Kornimate/medical-research-clean huggingface dataset:
phase i/ii study of mitoxantrone, etoposide and gemtuzumab ozogamicin for acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to investigate the combination of gemtuzumab ozogamicin, mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.

the combination of mitoxantrone and etoposide is an active regimen in refractory/relapsed aml patients. in order to improve the efficacy of mitoxantrone and etoposide as second line therapy in patients with aml we proposed to conduct a phase i/ii clinical trial combining gemtuzumab ozogamicin with mitoxantrone and etoposide. the phase i portion of the trial will determine the maximum tolerated dose of gemtuzumab ozogamicin combined with mitoxantrone and etoposide and the phase ii portion of the trial will determine the efficacy and safety of the combined regimen in patients with aml.

Eligibility criteria:
inclusion criteria: * able to understand and have the ability to provide written consent * between 18 and 70 years of age * patients with cd33 positive (determined as cd33 expression in ≥ 20% of leukemic blasts) de novo aml that did not respond to first line induction therapy * ecog performance status of 0-2 * patients must have the following laboratory values within 48 hours prior to beginning protocol treatment: serum creatinine ≤ 1.5 mg/ml and calculated creatinine clearance ≥ 50ml/min (using the cockcroft-gault equation); ast ≤ 59 iu/l; alt ≤ 72 iu/l; total bilirubin ≤ 1.3 mg/ml; note: hematologic abnormalities will not be used as a criteria for entry or exclusion. * patients must have left ventricular ejection fraction (lvef) ≥50% * females of child-bearing potential must have a negative pregnancy test during screening and all subjects must agree to use an effective method of contraception. exclusion criteria: * patients with acute promyelocytic leukemia * prior use of mitoxantrone or etoposide or gemtuzumab ozogamicin * antecedent hematologic disorder preceding initial presentation of aml or therapy related aml * history of thromboembolic event within the past 12 months * hepatitis b or c or hiv positive serology * symptomatic central nervous system (cns) involvement * history of congestive heart failure * myocardial infarction in the past 6 months * uncontrolled, life-threatening infection that is not responding to antimicrobial therapy * history of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent * patient may not be receiving any other anti neoplastic investigational agents * inr\> 1.5 or patient is receiving systemic anticoagulation (e.g warfarin) * patient undergone autologous or allogeneic stem cell transplantation * other active malignancies except for non-melanoma skin cancer or cervical intraepithelial neoplasia * women who are pregnant or breastfeeding.

Keywords: acute myeloid leukemia refractory relapsed second line gemtuzumab ozogamicin mitoxantrone etoposide phase i phase ii
scrambler therapy in treating chronic pain in patients with rash from varicella zoster virus infection

Conditions: Dermatologic Complications; Pain; Viral Infection

Summary: this pilot clinical trial studies how well scrambler therapy works treating chronic pain in patients with rash from varicella zoster virus infection. scrambler therapy may help relieve pain from a rash caused by varicella zoster virus infection

primary objectives: i. to explore whether we can decrease post-herpetic neuralgia (phn) pain with scrambler therapy. outline: patients undergo scrambler therapy for approximately 30 minutes. treatment continues for 10 days in the absence of pain progression or unacceptable toxicity. after the completion of study treatment, patients are followed up for 10 weeks.

Eligibility criteria:
inclusion criteria: * pain of \>= 1 month (30 days) duration attributed to zoster, for which the patient wants intervention * pain at least a four out of ten problem during the prior week, on a 0-10 scale where zero was no problem and ten was the worst possible problem * eastern cooperative oncology group (ecog) performance status (ps) = 0, 1, or 2 * life expectancy \>= 3 months (90 days) * ability to complete questionnaire(s) by themselves or with assistance * provide informed written consent exclusion criteria: * any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown * pregnant women * patients with implantable drug delivery systems, e.g. medtronic synchromed * patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices) * patients with a history of myocardial infarction or ischemic heart disease within the past six months * patients with history of epilepsy, brain damage, use of anti-convulsants for seizure prevention, symptomatic brain metastases; note: anti-convulsant use is allowed for neuropathy and heart failure (hf) if on a stable dose * other identified causes of pain in the area that was affected by herpes zoster * skin conditions such as open sores that would prevent proper application of the electrodes * other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study * prior treatment with calmare mc-5a therapy * patient initiation of a new analgesic treatment within 7 days prior to initiation of protocol treatment
nutritional support in femur fracture rehabilitation

Conditions: Femur Fracture

Summary: this randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.

muscle-target nutritional supplementation has been domonstrated to enhance the recovery of muscle mass and increase the efficacy of a rehabilitation program in patients suffering from sarcopenia. femure fracture is responsible for increased immobilization resulting in loss of muscle mass which may be further emphasized by surgical stress. this randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.

