Kornimate/medical-research-clean huggingface dataset:
low-dose versus standard dose alteplase in acute ischemic stroke , 4 monthes prospective study

Conditions: Acute Stroke

Summary: cohort a randomized control trial of ateplase 0.6, 0.75 and 0.9 mg/kg in 78 patients cohort b single arm 0.9 mg/kg ateplase in 330 patients combined cohort a and b evaluate different of death, intra-cerebral hemorrhage, numberof patient with mrs 0-1 at discharge and 3 months follow up, and other important stroke outcomes

we conducted the prospective study to compare the low-dose and standard-dose rtpa and identify the important factors predicted stroke outcomes in acute stroke patient received intravenous rtpa. in cohort a, during 2011-2012, 78 patients were randomly assigned to received intravenous rtpa 0.6 mg/kg , 0.75 mg/kg, or 0.9 mg/kg (1:1:1). after interim analysis during 2012-2017, in cohort b, 330 patients were assigned to receive standard-dose rtpa 0.9 mg/kg. the good outcomes were defined as improvement of modified rankin scale (mrs) by final score 0-1 or improvement \> 4 points at discharge or 3 months follow up, absent of intracranial hemorrhage within 36 hours treatment, 90-day post-stroke survival , and short hospital length of stay.

Eligibility criteria:
inclusion criteria: 1. diagnosis of acute ischemic stroke 2. age 18 to 80 years 3. onset of stroke symptoms with in 4.5 hours before initiation of study-drug administration 4. stroke symptoms present for at least 30 minutes with no significant improvement before treatment exclusion criteria: 1. patients with intracranial hemorrhage 2. the symptoms of time onset was unknown 3. symptoms rapidly improving or only minor before start of infusion 4. seizure at the onset of stroke 5. stroke or serious head trauma within the previous 3 months 6. administration of heparin within the 48 hours preceding the onset of stroke, with an activate 7. partial-thromboplastin time at presentation exceeding the upper limit of the normal range 8. platelet count of less than 100,000 per cubic millimeter 9. systole pressure greater than 185 mm hg or diastole pressure greater than 110 mm hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits 10. blood glucose less than 50 mg per deciliter or greater than 400 mg per deciliter 11. symptoms suggestive of subarachnoid hemorrhage, even if ct scan was normal 12. oral anticoagulant treatment 13. major surgery or severe trauma within the previous 3 months 14. other major disorders associated with an increased risk of bleeding

Keywords: ateplase intravenous recombinant tissue plasminogen activator acute is hemic stroke low-dose ateplase rtpa modified rankin 's scale
influence of exercise on the mobility and balance of individuals with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: outcomes from the investigators' recent investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically improvements in the postural balance and walking speed of individuals with ms. this investigation will evaluate mobility and postural balance improvements in individuals with ms who participate in a therapeutic protocol consisting of activity based exercises, and in individuals with ms that participate in challenging physical therapy protocol.

background: outcomes from the investigators' recent exploratory investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically relevant improvements in the postural balance and walking speed of individuals with ms. objective: the investigators anticipated that the promising results were due to the novel challenging postural balance and mobility exercises. the purpose of this investigation was to test this notion by evaluating the mobility and postural balance improvements that could be achieved in a cohort of individuals with ms who participated in a therapeutic protocol that consisted of activity based exercises, and a cohort of individuals with ms that participated in the challenging physical therapy protocol.

Eligibility criteria:
inclusion criteria: * definitive diagnosis of multiple sclerosis * kurtzke expanded disability status of 3.0 - 6.5 * able to walk on a treadmill at a minimum of 0.5 miles per hour while holding onto handrails * cognitively and emotionally competent * a mini-mental state examination score \> 21 * composite score on the computerized sensory organization test of \< 70 exclusion criteria: * documented ms-related relapse in the previous 6 months * major ms-specific medication changes within the previous 3 months * presence of another major co-morbidity such as neurological disorders, uncontrolled pain, hypertension, and diabetes
effect of providing stratification of low risk penicillin allergies on penicillin allergy label removal in icu setting

Conditions: Penicillin Allergy

Summary: currently it is estimated that at least 25 million people in the united states are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. there is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. previous studies have utilized quasi-experimental designs. test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. the investigators objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a single arm intervention pilot trial in the icu setting, which will pave the way for a future stepped wedge randomized control trial (stepped wedge trial entered separately in clinical trials.gov as nct03702270)


Eligibility criteria:
inclusion criteria: * vumc patients age 18 or older with a penicillin allergy reported in their chart and are medically stable, currently admitted to icu. exclusion criteria: * patients with a penicillin allergy reported in their chart under icu care, but who are currently medically unstable.
pharmacokinetics and safety of oral posaconazole (mk-5592)tablets in chinese participants at high risk for invasive fungal infections (mk-5592-117)

Conditions: Fungal Infection

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety of oral posaconazole tablets in chinese participants at high risk for invasive fungal infections. neutropenic participants undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes will be enrolled in the study.


