Kornimate/medical-research-clean huggingface dataset:
vitamin d supplementation on reported rates of taxane-induced neuropathy

Conditions: Neuropathic Pain

Summary: this is a two-arm randomized clinical trial in which 80 participants with vitamin d deficiency and scheduled to begin taxane-based chemotherapy will be randomized to either: 1) prescribed vitamin d replacement or 2) standard of care.

this is a two-arm randomized clinical trial in which 80 participants with vitamin d deficiency and scheduled to begin taxane-based chemotherapy will be randomized to either: 1) prescribed vitamin d replacement or 2) standard of care (advised to take over the counter (otc) vitamin d). all participants will have blood drawn for serum vitamin d analysis at weeks 4, 8, 12, and 24 in order to document vitamin d levels and titrate vitamin d dose (if needed in the treatment arm). participants in both arms will complete self-report measures of neuropathic pain at baseline, week 12, and week 24.

Eligibility criteria:
inclusion criteria: * diagnosis of stage i-iii cancer of any type, or diagnosis of stage iv cancer being treated with curative intent * receiving or scheduled to begin taxane-based chemotherapy at virginia commonwealth university (vcu) health massey comprehensive cancer center * vitamin d serum level \<20 ng/ml note: study participants with vitamin d serum level ≥20 ng/ml may be enrolled in the observational arm. exclusion criteria: * pre-existing diagnosis of neuropathy * currently taking prescription vitamin d (ergocalciferol) * inability to converse in english * pregnancy * chronic kidney disease (stage iv or greater) * known hyperparathyroidism * hypercalcemia: calcium levels \>10.5 mg/dl note: study participants with calcium levels \<10.5 mg/dl may be enrolled in the observational arm.

Keywords: neuropathic pain neuropathy vitamin-d
effect of different interventions on glycemic control and β-cell function in newly diagnosed type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2; Newly Diagnosed

Summary: the purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

one of the fundamental defects in type 2 diabetes mellitus is declining β-cell function. exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression. there are trials demonstrated efficacy, safety and tolerability of exenatide. however, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients. this current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * newly-diagnosed type 2 diabetic patients, drug naïve * age 30\~70 years * hba1c 7.0\~10.0% * bmi 20\~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening * female patients of reproductive age should practice a reliable method of birth control throughout the study exclusion criteria: * acute or severe chronic diabetic complications * congestive heart failure (nyha grade ⅲ\~ⅳ) * severe gastrointestinal disease * severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation * other severe intercurrent illness * serum aminotransferase (alt and ast) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/l (1.5mg/dl) * tested positive for glutamic acid decarboxylase antibody * use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug * history of pancreatitis * serum triglyceride ≥ 5.0 mmol/l * pregnancy

Keywords: diabetes mellitus, type 2 newly diagnosed exenatide premixed insulin analog thiazolidinedione β-cell function glycemic control
cd40-l blockade for prevention of acute graft-versus-host disease

Conditions: Graft-versus-host-disease; GVHD; GVHD, Acute

Summary: the purpose of this study is to examine the safety and efficacy of the addition of bms-986004 to standard of care sirolimus (sir)-based immune suppression.

the approach builds upon extensive evidence supporting the benefit of cd40l blockade in disrupting key signaling events associated with immune activation. the trial addresses a pressing clinical need, namely prevention of graft-versus-host disease (gvhd) after hematopoietic cell transplantation (hct) and promotion of donor-recipient immune tolerance. the safety profile of this anti-cd40l antibody overcomes major prior limitations, and the planned biologic studies will provide significant mechanistic insight.

Eligibility criteria:
inclusion criteria: * hematologic malignancy or blood disorder requiring allogeneic hct * adequate vital organ function as defined per protocol * karnofsky performance status score (kps) ≥ 80% * participants must have an available 8/8 hla-a, -b, -c, and -drb1 matched-related or unrelated donor exclusion criteria: * active infection not controlled with appropriate antimicrobial therapy * hiv, hepatitis b or c infection or known history of hiv, hepatitis b or c(all patients will be tested for hiv, hepatitis b and c as part of standard pre-transplant testing, and will be excluded from this trial if positive) * anti-thymocyte globulin, or cyclophosphamide administered within 14 days before or planned to receive with hct conditioning or as part of gvhd prophylaxis in the 14 days after hct * known allergic reactions to components of the study drug * concurrent treatment with another investigational drug * history of thromboembolism, transient ischemic attack, stroke, myocardial infarction within 3 months preceding the transplant, or uncontrolled congestive heart failure or cardiac arrhythmias. * post-transplant maintenance therapies such as flt3 inhibitor, tyrosine kinase inhibitor, jak inhibitors etc. are not allowed if plan is to initiate such therapies \<90 days post-transplant. patient will be eligible if plan to initiate maintenance therapy is after day 90 post-transplant.

