Kornimate/medical-research-clean huggingface dataset:
picc asymptomatic thrombosis study: a pilot study

Conditions: Peripheral ICC

Summary: the study purpose is to perform a preliminary, comparative evaluation of the hydrophilic biomaterial technology to confirm the performance of the catheter, by using ultrasound technology in-vivo.

this study will compare two different materials to evaluate asymptomatic thrombosis using ultrasound technology.

Eligibility criteria:
inclusion criteria: 1. patient is indicated for a medically necessary picc for therapeutic delivery medication 2. patient is eligible to receive a single lumen picc 3. patient is an adult who is prescribed a picc line 4. patient's expected duration of treatment requiring a picc for a minimum of 16 days post device implantation 5. patient understands and is willing to comply with all study requirements and has voluntarily signed the informed consent form (icf). exclusion criteria: 1. is pregnant, lactating, or is planning to become pregnant during the time of the study 2. has been previously enrolled in this post market clinical evaluation, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation 3. venous thrombosis in any portion of the vein to be catheterized 4. conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy 5. orthopedic or neurological conditions affecting the extremity 6. anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers, within a month of patient enrollment start 7. patients who are on anticoagulation therapy prior to the study (10-14 days). note: (if patients are placed on anticoagulation (low dose) therapy while hospitalized, these patients are allowed.) 8. patient has relinquished control of care to a guardian and/or facility 9. patient has any significant medical or physical condition that, in the opinion of the pi, would make the subject unsuitable for participation in the post market clinical evaluation 10. inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
a study of bms-986442 with nivolumab with or without chemotherapy in solid tumors and non-small cell lung cancer

Conditions: Advanced Solid Tumors; Non-small Cell Lung Cancer

Summary: the purpose of this study is to evaluate bms-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.


Eligibility criteria:
inclusion criteria: * participants in all parts of the study must have measurable disease per response evaluation criteria in solid tumors (recist) v1.1. * participants must have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * participants must have a life expectancy of at least 3 months at the time of first dose. exclusion criteria: * untreated symptomatic central nervous system metastases or leptomeningeal metastases. * concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study part b1 or treatment assignment in all other study parts. * participants with an active, known, or suspected autoimmune disease. other protocol-defined inclusion/exclusion criteria apply.

Keywords: bms-986442 nivolumab chemotherapy
crosscultural adaptation and validation of the italian version of the new knee society knee scoring system

Conditions: Knee Osteoarthritis

Summary: the present study aims to be a multicenter prospective analysis aimed at validating the italian version of the new kss introduced in 2011 15. to do this it is first necessary to create the translation of the questionnaire. several steps will be performed to obtain an adequate italian version of the new kss: 1. the english version of the kss will be translated into italian by 3 bilingual translators 2. the 2 versions will be submitted to the study collaborators (one per centre), the final version (accepted by all the study collaborators) will be translated back into english by 2 bilingual translators (native english) not aware of the initial version. the back translation will then be sent to the original author (prof. scott) to ensure that the consistency of the questionnaire has been maintained throughout all processes despite the necessary cultural adaptations. 3. once the definitive version has been obtained, it will be tested by 300 italian patients (with an estimated dropout of 20%) suffering from gonarthrosis. the patients will be distributed as follows: approximately 50 patients in each of the 6 centers (total 300). the number of patients was chosen considering approximately 17-18 patients for each of the 17 items, this choice is consistent with previously published studies on translation into other languages


Eligibility criteria:
inclusion criteria: * diagnosis of gonarthrosis and indication for primary tka surgery * age between 18 and 85 years * ability to respond to the proposed questionnaires and provide informed consent * availability for follow-up for one year after surgery exclusion criteria: * concomitant hip or spinal problems, understood as a cause of patient discomfort even if not yet undergoing medical or rehabilitation therapy * history of ipsilateral or contralateral knee surgery * congenital knee deformities * previous septic arthritis * neuromuscular pathology (e.g. polio) * simultaneous bilateral prosthesis or within 12 months of both knee, hip and ankle

