Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of paclitaxel in correlation with adverse events in cancer patients with and without liver impairment

Conditions: Liver Diseases

Summary: the study aims to assess the pharmacokinetics of paclitaxel and its two major metabolites in patients with normal and impaired liver functions.

population pharmacokinetic study in patients with normal or impaired liver functions, receiving paclitaxel for cancer treatment. 40 patients with histologically confirmed solid tumors will be enrolled in the study: * 20 patients have normal liver functions as defined by transaminase \< 2.6 x uln and bilirubin values \< 1.26 x uln. * 20 patients with liver impairment as defined by transaminase 2.6 - 10 x uln and bilirubin values 1.26 - 5 x uln.

Eligibility criteria:
inclusion criteria: * patients with histologically proven non haematopoietic malignancy (ovarian, breast and lung cancer). * age between 18 and 70 years * at least a 4-week interval between the last dose of previous chemotherapy protocol and registration (6 weeks in case of treatment with carboplatin). * glomerular filtration rate \> 60 ml/min * an eastern cooperative oncology group performance status 0-2, a life expectancy of \> 12 weeks, adequate bone marrow function \[absolute neutrophil count (anc) ≥ 1 x 109 and platelets ≥ 100 x 109\] * patient accessible for treatment and follow-up and written informed consent. exclusion criteria: * prior treatment with paclitaxel or other taxanes. * pre-existing motor or sensory neurotoxicity \> grade 2 according to world health organization (who) criteria. * active infection or other serious underlying medical condition (including prior allergic reactions to paclitaxel or the drug's constituents), dementia or significantly altered mental status, symptomatic brain or liver metastases, history of atrial or ventricular arrhythmias or congestive heart failure even if medically controlled, history of clinical and electrocardiographically documented myocardial infarction. * simultaneous use of any medication, dietary supplements, or other compounds known to inhibit affect the pharmacokinetics of paclitaxel. * patients with difficult blood sampling.

Keywords: paclitaxel pharmacokinetics egypt
therapeutic benefit of preoperative supplemental vitamin d in patients undergoing brain tumor surgery

Conditions: Brain Neoplasms

Summary: vitamin d supplementation not only has beneficial effects on morbidity and mortality in critically ill patients but it may also lead to alleviate of seizure, brain edema, infection, pain and some other perioperative complications, possibly in part through an attenuation of the immune response.in this trial patients with brain tumor under craniotomy will receive a single high dose vitamin d compared to control group.

a randomized, double blind, controlled trial will be conducted in neurosurgery ward, operating room (or) and intensive care unit (icu) in tehran, iran. after a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. the participants are 60 eligible hospitalized patients that diagnosed with brain tumor and need to craniotomy, aged ≥ 18 years. intervention patients will be received an intramuscular (im) single dose of vitamin d (300000 iu). patients will be evaluated for occurrence of perioperative complications and clinical outcomes immediately after surgery until 1 month later and 1 and 6 months mortality.

Eligibility criteria:
inclusion criteria: * written informed consent of patient or legal representative * 25(oh)d level below 20ng/dl exclusion criteria: * other trial participation, including previous participation in the pilot trial * pregnant or lactating women * hypercalcemia * hyperphosphatemia * tuberculosis * sarcoidosis * history of nephrolithiasis * history of hyperparathyroidis * medications that interfere with vitamin d metabolism * renal insufficiency

Keywords: vitamin d brain neoplasms perioperative complications clinical outcomes craniotomy immune system
cholinergic deep brain stimulation for alzheimer's disease