Keywords: hct hematopoietic cell transplantation antibody therapy
a study of plazomicin compared with meropenem for the treatment of complicated urinary tract infection (cuti) including acute pyelonephritis (ap)

Conditions: Complicated Urinary Tract Infection; Acute Pyelonephritis

Summary: this was a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (po) therapy in the treatment of cuti, including ap, in adults.


Eligibility criteria:
key inclusion criteria: * pyuria * have a pretreatment baseline urine culture obtained within 36 hours before the start of administration of the first dose of study drug * clinical signs and/or symptoms of acute pyelonephritis or complicated urinary tract infection * normal renal function or moderate renal impairment key exclusion criteria: * confirmed fungal urinary tract infection at the time of randomization * known urinary tract infection or colonization with gram-positive pathogens * current cuti or ap is known to be caused by a pathogen resistant to meropenem * female participants of childbearing potential if they are known to be pregnant or have a positive pregnancy test at screening, breastfeeding, or unable or unwilling to use a highly effective method of birth control during the study and for at least 30 days following the last dose of study medication * any rapidly progressing disease or immediately life-threatening illness * documented presence of immunodeficiency or an immunocompromised condition * documented or known history of otologic surgery or disease including use of hearing aid, head injury leading to otologic damage, ménière's disease, tumor of the head, neck, or auditory system, perilymphatic fistula, or autoimmune disease of the inner ear, or family history of hearing loss (excluding age-related hearing loss \[onset after age of 65 years\])

Keywords: cuti ap achn-490 anti-infective anti-bacterial antibiotic anti-microbial uti bacterial infection gram-negative
efficacy of l-ornithine l-aspartate (lola) as an adjunct to branched chain amino acids (bcaa) enriched solutions on clinical outcomes in icu patients with hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: one of the most significant goals of hepatic encephalopathy (he) treatment is to reduce ammonia levels by lowering its synthesis and enhancing its detoxification which can be achieved by using non-absorbable disaccharides, antibiotics, branched-chain amino acids (bcaa), l-ornithine l-aspartate (lola), and probiotics. lola decreases ammonia, therefore, it is presumed to decrease agitated delirium in he patients and thus decrease their need for other sedatives. on the other hand, bcaa improve mental function in he patients by increasing the detoxification of ammonia in muscles.

the most often utilized criteria for grading he are the west haven criteria (whc). this grading distinguishes four levels of clinically evident hepatic encephalopathy. west haven criteria (whc): \[r\] stage consciousness 0. normal 1. mild lack of awareness 2. lethargic 3. somnolent but arousable 4. coma references: ferenci p, lockwood a, mullen k, tarter r, weissenborn k, blei at. hepatic encephalopathy-definition, nomenclature, diagnosis, and quantification: final report of the working party at the 11th world congress of gastroenterology, vienna, 1998. hepatology 2002; 35: 716-21.

Eligibility criteria:
inclusion criteria: * patients diagnosed with liver cirrhosis based on clinical, biochemical, radiological and/or histopathology. * patients having overt he, west haven criteria (whc) grade iii-iv. exclusion criteria: * age \< 21 years. * inability to obtain an informed consent from the first degree relative and/or legally authorized representative. * advanced cardiac or pulmonary disease. * presence of underlying chronic renal failure (serum creatinine \> 3 mg/dl). * neurodegenerative disease (including head injury and drug intoxication). * major psychiatric illness. * use of sedatives or antidepressants. * pregnancy or breast-feeding . * hepatocellular carcinoma. * acute on top of chronic liver failure.
the use of a us-measured styloid process of the distal radius eet diameter for prediction of ett size

Conditions: Airway Management

Summary: this study will aim to test the accuracy of the ultrasonography measurement of the epiphyseal diameter of the distal radius in the prediction of the size of the cuffed and uncuffed ett that best fits in children (1-6 years old) in comparison with the traditional age-based formulas.