Keywords: kss
different volatile anaesthetics and the depth of long term icu sedation

Conditions: Intensive Care Unit Syndrome

Summary: the mirus system (tim, andernach, germany) as well as the anaconda uses a reflector to conserve volatile anaesthetics (va). both systems can be paired with icu ventilators, but mirus features an automated control of end-tidal va concentrations (etva). we compare depth of 0.5 mac inhalational long-term sedation with isoflurane (iso), sevoflurane (sevo) or desflurane (des).

the study was approved by the appropriate institutional review board. thirty asa ii-iv patients, undergoing elective or emergency surgery under general anaesthesia were included and randomized into three equal groups: iso, sevo or des. we used mirus, a gas delivery system with a va reflector, just like anaconda, that can be paired with common icu ventilators. additionally, mirus features the unique ability to maintain the end-tidal concentration (etva) in target by automatically adjusting the delivery rate. every 8 hours, the rass was assessed by the nurse. the log of the eeg-narcotrend index (ni) was also included in the study.

Eligibility criteria:
inclusion criteria: * signing of the informed consent document (patient or relatives). * patient age 18 years or older. * asa i-iii exclusion criteria: * asa iv patients * epidural or spinal analgesia * allergy or known hypersensitivity to any of the study drugs * patients with known or suspected genetic susceptibility to malignant hyperthermia * previous participation in this trial * participation in another clinical trial within 4 weeks prior to selection. * pregnant women

Keywords: inhalational sedation
ultrasound study of entheses and small joints of hands and feet in patients with atypical form of psoriasis

Conditions: Ultrasound in Patients With Atypical Shape of Psoriasis

Summary: systematic study of the ultrasound infringements of tendons chest expanders of entheses the most involved in spondylarthropathies and small joints of hands and feet in expanding patients of psoriasis to estimate if there is an infra-clinical infringement of the psoriasic rheumatism .


Eligibility criteria:
inclusion criteria: * patients over 18 years * atypical psoriasis of the scalp and / or nails and / or psoriasis of folds * patient agreeing to participate in the study exclusion criteria: * psoriatic arthritis * rheumatic pain * arthritis * joint trauma in hands, elbows knees, feet * current treatment with methotrexate, soriatane, cyclosporine, corticosteroids * current treatment with biological therapy (anti-tnf, anti il 12-23) * previous history of rheumatic disease: inflammatory, microcrystalline, osteoarthritis * patients in physical or mental incapacity to agree
the timing of prophylactic antibiotics in cesarean section and the risk of post-operative febrile morbidity

Conditions: Cesarean Section

Summary: the purpose of this study is to determine whether the timing of prophylactic antibiotic administration for cesarean section (immediate preoperative versus intraoperative administration) impacts the rate of postoperative febrile morbidity. the specific aim of the project is to test the hypothesis that preoperative antibiotic administration will decrease the rate of composite postoperative febrile morbidity.


Eligibility criteria:
inclusion criteria: * gestational age \> 36 weeks * ability to understand requirements of the study * elective/non-emergent cesarean section selected as route of delivery by treating physicians exclusion criteria: * known fetal anomaly * exposure to antibiotics within 7 days of admission, including intrapartum group b streptococcal (gbs) prophylaxis * emergent cesarean delivery (i.e. for fetal distress, maternal distress, obstetric hemorrhage) * overt maternal intrapartum infection requiring antibiotics * prolonged rupture of membranes (\>18 hours)
haploidentical stem cell transplant with or without nk cell infusion in aml and mds

Conditions: Acute Myeloid Leukemia; Myelodysplasia

Summary: relapse after an allogeneic hematopoietic stem cell transplantation (hsct) is high in patients with advanced aml, in the 50% range. nk cells have been shown to possess significant anti-leukemic activity and may be used to reduce the incidence of relapse in patients with advanced aml. investigators hypothesize that the administration of a purified boost of nk cells on day +7 post hsct, will reduce the incidence of relapse from the current 50% to 25%. in a phase iii multicenter clinical study, 116 patients will be randomized to receive or not a boost of donor nk cells on day +7 post-hsct. the first 10 patients in the experimental arm will be analyzed for toxicity. the stopping rule will be a transplant related mortality of more than 50% in the first 20 patients who received nk cells.


