Kornimate/medical-research-clean huggingface dataset:
the effect of tash in patients with hocm

Conditions: Hypertrophic Obstructive Cardiomyopathy

Summary: to examine patients with hypertrophic obstructive cardiomyopathy (hocm) before and after septal alcohol ablation, to investigate the effect of the treatment in regards to changes in myocardial function, perfusion, invasive hemodynamics and exercise tolerance.

patients with hocm who develop symptoms of heart failure are treated initially with non-vasodilating ß-blockers or verapamil to decrease myocardial contractility and heart rate. a substantial part of patients remain symptomatic despite medical treatment. in these patients interventional or surgical treatments (septal reduction therapies (srt)) to reduce left ventricular outflow tract obstruction (lvoto) is considered in the presence of moderate to-severe symptoms (new york heart association - functional class (nyha) iii-iv) and/or recurrent exertional syncope and an lvoto gradient ≥50 mm hg. in some centers, invasive therapy is also considered in patients with mild symptoms (nyha class ii) who have a resting or maximum provoked gradient of ≥50 mm hg (with exercise or valsalva's maneuver) and moderate-to-severe mitral valve regurgitation. advanced treatment options are alcohol septal ablation (asa) or surgical myectomy often combined with mitral valve reconstructive surgery. these treatments have similar outcomes in terms of gradient reduction, symptom improvement and exercise capacity no previous trials have examined the effect of asa in hocm with respect to changes in central hemodynamics and myocardial performance during exercise. 24 hocm patients will be examined prior to asa, and approximately six-nine months after asa. the examination set-up consists of simultaneous 1) transthoracic echocardiography (tte), 2) right heart catheterization (rhc) and 3) cardiopulmonary exercise test (cpx).

Eligibility criteria:
inclusion criteria: * left ventricular wall thickness ≥ 15 mm in one or more myocardial segments that is not explained by loading conditions * lvot gradients ≥ 30 mmhg at rest and/or ≥ 50 mmhg at valsalva's maneuver or exercise * nyha ≥ iii exclusion criteria: * \< 18 years * fertile women who do not use anti-contraceptives * pregnancy * patients are allowed to have a pacemaker (eg. an implantable cardioverter defibrillator (icd)) but cannot be pace-dependent * amiodarone treatment * persistent or permanent atrial fibrillation/flutter * previous srt * alcohol or drug abuse * significant co-morbidity (judged by the investigator) * patients who cannot give valid consent (e.g. mental illness or dementia) or who do not understand danish.
mandibular slotplates

Conditions: Craniofacial Abnormalities

Summary: a new osteosynthesis system for orthognathic surgery was proposed.this system allows small intra-operative adjustments of the bone fragments during the osteosynthesis phase of the operation (also known as the slot principle). another possible advantage are the slant screw holes with chamfered ridges allowing easy placements of the screws via the small incision wound without undercuts in between the plate and the screwheads.

initial slotplates were developed for le fort i osteotomies, zygoma 'sandwich 'osteotomies and genioplasties. those plates allowed for the slot principle to be performed during orthognathic surgery. mandibular slotplates for bilateral sagittal split osteotomy (bsso) were recently designed. the aim of the study is to evaluate their clinical usefulness and the applicability of the slot principle with these plates in bsso.

Eligibility criteria:
inclusion criteria: • patients undergoing single osteotomy bsso surgery exclusion criteria: • concomitant surgeries at the same time.

Keywords: orthognathic surgical procedures osteosynthesis
comparison of open and minimally invasive surgical techniques in the treatment of degenerative one-level stenosis of lumbar spine

Conditions: Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)

Summary: the purpose of this study is to evaluate the clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (plif) and a minimally invasive procedure (mis tlif). according to the hypothesis, we assume that unilateral approach of mis tlif allows for adequate bilateral decompression of one-level central stenosis of the lumbar spine. using mis tlif it is possible to perform reliable fixation of a spine segment and the formation of a complete intervertebral bone fusion. the long-term clinical results of surgical treatment with minimally invasive technologies (mis tlif) and traditional open approach (plif) suspected to be comparable.


Eligibility criteria:
inclusion criteria: * syndrome of mono- or polyradicular compression of the nerve roots with / without a reflex pain syndromes, caused by stenosis of one lumbar spine segment; * intermittent claudication caused by stenosis of one lumbar spine segment; * one-level spine stenosis in combination with local segment instability or degenerative spondylolisthesis at the same spine segment, requiring fusion in only one lumbar segment exclusion criteria: * bilateral foraminal lumbar spine stenosis; * lumbar spine stenosis more than one-level; * spondylolisthesis ii degree and more; * sagittal imbalance; * fusion the same lumbar spine segment after surgery previously; * other diseases of the spine, including trauma, tumor and inflammatory diseases of the lumbar spine, etc.