Conditions: Alzheimer Disease, Early Onset; Dementia; Alzheimer Disease

Summary: this project will investigate the potential of deep brain stimulation to improve cognitive abilities and counteract the effects of alzheimer's disease. deep brain stimulation electrodes targeting the nucleus basalis of meynert (nb) will be implanted bilaterally in a cohort of patients. nb is the sole source of acetylcholine to the neocortex. such stimulation may not only treat the cognitive symptoms but may have disease-modifying effects. drawing from animal experiments in non-human primates that showed success of this approach, intermittent stimulation will be delivered at 60 pulses per second for 20 seconds of each minute for one hour per day. the study team will recruit patients, shortly after first being diagnosed with alzheimer's disease. the study design will test the safety and efficacy of stimulation, potential benefits in cognitive function assessed with a battery of neurocognitive tests, cholinergic neurotransmission evaluated with positron emission tomography, and ability to reverse alzheimer's biomarkers, including beta amyloid and tau in the cerebrospinal fluid. successful completion of this project will lead to a potential new intervention for the cognitive impairments of alzheimer's disease.


Eligibility criteria:
inclusion criteria: * probable, early-stage ad, as defined by nia-aa 2018 criteria, including amnestic mild cognitive impairment (mci) * clinical dementia rating (cdr) global score of 0.5-1.0 with a memory box score of at least 0.5 * mmse ³ 23 * stable cognitive enhancer medication equivalent to 10 mg/day donepezil or less for at least 60 days * stable other medications (e.g., psychotropics) * valid informed consent if female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study * an available caregiver willing to participate * subject is living at home and likely to remain at home for the study duration. exclusion criteria: * active or unstable psychiatric illness * inability to tolerate general anesthesia. * another concurrent cns condition or clinical co-morbidity interfering with the study (ie, stroke, parkinson's disease, lewy-body dementia or other form of dementia, other evidence of significant structural brain pathology). * current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit * verbal iq\<85 * contraindication regarding anesthesia, stereotactic operation, mri (e.g. claustrophobia, or implants), or pet (e.g. insulin dependent diabetes) procedures * inability to undergo pet or mri imaging * active alcohol or substance abuse as defined by dsm5 * is unable or unwilling to comply with protocol follow-up requirements * is actively enrolled in another concurrent clinical trial. * terminal illness associated with expected survival of \<12 months

Keywords: stimulation nucleus basalis alzheimer memory
fresh-teen: families responsibility education support health for teens

Conditions: Overweight and Obesity

Summary: the objective of this proposed study is to collect initial efficacy data on a behavioral weight loss (bwl) program for teens, which also includes emotion regulation strategies (er), to standard bwl.

the study will compare the efficacy of bwl + er and bwl. investigators will provide 6 months of treatment (bwl + er or bwl) and will follow participants at 12-months post-treatment (total time = 18 months). investigators will recruit adolescents with overweight and obesity and their parents. dyads will be assessed at 5 timepoints: baseline (2 visits), mid-treatment (1 visit), post-treatment (2 visits), 6-month follow-up (2 visits), and 12-month follow-up (2 visits). assessments will include the following for the adolescent and parent: anthropometry, emotion regulation, emotional inhibition, emotional eating, and adolescent-parent relationship measures. this program of research has the potential to advance the standard of practice for adolescents who are overweight or obese by providing alternative interventions. we are currently offering online treatment groups to accommodate the cdc health and safety guidelines.

Eligibility criteria:
inclusion criteria: * adolescent age 13-16 years * bmi percentile 85%85%-99.9% (adolescent only) * ability to read english at a minimum 6th grade level (both adolescent and parent); and willing to participate in a 6-month treatment and all assessments (both adolescent and parent) exclusion criteria: 1. current enrollment in a weight management program (child and parent); 2. medication that is specifically prescribed for weight loss (child and parent); 3. medical or psychiatric condition that may interfere with treatment participation (child and parent); 4. regular use of compensatory behavior for weight loss (e.g., purging) during the past six months (child and parent); 5. current pregnancy or lactating (child and parent); 6. change in psychotropic medication during the previous three months (child and parent).

Keywords: overweight obesity overeating treatment body mass index intervention behavioral treatment dialectical behavior therapy emotion regulation
detection of chemotherapy induced cardiotoxicity

Conditions: Cancer

Summary: to identify patients that are at risk of heart damage after receiving chemotherapy (adriamycin).

to identify patients at risk of development of heart damage after receiving chemotherapy by obtaining the genetic profile of those who show: elevation of troponin, left ventricular systolic and diastolic dysfunction, and pro-oxidant stress markers.

