancer surgical staging
left ventricular global longitudinal strain and postoperative myocardial injury

Conditions: Postoperative Complications

Summary: to use left ventricular global longitudinal strain as a means of monitoring myocardial exercise function during anaesthesia in patients with coronary artery disease, to explore the association with the occurrence of postoperative myocardial injury, and to perform a predictive study of postoperative myocardial injury. the study was designed according to a prospective follow-up cohort.

the incidence and risk of postoperative myocardial injury in patients with coronary artery disease is high, and there is no definitive monitoring tool to predict postoperative myocardial injury. speckle tracking imaging (sti), which quantifies strain and ventricular torsion in all segments of the heart, is more sensitive to subtle changes in myocardial contractility than conventional ultrasound. this project proposes to use 4d-sti as a means of monitoring myocardial exercise function during anaesthesia in patients with coronary artery disease, to explore the association with the occurrence of postoperative myocardial injury, and to perform a predictive study of postoperative myocardial injury. the study was designed according to a prospective follow-up cohort. the protocol was developed with reference to the strobe guidelines for cohort studies. in this study, 2.5 ml of venous blood specimens were collected before surgery and at the end of surgery and sent to the laboratory. intraoperative data collection was performed in the operating theatre and follow-up was obtained on the ward and during telephone follow-up.

Eligibility criteria:
inclusion criteria: 1. age 65-90; 2. according to the european heart association's diagnostic criteria for chronic coronary syndrome in 2019.patients with suspected coronary heart disease and stable angina pectoris, with or without dyspnea; new heart failure or left ventricular dysfunction, suspected coronary heart disease; patients with acute coronary syndrome who are asymptomatic or stable within one year of onset, or who will undergo revascularization in the near future;patients with an initial diagnosis or revascularization for more than one year, with or without symptoms; angina pectoris, suspected vasospasm, or microvascular disease patients; during screening, asymptomatic people with coronary heart disease were discovered; 3. asa ii\~iii; nyha ii\~iii; require general anesthesia; 4. no history of anesthetic allergy; 5. agreed to participate in the study and signed the informed consent form. exclusion criteria: 1. congenital heart disease, severe ventricular arrhythmia, atrial fibrillation, severe valvular regurgitation; 2. severe history of chronic obstructive pulmonary illness (copd severity iii or iv), individuals with severe or uncontrolled bronchial asthma, pulmonary infection, bronchiectasis; 3. patients with persistent drinking and known or suspected abusers of other narcotic analgesics; 4. obese (bmi 30 kg/m2) 5. cardiac surgical procedures are planned.
a study to explore prognoses of the patients with n2 non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with n2 non-small cell lung cancer

the trial is a multi-centre real-world non-interventional observational study. the chinese patients with n2 non-small cell lung cancer enrolled from 2014 to 2017 who received radical resections of lung cancer and adjuvant chemotherapies will be included in the study and the study data on patient demographic/tumor biological characteristics and clinical treatment will be collected to evaluate compare effectiveness of radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies after surgeries.

Eligibility criteria:
inclusion criteria: * patients with radical resection of lung cancer enrolled from 2014 to 2019; * pathologically diagnosed patients with non-small cell lung cancer; * patients with age \> 18 years old; * patients who did not receive chest surgeries before hospitalization; * patients with n2 lymph nodes (+) after surgeries; * patients who received lymphadenectomy for one group or more groups of lymph nodes; exclusion criteria: * patients with second primary tumors or multiple primary tumors;

Keywords: chinese real-world evidences nsclc surgeries
tenofovir in late pregnancy to prevent vertical transmission of hepatitis b virus

Conditions: Hepatitis B Infection; Chronic Infection; Viremia

Summary: immunoprophylaxis failure of hepatitis b virus (hbv) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis b e antigen (hbeag) positive mothers with high levels of hbv dna. maternal hbv dna \> 6log10 copies/ml (or \>200,000 iu/ml) is the major risk for the mother-to-child transmission. prior observational studies have shown that antiviral therapy including lamivudine or telbivudine use during late pregnancy can safely reduce the rate of vertical transmission in this special population compared to untreated patients. tenofovir disoproxil (tdf), a pregnancy category b medication, reduces hbv dna and normalizes serum alanine aminotransferase (alt) in chronic hepatitis b patients (chb) with few adverse effects. two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study: 1. the data on its tolerability and safety in hbeag+ pregnant women with hbv dna \> 6log10 copies/ml (or \> 200,000 iu/ml) during late pregnancy and infants. 2. its efficacy in the reduction of hbv vertical transmission rate.

eligible mothers will be randomized (1:1) to either tdf-treated group or untreated group with about 100 subjects in each arm. the treatment group will receive tdf starting at week 30-32 of gestation until week 4 postpartum; follow up will continue until post-partum week 28 and infants age of 28 weeks. untreated group will receive the standard of care with similar follow-up schedule as the treatment group.