Keywords: intraoperative procedures
phase 1 study of pk and safety of tebipenem pivoxil hydrobromide (tbpm-pi-hbr) in subjects with various degrees of renal function

Conditions: Renal Impairment

Summary: evaluation of the pharmacokinetics (pk) of tbpm-pi-hbr in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (esrd) receiving hemodialysis (hd) therapy.


Eligibility criteria:
key inclusion criteria: * adult males or females, 18 years of age or older. * bmi ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg * medically healthy without clinically significant abnormalities (healthy volunteers) or medically stable without clinically significant acute or chronic illness (subjects with renal disease). * non-smoker for at least 1 month prior to screening for the study. * ability and willingness to abstain from alcohol, caffeine, xanthinecontaining beverages or food. key exclusion criteria: * any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. * electrocardiogram (ecg) with qtcf interval duration equal or greater than 500 msec * hemoglobin (hb), hematocrit (hct), white blood cell count (wbc), or platelet count less than the lower limit of normal range of the reference laboratory (cohort 1). hb \< 8.5 gm/dl, wbc ≤ 3,000 cells/μl or platelet count ≤ 100,000 cells/μl (cohorts 2-5). * results of biochemistry tests for alanine aminotransferase (alt), aspartate aminotransferase (ast) and bilirubin greater than 1.5 x the upper limit of normal (uln) for the reference laboratory. * recent history of known or suspected clostridium difficile infection. * history of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic academia). * history of chronic liver disease, cirrhosis, or biliary disease. * history of seizure disorder except childhood history of febrile seizures. * positive urine drug/alcohol testing. * positive testing for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c (hcv) antibodies. * history of substance abuse or alcohol abuse. * use of antacids within 24 hours prior to study drug administration. * known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication.

Keywords: end state renal disease (esrd) renal insufficiency renal impairment renal disease hemodialysis
delafloxacin iv and os administration compared to best available therapy in patients with surgical site infections

Conditions: Surgical Site Infection

Summary: the purpose of this study is to assess the efficacy and safety of delafloxacin administered as iv and oral formulation in comparison with best available therapy (bat) in patients with superficial or deep incisional surgical site infection following a cardiothoracic/related leg or abdominal surgery.

this is a randomized, observer-blinded, active-controlled, parallel-group, multicenter, phase iiib study for the treatment of incisional, superficial or deep, surgical site infection after cardiothoracic /related leg or abdominal surgery (i.e patients who are at risk of microbiologically resistant infections). iv to be switched to oral delafloxacin will be compared to treatments that represent the best available therapy (bat) for either cardiothoracic/related leg or abdominal surgical site infection (ssi). approximately 600 male and female eligible patients will be randomly assigned in a 1:1 ratio to receive delafloxacin or bat. for patients who are randomised to bat, the investigator will choose one out of two treatments available (two available for the cardiothoracic/related leg and two available for abdominal ssi) as most appropriate for patient characteristics and local epidemiological pattern. duration of study depends on treatment duration (range: minimum 5 to maximum 14 days, as per investigator's judgment) followed by visits up to 30 days after end of treatment. patients will be hospitalized from screening (within 30 days from surgery) and will remain hospitalized until considered improved or cure as per investigator's judgment.

Eligibility criteria:
inclusion criteria: * male or female patients aged more than 18 years. * patients with a history of cardiothoracic / related leg or abdominal surgery, occurred within 30 days and no implant is left in place, and a diagnosis of superficial or deep ssi according to the cdc definition. * the severity of infection requires an iv treatment and patient hospitalization according to the investigator's judgment. exclusion criteria: * previous iv antimicrobial therapy exceeding 24-hour duration during 72 hours prior to first dose. * any infection expected to require systemic antimicrobial agents other than study treatment(s). * medical history of significant hypersensitivity or allergic reaction or contraindication to the study drugs * medical history of central nervous system (cns) disorders * medical history of myasthenia gravis. * medical history of c. difficile diarrhea. * organ-space infection. * complicated intra-abdominal infection (ciai) * chronic or underlying conditions at site of infection that may complicate the assessment of clinical response or would interfere with ssi healing. * underlying disease leading to deep immunosuppressive status. * end-stage renal disease, crcl \<15 ml/min.