Eligibility criteria:
inclusion criteria: * chinese participant * female of reproductive potential with a serum hcg level consistent with a nongravid state and agree to use 2 acceptable methods of birth control throughout the study * body mass index (bmi) \>=15 and \<=30 kg/m\^2 * anticipated or documented prolonged neutropenia and likely to last for at least 7 days due to: a) standard intensive chemotherapy, anthracycline-based or other accepted regimen (excluding any investigational agent) for a new diagnosis of acute myelogenous leukemia (aml); b)chemotherapy for aml in first relapse; or c) therapy for myelodysplastic syndromes in transformation to aml or other diagnoses of secondary aml (therapy related, antecedent hematological disorders) or chronic myelogenous leukemia in blast crisis * free from any clinically significant disease other than the primary hematologic disease that would interfere with administration of study medication or study evaluations exclusion criteria: * pregnant, intends to become pregnant during the study, or has been nursing * mentally or legally incapacitated, has significant emotional problems, or has clinically significant psychiatric disorder over the last 5 years * received systemic antifungal therapy (oral, intravenous, or inhaled) within 30 days of study enrollment for reasons other than antifungal prophylaxis * known or suspected invasive or systemic fungal infection * taken posaconazole within 10 days prior to study enrollment * major surgery, donated or lost 1 unit of blood, or participated in another investigational study within 4 weeks prior to the study * type 1 hypersensitivity or idiosyncratic reactions to azole agents * significant multiple or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food * moderate or severe liver dysfunction * chronic active hepatitis, cirrhosis, hepatocellular carcinoma (hcc), or other hepatic disease caused by a virus * previous electrocardiogram with a prolonged qtc interval * prior enrollment in this study or other posaconazole studies within 90 days of study entry * eastern cooperative oncology group (ecog) performance status was \>2 prior to induction chemotherapy for the underlying disease * known or suspected gilbert's disease
a safety and efficacy study evaluating ctx130 in subjects with relapsed or refractory renal cell carcinoma (cobalt-rcc)

Conditions: Renal Cell Carcinoma

Summary: this is a single-arm, open-label, multicenter, phase 1 study evaluating the safety and efficacy of ctx130 in subjects with relapsed or refractory renal cell carcinoma.

the study may enroll approximately 107subjects in total.

Eligibility criteria:
abbreviated inclusion criteria: 1. age ≥18 years and body weight ≥42 kg. 2. unresectable or metastatic rcc that has exploited standard of care treatment. 3. karnofsky performance status (kps) ≥80%. 4. adequate renal, liver, cardiac, and pulmonary organ function. 5. female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after ctx130 infusion. abbreviated exclusion criteria: 1. prior treatment with any anti-cd70 targeting agents. 2. prior treatment with any car t cells or any other modified t or natural killer (nk) cells. 3. history of certain central nervous system (cns), cardiac or pulmonary conditions. 4. active hiv, hepatitis b virus or hepatitis c virus infection. 5. previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for \>12 months, or any other localized malignancy with low risk of developing into metastatic disease. 6. primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 7. prior solid organ transplantation or bone marrow transplant. 8. pregnant or breastfeeding females.

Keywords: car t allogeneic renal cell carcinoma renal cell carcinoma with clear cell differentiation crispr-cas9
intrabdominal pressure in small bowel obstruction as a possible predictor for the need of operation

Conditions: Small Bowel Obstruction

Summary: small bowel obstruction (sbo) is a common surgical diagnosis. most of sbo are related to post operative adhesions and most of them resolve without the need of surgical intervention. the most important thing dealing with sbo is to identify the more complex obstructions that need surgery. some clinical, physiological and radiological signs are recognized as markers of a more complex obstruction. the pathophysiology of bowel obstruction is explained as damage created by pressure on the abdominal wall causing ischemia. yet there are no studies, as far as we know, that measure intra-abdominal pressure in sbo patients and it relation to the severity of the obstruction. in this study we will measure the intra-abdominal pressure in sbo patients systematically and we will examine if more severe obstructions are accompanied by elevated intra-abdominal pressure.