Eligibility criteria:
inclusion criteria: * age 60 years or older * admission for physical rehabilitation after surgery for femur fracture * informed consent exclusion criteria: * any malignant disease during the last five years * known kidney failure (previous glomerular filtration rate \<30 ml/min); * known liver failure (child b or c) * psychiatric disease * severe cognitive impairment (mini mental state examination \<18) * endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis) * indications related to the study product: 1. more than 10 µg (400 iu) of daily vitamin d intake from medical sources 2. more than 500 mg of daily calcium intake from medical sources. 3. adherence to a high-energy or high-protein diet (up to three months before starting the study) 4. hypersensitivity to any component of the investigational nutritional supplement (including cow milk protein allergy to milk and lactose intolerance) * indication to or ongoing artificial nutrition support * inclusion in other nutrition intervention trials * investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements * refusal
transcranial direct current stimulation (tdcs)-enhanced stroke recovery

Conditions: Ischemic Stroke

Summary: the purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tdcs) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.


Eligibility criteria:
inclusion criteria: * ischemic stroke causing arm weakness within 5-15 days * no other neurological or psychiatric disease, who are able to perform study tasks exclusion criteria: * patients younger than 18 or older than 80 years * patients with more than one disabling stroke * patients with bilateral motor impairment * patients with poor motivational capacity, history of severe alcohol or drug abuse * patients with severe language disturbances, particularly of receptive nature * patients with serious cognitive deficits (defined as equivalent to a mms score of 23 or less) * patients with severe uncontrolled medical problems (e.g., seizures, progressive stroke syndromes, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age or others), * patients with unstable thyroid disease * patients with increased intracranial pressure * patients with unstable cardiac arrhythmia * patients with contraindication to tms or tdcs stimulation (pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull, patients who had a craniotomy, skin lesions at the site of stimulation) * patients who are not available for follow-up at 3 and 12 months * pregnancy * patients with contraindication to mri will not participate in mri

Keywords: tdcs stroke functional mri tms
post-stroke delirium in ischemic stroke patients

Conditions: Ischemic Stroke

Summary: this study is to investigate the predictors of post-stroke delirium, develop and validate a nomogram of post-stroke delirium in the ischemic stroke patients.

introduction: post-stroke delirium (psd) is associated with unfavorable prognosis. effectively identifying risk factors of psd and predicting psd is of essential. methods: this is a prospective, single-centered, cohort study.

Eligibility criteria:
inclusion criteria: 1. aged ≥18 years old;(2) ischemic stroke, confirmed by computed tomography (ct) or magnetic resonance imaging (mri) scans;(3) patients or their agencies agree to participate in this study. exclusion criteria: 1. brain dysfunction caused by non-vascular causes such as traumatic brain injury, brain tumor or metastatic brain tumor;(2) history of serious mental illness such as schizophrenia;(3) unable to cooperate to the assessment as deafness, blindness, aphasia, dysarthria;(4) be in coma \[glasgow coma scale (gcs)≤8 points\] or sedation \[richmond agitation sedation scale (rass)\<-3 points\], and do not ameliorate during study;(5) with incomplete data.
the predictive value of coexisting tmprss2-erg gene fusion and pten deletion in prostate cancer patients with biochemical failure status post salvage or radical radiation therapy

Conditions: Prostate Cancer

Summary: the objective of the study is to evaluate the predictive value of tmprss2-erg gene fusion and pten in patients with high risk prostate cancer treated with first line lhrh agonist after biochemical failure.

the objective of the study is to evaluate the predictive value of tmprss2-erg gene fusion and pten in patients with high risk prostate cancer treated with first line lhrh agonist after biochemical failure. patients in this study will be treated with standard hormonal treatment. patients will remain on treatment regardless of rising psa. psa, other systemic therapy maybe added and the patients with oligometastasis could be treated with radiation therapy; this would be at the discretion of the treating oncologist. the primary endpoint of this study is to determine the predictive value of tmprss2-erg gene fusion and pten in hormonal refractory free survival and clinical progression rate in three years. the secondary endpoints are to evaluate the relation between gleason score and tmprss2-erg gene fusion and pten independently and together, the relation between t stage and tmprss2-erg gene fusion and pten independently and together, and to determine the association of these markers with overall survival.