Keywords: infection, surgical infection
a long-term extension study for participants previously treated with eb-101 for the treatment of rdeb

Conditions: RDEB

Summary: a long-term extension study for participants previously treated with eb-101 for the treatment of recessive dystrophic epidermolysis bullosa (rdeb)

this is an open-label, long-term, follow-up study in participants from prior interventional trials involving surgical application of gene-corrected keratinocyte sheets (eb-101) for the treatment of rdeb wound sites. up to 22 participants will be enrolled in this study, with follow-up through at least 5 years post treatment. patient-reported outcomes and safety will be assessed throughout the study, and where applicable, compared to baseline of the preceding interventional eb-101 trial. upon completion, participants will transfer to an annual monitoring program for additional 10 years of phone visits.

Eligibility criteria:
inclusion criteria: * willing and able to give consent/assent; * if under the age of 18, guardian(s) is/are willing and able to give consent; * prior study treatment with eb-101. exclusion criteria: * inability to properly follow protocol as determined by the principal investigator
nasal intermittent positive pressure ventilation(nippv) vs continuous positive airway pressure for respiratory distress syndrome

Conditions: Nasal Intermittent Positive Pressure Ventilation; Nasal Continuous Positive Airway Pressure

Summary: in the past, several studies have compared the effects between nasal intermittent positive pressure ventilation(nippv) and nasal continuous positive airway pressure(ncpap) on the incidence of intubation in preterm infants, and the results were inconsistent.the purpose of the present study was to compare nippv with ncpap on the need for endotracheal ventilation and subsequent complications

to this day, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. nasal continuous positive airway pressure (ncpap) and nasal intermittent positive pressure ventilation (nippv) are two widely used ways of noninvasive ventilation strategies in preterm infant. as compared with invasive ventilation, ncpap reduces the risks abnormal neurodevelopment. however, there is only 60% success rate of avoiding intubation in the preterm neonate supported with ncpap. supplying with an intermittent peak pressure on ncpap, nippv is considered as a strengthened version of ncpap with increased flow delivery in the upper airway, increased minute volume and functional residual capacity and recruitment of collapsed alveoli, improved stability of the chest wall and reduced asynchrony of thoraco-abdominal movement,which have been proven to be crucial to decrease the incidences of invasive ventilation and death. however, studies have compared the effects between nasal intermittent positive pressure ventilation(nippv) and nasal continuous positive airway pressure(ncpap) on the incidence of intubation in preterm infants, and the results were inconsistent.

Eligibility criteria:
inclusion criteria: * gestational age (ga) is from 26 to 37 weeks; * diagnosis of rds. the diagnosis of respiratory distress syndrome(rds) will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest x-ray findings; * rds silverman score\>5; * informed parental consent has been obtained. exclusion criteria: * severe rds requiring early intubation according to the american academy of pediatrics guidelines for neonatal resuscitation; * major congenital malformations or complex congenital heart disease; * group b hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; * cardiopulmonary arrest needing prolonged resuscitation; * transferred out of the neonatal intensive care unit without treatment.
rfr change of precise segmental versus complete renal arterial clamping during lpn for clinical t1 rcc

Conditions: Renal Cell Carcinoma

Summary: renal functional reserve may be better in patients with clinical t1 renal cell carcinoma(rcc) undergoing laparoscopic partial nephrectomy with precise segmental renal artery clamping than those with complete renal arterial clamping.

renal functional reserve (rfr) describes the capacity of the intact nephron mass to increase glomerular filtration rate(gfr) from baseline in response to stimuli (e.g., protein load).we hypothesized that renal functional reserve may be better in patients with clinical t1 renal cell carcinoma(rcc) undergoing laparoscopic partial(lpn) nephrectomy with precise segmental renal artery clamping than those with complete renal arterial clamping.

Eligibility criteria:
inclusion criteria: * 1.age ≥18 2.estimated gfr \>30 ml/min/1.73m2 3.anticipated intraoperative warm ischemic time ≤30 min 4.subjects who signed informed consent forms exclusion criteria: 1. allergy to iothalamate, shellfish or iodine 2. use of metformin or amiodarone 3. intraoperative warm ischemic time \>30 min 4. inability to maintain a stable regimen of medications which affect gfr for \> one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers) 5. use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim) 6. acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy 7. inadequate intravenous access 8. severe anemia (hct \<21%) 9. acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dl on most recent labs prior to enrollment) 10. history of contrast-induced nephropathy 11. hyperthyroidism 12. pheochromocytoma 13. sickle cell disease 14. urinary retention or incontinence 15. status post organ transplant 16. pregnancy or active breast feeding 17. cognitive impairment with inability to give consent 18. institutionalized status