Eligibility criteria:
inclusion criteria: * diagnosis of aml or mds * patients not in remission at the time of transplant * age 18-75 * ecog performance status \<2 * availability of a family hla haploidentical donor, eligible to donate both marrow cells and unstimulated lymphocytes (1 apheresis procedure at day +7) . exclusion criteria: * positive serologic markers for human immunodeficiency virus (hiv) * acute hepatitis b virus (hbv) or acute hepatitis c virus (hcv) infection
atomoxetine and oxybutynin in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea (OSA)

Summary: obstructive sleep apnea (osa) is common and has major health implications but treatment options are limited. osa patients show a marked reduction in upper airway (ua) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of ua compared to normal subjects. until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. however, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. in this protocol the investigators will test the effect of atomoxetine (a norepinephrine reuptake inhibitor) and oxybutynin (an antimuscarinic drug) administered together on osa phenotype traits and osa severity during sleep.


Eligibility criteria:
inclusion criterion: - ahi \> 20 exclusion criteria: * any medical condition other than well controlled hypertension. * any medication known to influence breathing, sleep/arousal or muscle physiology. * claustrophobia. * inability to sleep supine. * allergy to lidocaine, oxymetazoline hcl, atomoxetine/oxybutynin. * individuals with underlying cardiac disease, such as arrhythmias. * individuals taking psychiatric medications, such as atomoxetine, or any of the studied medications for medical care. * history of seizures * for women: pregnancy. * history of panic disorder / hyperventilation syndrome / attention deficit-hyperactivity disorder (adhd) / autism
organ preservation: weekly carboplatin & taxol w/concurrent rt for locally advanced laryngeal & hypopharyngeal ca

Conditions: Laryngeal Neoplasms; Hypopharyngeal Neoplasms

Summary: organ preservation: weekly carboplatin \& taxol w/concurrent rt for locally advanced laryngeal \& hypopharyngeal ca


Eligibility criteria:
inclusion criteria: * patients with locally advanced laryngeal \& hypopharyngeal ca

Keywords: organ preservation carboplatin taxol rt laryngeal & hypopharyngeal ca locally advanced laryngeal & hypopharyngeal ca
effects of pulmonary rehabilitation on walking speed in patients with copd or ild patients

Conditions: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Summary: the aim of this study is to evaluate the effects of a three-week inpatient pulmonary rehabilitation (pr) program on the walking speed in patients with chronic obstructive (copd) or interstitial lung disease (ild).

at most german traffic light crossings, a walking speed of 1,2m/sec is required to cross the road in time. patients who are unable to cross the road at this speed, expose themselves to an increased level of stress and possibly the risk of accidents. thus, they are discouraged from participating in an active social life. an uk study (nolan et al., thorax 2018) showed that only 10.7% of the 926 patients with moderate copd attained a walking speed of 1.2m/sec. as pr plays a key role in the management of chronic lung diseases in order to improve patients´ exercise capacity, the aim of this study was to evaluate the pr effects on the walking speed in patients with copd or ild. the investigators hypothesize that pr improves the ability to cross the road in the appropriate time.