Eligibility criteria:
inclusion criteria: * t3a + * psa \> 20 * gleason 8 or higher * karnofsky performance status ≥ 70. * signed study-specific informed consent exclusion criteria: -
crossover comparison of two gadolinium contrast agents for use with mra of carotid, renal and peripheral arteries

Conditions: Carotid, Aortic, Renal or Peripheral Artery Disease

Summary: to compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced mr angiography of the carotid, renal/abdominal and peripheral arteries


Eligibility criteria:
inclusion criteria: * 18 yrs of age or older * referred for enhanced mra of carotid, renal/abdominal or peripheral arteries * able to provide written informed consent and comply with protocol requirements * highly suspected of or with known disease of the carotid, renal/abdominal or peripheral vasculature using specific criteria listed in the protocol exclusion criteria: * pregnant or lactating females * known allergy to one or more of the ingredients in the products under investigation * significant congestive heart failure ( class iv) * moderate to severe chronic kidney disease * therapeutic intervention of any kind for vascular disease in the territory of interest between the two contrast procedures * vascular stents in vessels of interest * received another contrast agent in the 24 hrs preceding or proceeding each exam * previously entered into the study * contraindications to mri * severe claustrophobia undergone dsa between the two exams
taf for hiv-hbv with renal dysfunction

Conditions: HIV and Hepatitis B Coinfection

Summary: the investigators aim at describing changes in renal glomerular and tubular function with after the switch from tdf to taf in hiv/hbv-coinfected patients with mild to moderate renal dysfunction and to assess the virological efficacy of taf on hbv infection. the study will include hiv/hbv-coinfected participants of the swiss hiv cohort study (shcs) who are under active care and have been on a stable, tdf-containing art regimen for at least 6 months. only patients with an estimated glomerular filtration rate (gfr) between 30 ml/min and 90 ml/min will be included. all individuals who agree to participate will be switched from a tdf-containing art regimen to a taf-containing triple art regimen at week 0 and will be followed for 48 weeks after the treatment change.

rationale: tenofovir alafenamide (taf) has been shown to cause less renal complications than tenofovir disoproxil fumarate (tdf) while having the same virological efficacy against hiv and hbv infections. in a recent study from the usa and japan, over 90% of hiv/hbv-coinfected individuals had a suppressed hbv viral load 48 weeks after tdf was replaced by taf. thus, taf might be a valuable treatment option for hiv/hbv-coinfected individuals with tdf-toxicity, especially in the context of resistance to lamivudine and entecavir. however, the safety and efficacy of taf has not been evaluated to date in hiv/hbv-coinfected patients with renal dysfunction. primary objectives: * to evaluate changes in glomerular and tubular renal function after switch from tdf to taf in hiv/hbv coinfected patients with renal dysfunction * to assess the hbv virological efficacy of taf in hiv/hbv coinfected patients with renal dysfunction switching from tdf to taf. secondary objectives: * to assess the percentage of and reasons for treatment interruptions * to describe toxicity events including liver-related complications * to evaluate changes in liver fibrosis intervention: in eligible patients willing to participate and who have signed an informed consent tdf will be replaced by taf on day 1 of the study. products: * tenofovir alafenamide/emtricitabine (taf/ftc) dose: one tbl. once per day in addition to at least one third compound or * elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (evg/cobi/ftc/taf) dose: one tbl. once per day study population: eligible patients from all 7 centers of the swiss hiv cohort study will be considered.

Eligibility criteria:
inclusion criteria: * hiv/hbv-coinfection * suppressed hiv-viremia (\<200 cp/ml) * on tdf-containing art since at least 6 months * egfr \> 30 ml/min and \<90 ml/min * written informed consent exclusion criteria: * study drug considered by the treating physician not a valid option for the patient * pregnancy * decompensated liver cirrhosis

Keywords: hiv hepatitis b renal dysfunction tenofovir alafenamide
the efficacy and safety of vitamin e mixed tocotrienols in patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: there is currently no effective treatment in als. oxidative stress, probably interacting with other neurodegenerative processes, is hypothesized to play a leading role in pathogenesis. these include mechanisms that promote glutamate excitotoxicity, mitochondrial dysfunction and axonal dysfunction. in a transgenic mouse model of fals that develops a disease with a clinical phenotype similar to als, dietary vitamin e supplementation delayed disease onset and slowed progression, although it did not prolong survival. when used as an experimental therapy in human trials, vitamin e did not affect survival significantly, but possibly slowed als progression. two large, prospective epidemiologic studies suggest that longterm use of vitamin e supplements could be inversely associated with risk of als or als death. in another study, higher baseline serum α-tocopherol was associated with lower subsequent risk of als. a modest, non-significant protective effect from supplementation was seen in subjects with baseline serum α-tocopherol levels below median levels. in the current study, we aim to investigate the effects of tocotrienols in patients with als, particularly in delaying disease progression as well as assessing its safety profile in this group of patients.