Keywords: laparoscopic partial nephrectomy precise segmental renal arterial clamping renal cell carcinoma renal functional reserve
adjuvant treatment of concurrent rt and capox or capecitabine alone for stage ii and iii rectal cancer

Conditions: Rectal Neoplasms

Summary: the purpose of this study is: * to compare the long-term of survival and local/regional control between the two postoperative concurrent chemoradiotherapy regimens: capecitabine vs. oxaliplatin and capecitabine,for stage ii and iii rectal cancer * to compare the toxicity profile between the two different concurrent chemoradiotherapy regimens.

adjuvant 5-fu based concurrent chemoradiotherapy and chemotherapy is the standard care for locally advanced stage ii-iii rectal cancer, based on several randomized phase iii clinical trials. with this standard treatment, 5-year local failure rate and distant metastasis rate is 10% and around 35%, respectively. capecitabine, an analog of 5-fluoruracil (5fu), was demonstrated to have similar treatment results compared to 5-fu, but have much lower toxicities. oxaliplatin based chemotherapy, also showed a better disease-free survival rate compared with 5-fu based-regimen. so far, some phase i/ii studies have shown the safety and preliminary results of either concurrent chemotherapy of capecitabine or oxaliplatin and capecitabine. the long-term results in comparison of capecitabine concurrent chemoradiotherapy with oxaliplatin/capecitabine concurrent chemoradiotherapy need to be further analyzed.

Eligibility criteria:
inclusion criteria: * 18-75 years old,male or female * r0 surgery * pathologically approved as stage ii or stage iii * enrolled within 6 months from the date of surgery * upper border of tumor before surgery was under l5 * kps\>70% or ecog 0-2 * no prior radiotherapy in the past 6 months * received chemotherapy no more than 4 cycles after surgery * hgb\>100 g/l, wbc≥3.5x109 /l, plt≥100x109 /l; cr\<1.5 x upper normality，tb\<2.5 x upper normality，ast or alt\<2.5 x upper normality，akp\<2.5 x upper normality * signed consent exclusion criteria: * other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer * pregnancy or in lactation * hgb\<100 g/l, wbc\<3.5x109 /l, plt\<100x109 /l; cr≥1.5 x upper normality，tb≥2.5 x upper normality，ast or alt≥2.5 x upper normality，akp≥2.5 x upper normality

Keywords: rectal cancer concurrent chemoradiotherapy adjuvant therapy phase iii study
phase angle and mortality in patients with cirrhosis

Conditions: Malnutrition

Summary: a few pha cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. however, pha needs specific validation in different ethnic groups. the aim of this study was to evaluate the pha cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.

malnutrition is a frequent complication of cirrhosis, and it has been associated with a more severe disease and decompensating events. despite its relevance, there is no gold standard for nutritional assessment in cirrhosis, and intrinsic pathophysiologic changes make biochemical markers and traditional methods used to evaluate malnutrition unreliable. phase angle (pha) obtained from bioelectrical impedance has been successfully used as a nutritional marker in several diseases such as chronic renal failure, cancer, and hiv, where it has been associated with prolonged in-hospital stay and mortality. in cirrhosis, research linking malnutrition to increased mortality has yielded conflicting results, likely due to the lack of a gold standard. a few pha cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. however, pha needs specific validation in different ethnic groups. the aim of this study was to evaluate the pha cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.

Eligibility criteria:
inclusion criteria: * 18-65 years old ambulatory patients diagnosis of liver cirrhosis exclusion criteria: * acute or chronic liver failure heart failure hepatocellular carcinoma pregnancy acute infections

Keywords: phase angle liver cirrhosis mortality malnutrition
association of lutein, zeaxanthin and brilliant blue in chromovitrectomy

Conditions: Epiretinal Membrane; Macular Hole; Proliferative Diabetic Retinopathy

Summary: the aim of this study is to test the efficacy of the combination of dye lutein, zeaxanthin and brilliant blue to stain the internal limiting membrane as well as the epiretinal membranes during the vitrectomy surgery.

twenty five patients with epiretinal membrane, macular hole or proliferative diabetic retinopathy and indication of vitrectomy surgery will be selected to participate in this study.

Eligibility criteria:
inclusion criteria: * patients over 18 years, both gender * diagnosis of epiretinal membrane or macular hole or proliferative diabetic retinopathy * indication of surgical treatment for removal of the epiretinal membrane exclusion criteria: * any history of eye disease * glaucoma * eye infection affecting any structure provided eye

Keywords: chromovitrectomy epiretinal membrane