Eligibility criteria:
inclusion criteria: * older than 18 , diagnosis of small bowel obstruction exclusion criteria: * younger then 18 , pregnant women, large bowel obstruction, incarcerated hernia, large ventral hernia
effect of malnutrition on the prognosis in hemodialysis patients

Conditions: Chronic Renal Failure; Hemodialysis; Malnutrition

Summary: the purpose of this study is to examined the effect of malnutrition and/or inflammation on atherosclerosis and prognosis in hemodialysis.

malnutrition is known to affect their prognosis in hemodialysis patients. furthermore, recent studies indicate that malnutrition is associated with inflammation and atherosclerosis in these patients. in this study we examine the effect of malnutrition and/or inflammation on atherosclerosis and 5-year survival rate in 600 hemodialysis patients.

Eligibility criteria:
inclusion criteria: * hemodialysis for at least 6 months exclusion criteria: * disabled patients
epidemiology of speed skating-related injuries

Conditions: Sports Injury

Summary: speed skating is a sport in which there´s a lack of epidemiological studies. in line with the well-established model of sports injury prevention research proffered by van mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden. through an online survey filled by semiprofessional athletes, it is posible to obtain all this important information. this way, it will be possible to fulfill a gap in the literature and take action in the near future in order to reduce the prevalence of injuries in this sport.

a retrospective study will be performed in speed skaters. 100 speed skaters will be recruited. data of all injury along a whole season will be collected. patients' information, including age, number of years playing, skill level and injured body part, will be analysed

Eligibility criteria:
inclusion criteria: * being a speed skater and having competed in the 2018 spanish national championship exclusion criteria: * being unable to understand the questionaire, do not accept on participating in the study.

Keywords: prevalence multidirectional sport injury prevention athletic injuries
predictors of the metabolic effect of sleep loss

Conditions: Apnea; Obstructive Sleep Apnea (OSA); Obesity

Summary: to test whether baseline levels of slow wave activity (swa) during sleep are lower in obese adults, and even lower in persons with sleep disordered breathing (sdb) compared to lean adults. to compare levels of swa in individuals in relation to their sleep time, blood pressure, heart rate, and markers of glucose metabolism.


Eligibility criteria:
inclusion criteria: * healthy, * normal sleepers, * lean, overweight, * obese, * pre menopausal exclusion criteria: * no shift workers or night-shift workers, * no mental health disorders, * no acute or chronic health conditions (stable, well controlled hypertension are accepted), * no hormonal treatments, * no substances that may interfere with sleep, * problems with sleep

Keywords: sleep, apnea, osa, obese, middle-aged
contezolid acefosamil versus linezolid for the treatment of acute bacterial skin and skin structure infection

Conditions: Skin Diseases, Bacterial; Gram-Positive Bacterial Infections

Summary: the purpose of this study is to determine whether contezolid acefosamil is as safe and effective as linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections


Eligibility criteria:
inclusion criteria: * patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (absssi) * diagnosed with cellulitis/erysipelas, major cutaneous abscess, or wound infections exclusion criteria: * uncomplicated skin infections * severe sepsis or septic shock * absssi solely due to gram-negative pathogens * prior systemic antibiotics within 96 hours of randomization

Keywords: absssi acute bacterial skin and skin structure infection
rrx-001 in combination with irinotecan in metastatic or advanced cancer (payload)

Conditions: Malignant Solid Tumor; Metastatic Cancer; Advanced Cancer

Summary: this is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical activity of rrx-001 administered in combination with irinotecan. rrx-001 is associated with resensitization to irinotecan in tumors that are previously refractory. this effect has been attributed to the ability of rrx-001 to restore the expression of aberrantly silenced genes, thus re-establishing pathway functions. however, resensitization may have more than one mechanism, among them pgp pump inhibition and vascular modulation, leading to improved penetration of standard chemotherapy.

this dose escalation study consists of 5 sequential dose cohorts each administered rrx-001 with irinotecan. after the first 3 subjects of each cohort complete cycle 1, the safety will be assessed before moving to the next dose level. subjects in the current cohort will continue treatment immediately following the completion of cycle 1, for as long as therapy is tolerated and the recist v.1.1 definition of progression is not met.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of an advanced, malignant, solid tumor(s) with all standard treatment options having been exhausted or declined. * eastern cooperative group (ecog) performance status is 0-2 at screening. * measurable disease per recist v1.1 by radiographic techniques * acceptable liver function, serum creatinine and hematological status * female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on study day 1 and continuing until at least four weeks after administration of the subject's final dose of rrx-001. * subjects with brain metastases are eligible exclusion criteria: * concurrent anticancer therapy; however, radiotherapy is allowed * any history of hypersensitivity to irinotecan * cholangitis that required treatment or intervention within 4 weeks of study enrollment * bilirubin \> 2.0 mg/dl * serious medical or psychiatric illness likely to interfere with participation in this clinical study * if female, subject is pregnant and/or breastfeeding. * ugt1a1\*28 homozygote or heterozygote * bmi \>35
the statins on glucose homeostasis in subjects with impaired fasting glucose

Conditions: Diabetes

Summary: evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired fasting glucose.

statin therapy effectively reduces cardiovascular events. however, trial data1 and meta-analyses suggest that statins also confer increased risk of development of diabetes. in order to elucidate whether statins increase risk of diabetes, investigators conducted this study to evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired fasting glucose.