Eligibility criteria:
inclusion criteria: * patients who have a decrease of 1 to 4 points on the alsfrs-r score during the 12-weeks observation period prior to screening and enrollment * patients of less than 2 years after the diagnosis of als. * patients without respiratory symptoms (orthopnea, dyspnea) * capable of giving signed informed consent exclusion criteria: * patients who have developed respiratory failure necessitating ventilation * patients who have developed unsafe swallowing necessitating enteral feeding tube insertion * patients with other neurodegenerative disease such as parkinson's disease and significant mental health illness * patients with certain concomitant diseases which may affect the assessment of safety/efficacy i.e. malignancy within the last 5 years, congestive heart disease, liver disease, kidney failure, bleeding disorders and other autoimmune diseases etc. * pregnant, lactating, and probably pregnant patients. * patients taking vitamin e tocopherol or tocotrienols supplements within 1 month from screening and randomisation. * patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present. * women of child bearing potential or nursing mother, unless they are willing to practice effective contraceptive measures.

Keywords: als
epidemiologic patterns of bacteremia after trauma

Conditions: Bacteremia

Summary: presence of pelvic and liver injury on arrival in ed, gastrointestinal tract perforation and massive transfusion within the first 24 hours after trauma appear a significant risk factor for bacteremia. scoring with the iss, intra-abdominal and pelvic injury and presence of transfusion and shock at admission to ed appears a useful tool for identifying trauma patients at increased risk of bacteremia.

purpose: bacteremia is a major nosocomial infection problem in view of its high mortality. bacteremia occurs in trauma patients frequently and increases a morbidity and mortality. the aim of this study was to identify risk factors and to describe epidemiological patterns for early onset (eob) and late onset (lob) bacteremia after trauma. methods: all trauma patients admitted to surgical intensive care unit (sicu) and general ward (gw) from january 2011 to december 2015 were retrospectively enrolled. the following information was collected for each patient and recorded in a computer database: demography, severity of trauma according to the injury severity score (iss) and each abbreviated injury score (ais), severity of coma according to the glasgow coma scale (gcs), presence of shock and transfusion. early onset bacteremia was defined as eob when onset occurred within 7 days after trauma, and late onset bacteremia was defined as lob when appearing after 7 days from trauma.

Eligibility criteria:
inclusion criteria: * the patients who admitted to intensive care unit (icu) or general ward (gw) through the emergency department after trauma were studied exclusion criteria: * patients who arrived on dead-on arrival

Keywords: trauma clabsi
efficacy of exercise at a fitness club for cardiovascular risk reduction

Conditions: Diabetes Mellitus; Hypertension; Hyperlipidemia

Summary: the purpose of the study is to determine whether exercise has further beneficial effects on improving cardiovascular risk factors such as hypertension, high cholesterol level or diabetes mellitus, when added to the standard program of health check followed by life style recommendations.

multiple risk factors contribute to the causation of atherosclerotic cardiovascular disease. past studies indicate that exercise exerts its protective effects on the disease through actions on multiple cardiovascular risk factors simultaneously; however, the studies focused on the effect of exercise predominantly on subjects with a single risk factor. does exercise differentially act on various risk factors in the same subject? do subjects with multiple risk factors respond differently to exercise than those predominantly with a single risk factor do? to our knowledge, this is the first large-scale study to test the efficacy of exercise on subjects with multiple risk factors. exercise in fitness clubs has uniquely fitting features for middle to older aged people with multiple risk factors: access is relatively easy because there are usually many clubs throughout the city; the control of exercise intensity or heart rate is made precise, rendering exercise safer when treadmills or bicycles are used as a mainstay of aerobic exercise as in this study; and cardiac arrest, the most feared complication of exercise, will be most likely to be properly handled since in recent years the installment of automated external defibrillators has been increasingly popular in many clubs. comparison: exercise vs. standard care comparison is to be made only for the first 6-month period. the second 6-month period is for follow-up and other purposes.

Eligibility criteria:
inclusion criteria: body mass index (bmi) of 24.2-34.9 with 2 or more of the following risk factors: * resting systolic blood pressure of 130-179 mmhg * fasting blood glucose of 110-139 mg/dl, or hba1c ≥ 5.8 when casual blood sugar is 140-199 mg/dl * ldl-cholesterol of 120-219 mg/dl exclusion criteria: * diastolic blood pressure of 110 mmhg or greater * history of clinical heart disease or stroke * orthopedic problems that might interfere with exercise * dementia * abnormal exercise ekg test results * private physician's disapproval

Keywords: exercise fitness club randomized controlled trial cardiovascular risk factor overweight inactivity