Eligibility criteria:
inclusion criteria: * undergoing anthracycline and/or trastuzumab therapy for the first time exclusion criteria: * abnormal ventricular ejection fraction * past history of, or active cardiac disease including: mi, chf, angina, arrhythmia requiring medication, valvular disease, uncontrolled systemic hypertension

Keywords: chemotherapy, cardiotoxicity
duloxetine versus pregabalin for alcohol dependence

Conditions: Alcohol Dependence

Summary: a 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d, duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and follow-up visits 1 week and 3 months post-treatment.


Eligibility criteria:
inclusion criteria: * males or females 18 years of age * meets dsm-iv criteria for current alcohol dependence and drinking an average of ≥21 drinks weekly for males, ≥14 females, * seeking research-based outpatient treatment for alcohol problems * willing to attend 12 weekly study visits and 2 follow-up visits * have normal bilirubin, and alt, ast, and ggt values no more than 3x the uln, and no evidence of hepatic insufficiency exclusion criteria: * active suicidal ideation * medical disorders that will increase potential risk or interfere with study participation * sexually active female subjects with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control * males who refuse to use a reliable method of birth control * meets dsm-iv criteria for any other current major axis i disorder other than alcohol or nicotine dependence. * inability to understand and/or comply with the provisions of the protocol and consent form * treatment with an antidepressant medication during the two weeks, or fluoxetine during the month, prior to randomization * ongoing treatment with disulfiram (antabuse), naltrexone (revia), acamprosate (campral) or other medications that may affect study outcomes, e.g., anticonvulsants or other drugs that act on serotonin in the brain * ongoing treatment with drugs that may increase potential risk (actos),

Keywords: alcohol alcohol treatment alcoholism alcohol abuse alcohol dependence
treatment of diabetic macular edema (dme) with anti-vegf and focal laser

Conditions: Diabetic Retinal Edema

Summary: long-term follow-up of patients with diabetic macular edema (dme) treated with intravitreal anti-vascular endothelial growth factor (anti-vegf) combined focal laser and identification of prognostic morphological characteristics.

long-term follow-up of patients with diabetic macular edema (dme) treated with intravitreal anti-vascular endothelial growth factor (anti-vegf) combined focal laser and identification of prognostic morphological characteristics. prospective clinical trial (50 treatment-naive eyes) with dme randomized 1:1 receiving intravitreal ranibizumab (0.5 mg/0.05 ml) and prompt grid laser compared to ranibizumab and deferred laser. morphological characteristics potentially relevant for prognosis were assessed at baseline, month 6, month 9, year 1, 2, 3, 4 and 5 of follow-up. grid laser and ranibizumab therapy is expected to be effective in dme management during long-term follow-up. immediate combined therapy will likely signify a trend of functional superiority in an early disease phase. intraretinal hyperreflective material in sd-oct will likely negatively related to bcva.

Eligibility criteria:
inclusion criteria: * dme that will be detected clinically and on fa as well as on sd-oct \[diffuse macular edema with central retinal thickness (crt) ≥300µm involving the center of the macular area\] * patients will be included into the present study following informed consent * best-corrected-visual-acuity (bcva) between 0.06 (1.2logmar) and 0.63 (0.20logmar). exclusion criteria: * eyes with other retinal diseases \[i.e. age-related macular degeneration (amd) and associated choroidal neovascularization (cnv), cystoid macular edema (cme) of other origin (e.g. uveitis, irvine-gass syndrome, retinal vein occlusion), or retinal dystrophies\]
gabapentin in the prevention of nausea and vomiting induced by chemotherapy

Conditions: Vomiting; Cisplatin Adverse Reaction

Summary: gabapentin is an antiepileptic drug. its antiemetic effect is demonstrated after laparoscopic surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy induced emesis. the purpose of this study is to determine whether the addition of gabapentin to dexamethasone plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.

this was a prospective, double-blind, placebo-controlled study conducted at our institution (faculdade de medicina da fundação abc and affiliated hospitals) from april 2009 to april 2010. patients and personnel involved in the study were blinded to the assigned treatment. the study was approved by the ethics committee of our institution. all the patients provided written informed consent.