Eligibility criteria:
inclusion criteria: 1. age 35-70 years old 2. fasting blood glucose 100-125 mg/dl exclusion criteria: 1. a1c \>7.0% 2. 2hr glucose during ogtt \>200 mg/dl 3. total cholesterol \>280 mg/dl 4. previous diabetic history, coronary artery disease 5. allergy to rosuvastatin or parvastatin 6. baseline alt more than 3 times unl 7. serum cr \> 2.0 mg/dl 8. pregnancy, breast feeding or plan to be pregnant woman.

Keywords: statins glucose homeostasis diabetes impaired fasting glucose
strategy to prevent transmission of multidrug-resistant gram-negative organisms in icu

Conditions: Antibiotic Resistant Infection

Summary: 1. objective of study the purpose of this study was to investigate whether the active surveillance and preemptive isolation of multidrug-resistant gram-negative bacteria in the intensive care unit affected the reduction of the rate of acquisition of multidrug- resistant gram-negative bacteria (mdrgnb). 2. background treatment option for mdrgnb (carbapenem-resistant p. aeruginosa, carbapenem-resistant a. baumannii, carbapenem-resistant enterobacteriaceae) is limited. development of infection due to mdrgnb is common in icu. strategy to prevent transmission of mdrgnb is needed, and there is two approaches; first, antimicrobial stewardship program, and second, infection control strategy.the investigators aimed to figure out the role of active surveillance test and preemptive isolation of mdrgnb in reduction of acquisition rate of mdrgnb. 3. methods pragmatic cluster randomized, crossover, controlled trial during first period (6 months), intervention group (randomized 3 icus) perform daily chlorhexidine bathing, active surveillance test and preemptive isolation and contact precaution. control group (randomized 3 icus) perform standard precaution with daily chlorhexidine bathing, and start contact precaution when clinical isolates reveals mdrgnb. after 1 month washout period, intervention group and control group cross over for next 6 months.


Eligibility criteria:
inclusion criteria: * enroll all patients who admit to the icus during the study period exclusion criteria: * patients who discharge within 2 days after admission to icus
premature ovarian failure (genetic and physiopathologic analysis)

Conditions: Premature Ovarian Failure

Summary: premature ovarian failure (pof), syndrome observed in young woman, present consequences on hormonal and leads at definitive infertility. it's a rare and complex syndrome and for this reason, we propose to initiate a collaborative team network to understand better his genetic and physiopathology. we are going to realize a global study of this syndrome with clinical and fundamentals approaches. we wish that this project allows us to understand better the physiopathology of this rare disease. finally, pof responsible genes identification is the base for future development of therapeutics approaches.

premature ovarian failure (pof) is a rare but not exceptional disease concerning 0.1% of the more-than-thirty-years-old women. on the clinical aspect, patients present a primary or secondary amenorrhea depending on when the disease occurs in their lives. infertility is most of the time definitive and the yet only available therapy is auto implantation of cryopreserved oocytes. initiation of a substitutive hormonal treatment is also necessary to prevent the consequences of estrogenic hardship (i.e leading to osteoporosis). pof has numerous possible origins, and can be linked to auto-immune diseases, metabolic disorders (i.e. galactosemia) or even genetic abnormalities. according to her origin, pof is characterized by (a) a depletion of primary follicles, (b) increased or accelerated follicle atresia (c) an alteration of the recruitment of dominant follicle and (d) stopped follicular maturation. the purpose of our work is to organize a clinical and fundamental research network focussed on premature ovarian failure (pof). it will aim to collect clinical, biological, radiological and histological information on patients, and according to their phenotypes, to decide for searching possible genetic abnormalities leading to pof. and in the same time, the constitution of a broad tissue collection allows the study of ovarian transcripts, using pof as a pathologic model to describe ovaries and follicle development-involved genes.

Eligibility criteria:
inclusion criteria : experimental group: * 18 years \ 39 years * patient with amenorrhea since at least 3 months * patient with at least 1 fsh dosage \> 30 mui/l * patients between 40 and 45 years old with hormonal results indicating a pof declared before 39 years old will be included. * informed consent form signature control group: * 18 years \ 39 years * patient having a benign ovarian pathology justifying an ovarian surgery * informed consent form signature exclusion criteria: not applicable

Keywords: premature ovarian failure (pof) genetic analysis physiopathologic analysis