Eligibility criteria:
inclusion criteria: * participation in a pulmonary rehabilitation program (schön klinik bgl) * indication: copd or ild * copd; fev1 \<50% * ild: fvc \<70% * written informed consent exclusion criteria: * non compliance

Keywords: walking speed dyspnoe stress anxiety traffic light
natural history of spinal muscular atrophy type 1 in taiwan

Conditions: Natural History of Type 1 Spinal Muscular Atrophy (SMA)

Summary: spinal muscular atrophy (sma) is an autosomal recessive disorder characterized by degeneration of motor neurons in the spinal cord and caused by mutations of the survival motor neuron 1 (smn1) gene. the investigators will conduct a systematic review of the contents and activities collected via a comprehensive case report form. patients who fulfilled diagnostic criteria for sma type 1 will be reviewed retrospectively.

the primary objective of this study is to investigate the natural history of patients with spinal muscular atrophy (sma) type 1 in taiwan. this study will provide further insights into the clinical course and pathogenesis of sma. several analyses will be conducted regarding overall survival, respiratory support, feeding and nutritional support. the following outcome variables will be examined: correlation between sma genotype and phenotype, survival, age of onset, and age of confirmed diagnosis, proportion of patients using non-invasive and invasive respiratory support, time to first use of respiratory support, proportion of patients on permanent ventilation, and time to permanent ventilation, number and average duration of hospitalizations, proportion of patients with gastrostomy, number of non-serious and serious respiratory infections, trend of growth parameter (e.g., body weight).

Eligibility criteria:
inclusion criteria: * jan. 1979\~ 30 jun. 2014 diagnosed with spinal muscular atrophy (sma)type 1 * onset of paralytic floppy infant less than 6 months of age * generalized hypotonia and symmetric weakness, which weakness is more severe in proximal than distal part of extremities * weakness in the legs is greater than in the arms * tendon reflexes are absent * neurogenic changes in electromyogram and/or muscle pathology * smn1 gene deletion or mutation exclusion criteria: * non-5q sma (no deletion or mutation of smn1 gene) * sma type 2, type 3 or type 4 (onset of sma after 6 months of age)

Keywords: type 1 spinal muscular atrophy (sma)
the immune response to stroke

Conditions: Stroke, Acute; Dementia

Summary: some patients develop cognitive decline after a stroke, but we don't always understand the mechanisms. it has been proposed that a proportion of the patients develop an autoimmune immune response, and that this could potentially explain the cognitive decline in some of the patients. the current study aims to investigate this hypothesis in a subgroup of patients with stroke.


Eligibility criteria:
inclusion criteria: * stroke \< 72 h * age \> 18 years exclusion criteria: * brain hemorrhage verified by ct or mri scan * previous or present immunological disease or other serious comorbidity * ongoing immune respons after infection or vaccination \< 1 month * cognitive without ability to understand and/or give an informed consent to participate in the study
impact of corpus luteum presence or absence in the incidence of preeclampsia after frozen embryo transfer

Conditions: Pre-Eclampsia; Frozen Embryo Transfer

Summary: identifying modifiable factors that contribute to preeclampsia risk associated with assisted reproduction can improve maternal health. recent studies have shown an increased risk for hypertensive disorders of pregnancy after in vitro fertilization, particularly for pregnancies occurring during a hormone replacement therapy such a donor egg recipient and a frozen embryo transfer. this risk may be partly attributable to the degree by which the assisted reproductive treatment affects the maternal hormonal environment, when the corpus luteum is a major source of reproductive hormones. on the other hand, cryopreserved embryos are usually thawed and replaced in in a natural or hormonally manipulated cycle; on this point, frozen embryo transfer is associated with better perinatal outcome regarding preterm birth and low birth weight yet higher risk of large for gestational age and macrosomia compared to fresh transfer. the objective of our study is to investigate whether the absence of corpus luteum adversely affects pregnancy and to analyse if there are differences in the perinatal outcomes due to differences in the endometrial preparation protocol for a frozen embryo transfer.