Eligibility criteria:
inclusion criteria: * first course of chemotherapy ( cisplatin or doxorubicin at a dose of at least 50mg per square meter) * written informed consent must be obtained before initiating the protocol procedures exclusion criteria: * ecog 3 * nausea and vomiting within the past 1 day * gastrointestinal obstruction * concurrent use of opioid * patients with brain metastases * history of allergic or other adverse reaction to gabapentin

Keywords: vomiting antiemetics dexamethasone cisplatin antineoplastic combined chemotherapy protocols
study on registration of xinyuan capsule

Conditions: Coronary Disease

Summary: the purpose of this study is get to know what and how xinyuan capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.

in order to improving monitoring drug-induced liver injury or adverse drug reactions of chinese medicine containing radix polygoni multiflori in hospital, registry study is suitable method in this area. otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. safety surveillance on chinese medicine containing radix polygoni multiflori is an important problem that needs to be sorted out through large sample observational study. according to the relevant regulations of the cfda, 3000 cases need to be registered at least. the aim population is who using xinyuan capsule 's with abnormal liver function before medication from june 2017 to december 2018.

Eligibility criteria:
inclusion criteria: * patients using xinyuan capsule 's with abnormal liver function before medication from june 2017 to december 2018. exclusion criteria: * none.
diagnostic modalities for vap detection

Conditions: Ventilator Associated Pneumonia

Summary: asses diagnostic performance of different methods for detection of ventilator associated pneumonia.

ventilator associated pneumonia (vap) is a common cause of nosocomial infection, that can complicate mechanical ventilation and is related to significant utilization of health-care resources. the diagnosis of vap is subjected to considerable interobserver variability. the centers for disease control and prevention (cdc) definition of vap uses a combination of clinical, radiographic, and micro-biological criteria for diagnosis, but in the absence of a definite diagnostic test, the accurate diagnosis and treatment of vap is limited. the clinical pulmonary infection score (cpis) was developed to objectively diagnose vap and assign points on the basis of clinical and radiographic data, but its role in diagnosing pneumonia remains controversial . lung ultrasound (lus) is a simple, non irradiating, noninvasive, cost-effective, bedside technique. it has been successfully applied for monitoring aeration and monitoring antibiotic efficacy in ventilator-associated pneumonia (vap). however, no scientific evidence is yet available on whether lus reliably improves the diagnosis of vap. quantitative bacterial cultures of the specimen obtained from the lower airways using bronchoscope were proposed for vap diagnosis with a cut off value of 104 colony-forming unit/ml. however, microbiological cultures cannot guide the early clinical management of patients with a suspected vap, as they need at least 24 hours for preliminary results. so, starting antibiotics remains a challenge. moreover, bronchoscopy is not always easy to perform in hypoxemic patients and not promptly available in all icus. therefore, it can be replaced by tracheal aspirate microbiological samples.

Eligibility criteria:
inclusion criteria: * all adult patients mechanically ventilated for at least 48 hours in respiratory icu were included in the study. who had: * clinically suspected vap according to simplified clinical pulmonary infectious score exceeding 6. * or new or extension of a radiological image with at least two of the following clinical criteria: * body temperature ≥ 38.5 ° c or \<36 ° c. * leukocytes\> 10 \* 103 / ml or \ 10% immature cells (in the absence of other known causes). * purulent tracheal secretions. * hypoxemia with pao2 \<60 mmhg or a pao2 / fio2 \<300. exclusion criteria: * patients with diagnosis of community acquired pneumonia or hospital acquired pneumonia before starting of mechanical ventilation. * patients who are contraindicated for bronchoscopy
study in high risk patients switched from higher doses of other statins to crestor on the percentage of patients reaching the new ldl-c target goal

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to determine the efficacy of crestor in high risk patients switched from higher doses of other statins in obtaining the new european atherosclerosis society (eas) low-density lipoprotein cholesterol (ldl-c) guidelines.