Eligibility criteria:
inclusion criteria: * documented chb infection with hbsag positive \> 6 months * hbeag+ chb pregnant women * gestational age between 30-32 weeks * hbv dna \> 6 log10 copies/ml (or \>200,000 iu/ml) * both mother and father of the child are willing to consent for the study major exclusion criteria: * co-infection with hepatitis a, c, d, e, hiv-1 or sexually transmitted disease (std) * decompensated liver disease or significant co-morbidity * history of abortion, or diagnosis of fetal defect, or congenital malformation in prior pregnancy * antiviral used within six months prior to this pregnancy, or history of renal or tubular function impairment due to adefovir. * requirement for other medication during pregnancy to manage other chronic disease(s) or concurrent treatment with immune-modulators, cytotoxic drugs, or steroids * the biological father of the child had chb * clinical signs of threatened miscarriage in early pregnancy * evidence of hepatocellular carcinoma * maternal alanine aminotransferase (alt) \> or = 5 x upper limit of normal (u/ml), or total bilirubin \> or = 2, or glomerular filtration rate (gfr) \< 100, or albumin \< 25 g/l * evidence of fetal deformity by ultrasound examination * patient is participating other clinical study

Keywords: hepatitis b vertical transmission pregnancy antiviral treatment
effects of exercise training in chronic obstructive pulmonary disease versus alpha-1-antitrypsin-deficiency-patients

Conditions: Chronic Obstructive Pulmonary Disease; Alpha-1-antitrypsin-deficiency

Summary: chronic obstructive pulmonary disease (copd)-patients (caused by smoking-level) and alpha-1-antitrypsin-deficiency patients showed different developments during rehabilitation in regard to improvement of 6-minute-walking distance. the aim of this study is to investigate differences between training adaptations in copd-patients and alpha-1-deficiency patients. both groups take part in a standardized multimodal 3-week-rehabilitation with strength and endurance training. in addition to conventional diagnostic procedures, muscle biopsies from the m. vastus lateralis will be conducted before and after rehabilitation program followed by biochemical, histochemical and immunohistochemical analysis of the probes.


Eligibility criteria:
inclusion criteria: * copd * alpha-1-antitrypsine-deficiency, phenotype: zz * fev1%pred. \<50 exclusion criteria: * acute exacerbation * exacerbation in the last 4 weeks

Keywords: alpha-1-antitrypsin-deficiency copd exercise training muscle biopsy
study comparing foster efficacy maintenance and reliever versus foster maintenance + salbutamol reliever in asthmatics

Conditions: Asthma

Summary: double-blind, multinational, multicentre, randomized, 2-arm parallel-group study

to compare efficacy of foster as maintenance therapy plus additional inhalations as reliever with foster as maintenance plus salbutamol as reliever in asthmatics

Eligibility criteria:
inclusion criteria: * written signed and dated informed consent obtained. * male or female patients aged ≥ 18 years. * a positive reversibility test * patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month) * using inhaled corticosteroids (ics) in monotherapy or using ics in a fixed or free combination with long acting beta2 agonists (laba) at a constant dose for two months before screening visit * not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to gina guidelines 2007) in the last month before screening visit * forced expiratory volume in the first second (fev1) ≥ 60% of predicted for the patient normal value. * non smokers or ex-smokers exclusion criteria: * pregnant or nursing (lactating) women. women of child-bearing potential unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum fsh levels \>40 miu/ml or are using one or more of acceptable methods of contraception * body mass index (bmi) \> 34 kg/m2. * patient with lower respiratory tract infections affecting the patient's asthma within 30 days of the screening visit. * use of systemic steroids in the last month. * patients with other lung diseases such as copd, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder. * patients who have an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease. * clinically relevant laboratory abnormalities * patients who have an abnormal qtcf interval value * intolerance or contra-indication to treatment with beta2-agonists and/or ics or allergy to any component of the study treatments. * patients treated with slow-release corticosteroids in the 3 months prior to screening visit. * patients being treated with anti-ige antibodies. * patients treated with laba or ics/laba fixed combination in the 24h before screening visit * severe asthma exacerbation in the last month before screening visit

Keywords: maintenance and reliever treatments