Eligibility criteria:
inclusion criteria * all patients who, after ivf-pgt-a treatment with their own oocytes, present a euploid embryo for transfer. * transfer of a single euploid embryo exclusion criteria: * moderate or high smoking (\> 5 cigarettes/day) * bmi ≥30 kg/m2 * chronic hypertension * history of preeclampsia in previous pregnancies * history of delayed uterine growth and placental insufficiency in previous pregnancies * use of donor sperm * woman's age ≥44 years * women with menstrual cycles longer than 35 days

Keywords: pre-eclampsia corpus luteum frozen embryo transfer endometrial preparation
comparison of feeding strategies for hypoplastic left heart syndrome infants

Conditions: Hypoplastic Left Heart Syndrome; Growth Failure

Summary: the purpose of the study is to determine if a continuous feeding regimen as compared to an intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic left heart syndrome (hlhs) after stage 1 procedures.

in recent years, survival after neonatal cardiac surgery has improved significantly. as life span has improved in hlhs/single ventricle variants (svv) survivors, focus has shifted to the understanding and management of associated health problems. growth failure is a well-recognized major co-morbidity in these patients. infants with hlhs/svv demonstrate progressive growth failure after stage 1 procedures, which appears to stabilize only after stage 2 procedures. poor nutritional status increases risk for post-operative infections, extends hospital length-of-stay, and adversely affects neurodevelopmental outcomes. to date, evidence-based feeding strategies that support adequate weight gain and improve nutritional status have not been identified after stage 1 procedures. continuous enteral feeding regimens have resulted in improved growth in a diverse population of infants with congenital heart disease and have been shown to decrease energy expenditure in premature infants and adults. a randomized, controlled study of hlhs/svv infants who underwent stage 1 procedures at a single medical center was conducted with the primary objective of comparing weight gain at hospital discharge between infants receiving a continuous feeding regimen versus an intermittent feeding regimen. secondary objectives were to compare growth and markers of nutritional status at hospital discharge between the two groups. the investigators hypothesized that infants with hlhs/svv who receive a continuous enteral feeding regimen versus an intermittent feeding regimen will demonstrate improved weight gain, growth, and nutritional status after stage 1 procedures at hospital discharge.

Eligibility criteria:
inclusion criteria: - subjects with hlhs/svv who underwent stage 1 procedures (norwood or hybrid procedure) who were inborn or transferred into the neonatal intensive care unit at columbia university medical center exclusion criteria: - excluded subjects were those with associated major congenital malformations (e.g. congenital diaphragmatic hernia, gastroschisis) or chromosomal anomalies, and/or those who were small for gestational age at birth. - subjects in whom a nasogastric tube or gastrostomy tube was not required for feeding at the time of enrollment and/or who were transferred to outside institutions for recovery after surgery.
knee injections for obese patients with knee arthritis

Conditions: Osteoarthritis of Knee

Summary: the purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function.


Eligibility criteria:
inclusion criteria: • patients with bmi ≥30 kg/m2 and radiograph-proven knee osteoarthritis who are interested in receiving a steroid injection for knee arthritis. exclusion criteria: * bmi \< 30 kg/m2 * uncontrolled diabetics with a hemoglobin a1c \> 8% * no other treatment within the time frame of the study. * patients that are undergoing physical therapy at the time of the study.

Keywords: knee osteoarthritis corticosteroid injection obesity
does pupil size matters in refractive surgery?

Conditions: Myopia

Summary: to determine the influence of pupil size in refractive surgery. if any influence exist.


Eligibility criteria:
inclusion criteria: - above 18 years suffers from myopia exclusion criteria: - suffer from keratoconus younger than 18 years old had previous eye surgery.

Keywords: refractive surgery pupil pupil size
j-pouch vs side-to-end anastomosis after hand-assisted laparoscopic low anterior resection for rectal cancer

Conditions: Quality of Life; Fecal Incontinence; Postoperative Complications

Summary: current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection


Eligibility criteria:
inclusion criteria: * patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope exclusion criteria: * refusal of the patient to participate * pregnancy, * previous radiation therapy, * those have cancers other than adenocarcinoma, * those planned to have local excision or abdominoperineal resection