Eligibility criteria:
inclusion criteria: * high risk patients * high doses of other statins * ldl-c known, starts with crestor 10 mg * permission to use patient data by astrazeneca (az)

Keywords: high risk patients crestor rosuvastatin ldl cholesterol observational
a phase ii trial of zio-101 in advanced multiple myeloma: protocol sgl2001b

Conditions: Multiple Myeloma

Summary: the study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma


Eligibility criteria:
inclusion criteria 1. subjects with a confirmed diagnosis of active multiple myeloma with measurable protein criteria present to evaluate response. measurable disease is defined as having at least one of the following criteria within 28 days prior to registration: 1. serum m-protein level \> 0.5 gm/dl (10.0 g/l) measured by serum protein electrophoresis. 2. urinary m-protein excretion \> 0.2 g/24 hours by urine electrophoresis. 2. subjects must have relapsed or resistant disease, defined as either relapsing or is resistant after \> 2 lines of prior therapy for myeloma. a minimum of 42 days must have elapsed since prior autologous or allogeneic transplant; 3. informed consent compliant with ziopharm policies and approved by the human investigation review committee with jurisdiction over the site; 4. ecog performance score ≤ 1; 5. no chemotherapy, bortezomib, lenalidomide, thalidomide, arsenic trioxide, radiation therapy or immune therapy for ≥ 3 w and recovered from all treatment associated toxicities prior to registration; 5a. patients may not receive more than the equivalent of 10 mg of prednisone per day for 2 weeks prior to registration. 6. age ≥ 18; 7. granulocytes ≥ 1.0 x 109/l; platelets ≥ 50 x 109/l; 8. bilirubin ≤ 2.0 mg/dl; ast and alt ≤ 2 x uln; 9. creatinine ≤ 3 x uln. 10. no investigational agents within 28 days of study entry. 11. males who agree to use a double-barrier method of birth control, (double barrier method is defined as: a condom and either a diaphragm/cervical cap or an iud). exclusion criteria 1. nyha functional class ≥ 3, myocardial infarction ≤ 6 mo or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; qtc ≥ 450msec; av-block ≥ grade-2 or lbbb; 2. women of childbearing potential. (non-childbearing potential is defined as: surgical sterilization or 2 years post-menopausal) 3. active infection requiring antibiotics; 4. allergy to zio-101 or its excipients; 5. baseline confusion or dementia, defined as grade \> 2 ctcae version 3.0; 6. significant neurotoxicityneuropathology, defined as grade \> 2 neurotoxicity neuropathology per ctcae version 3.0; 7. prior seizures ≥ grade-3 in ctc v.3 criteria. 8. prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment

Keywords: multiple myeloma arsenic cancer study failed treatment
lumbar erector spinae plane block and quadratus lumborum block in hip and proximal femur surgeries

Conditions: Postoperative Pain

Summary: multimodal analgesia is used to control postoperative pain in hip surgery. quadratus lumborum block is an effective regional anesthesia technique for hip and proximal femur surgery. the erector spinae plane block applied to the lumbar region was also reported to provide effective analgesia in these surgeons. in this study, we aimed to determine and compare the effects of quadratus lumborum block and lumbar erector spinae plane block on postoperative pain in hip and proximal femur surgeons.


Eligibility criteria:
inclusion criteria: - hip joint and proxiaml femur surgery, asa 1-2-3 exclusion criteria: * patient refusal * contraindications to regional anesthesia * known allergy to local anesthetics * bleeding diathesis * use of any anti-coagulants * inability to provide informed consent * severe kidney or liver disease * inability to operate pca system * patient with psychiatric disorders