various formulas are used to predict the inner diameter (id) of the ett tube whether uncuffed or cuffed based on weight, age, height, and finger size. the accuracy of these formulas is questionable. these formulas depend on the child's demographic characteristics assuming that he/she has normal growth and development and cannot be applied to children with altered growth and development. moreover, these formulas predict the id of the ett ignoring the tube thickness and the od of the selected tube. ultrasound has recently been identified as an accurate alternative to these formulas. the us-measured epiphyseal diameter of the distal radius is a method that has been recently introduced as a surrogate for the tracheal diameter. the issue is that the size of the airway can be considered a reflection of the body's growth, assuming that the growth rates of the cartilage all over the body are closely related to each other. therefore, the measurement of the growth of the bony cartilage of the hand can be considered a surrogate marker of the tracheal diameter.9 the extent to which ultrasonography by this method can succeed in predicting the optimal pediatric ett size remains under investigation.

Eligibility criteria:
inclusion criteria: * weight: 10-30 kg. * age: 1-6 years. * sex: both males and females. * asa physical status: i-ii. * operation: elective surgery in which airway management with an endotracheal tube is needed. exclusion criteria: * upper airway malformations. * upper airway surgery. * active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia, * anticipated difficult airway.

Keywords: children, airway, ett, us, radial diameter
non-pharmacological prevention of stroke in patients with non-valvular atrial fibrillation

Conditions: Atrial Fibrillation

Summary: left atrial appendage (laa) occlude devices are used for over ten years. according to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular atrial fibrillation. however, to date, laa occluder implantation is not recommended as an alternative for conservative therapy and reserved for patients with contraindications for oral anticoagulants only. in the same time, long-term follow-up of patients enrolled in clinical trials and data from registries showed that laa occlude device implantation as an alternative to oral anticoagulation could reduce drug load, decrease complexity and cost of treatment and thus improve patients' quality of life, and potentially may reduce the risk of death. the aim of our study is to investigate the risk of all-cause death, stroke, and bleedings in patients with laa occluder implanted as an alternative to anticoagulant therapy. three hundred patients with atrial fibrillation will undergo laa occluder implantation. for laa occluder sizing transesophageal echocardiography (tee), ct and laa angiography will be performed. the follow-up period will be 36 months. the incidence of all-cause death, stroke, bleeding barc≥2, device-related complications and qol will be investigated. the patients will be followed in the clinic at three and six months, and then at 12, 24 and 36 months, the telephone calls for getting information about endpoints events will be done. additional in clinic visits will be scheduled if the late complications will be suspected. tee will be performed at three and six months to check for device leak, displacement and thrombosis.


Eligibility criteria:
inclusion criteria: * patient with paroxysmal/persistent/permanent atrial fibrillation * cha2ds2vasc score ≥2 for male and ≥3 for female * without contraindications to anticoagulation therapy exclusion criteria: * laa thrombosis * mechanical prosthetic heart valve * moderate or severe mitral valve stenosis

Keywords: left atrial appendage laa occluder thromboembolic prophylaxis atrial fibrillation
a study of rosiglitazone plus insulin to treat type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Summary: this study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.


Eligibility criteria:
inclusion: * patients with type 2 diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks * if patients are taking another oral antidiabetic agent may stop their oral agent and adjust their insulin dose properly over 8 weeks prior to screening if they are asked by doctor who considers him/her suitable for study in all other respects, and the hba1c level\>7.5%. exclusion: * fasting plasma glucose \>13 mmol/l at screening * ongoing edema or history of peripheral edema requiring pharmacological treatment within 12 months * drug abuse * women pregnant or lactating * use any rosiglitazone like drug in 3 months * use more than one oral antidiabetic agent in 2 months * uncontrolled hypertension * chronic heart failure * anemia

Keywords: insulin brl49653 /rosiglitazone type 2 diabetes mellitus
improving visual attention in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this study investigates whether visual attention can be improved in individuals with schizophrenia by stimulating the brain via transcranial direct current stimulation (tdcs).

individuals with schizophrenia tend to display abnormal visual attention when performing visual tasks, typically spending less time on salient features of the stimuli (e.g. core facial features or body movement in social tasks), and instead focusing on idiosyncratic features of an image or video. poor visual attention in schizophrenia has been directly linked to poorer social cognitive performance (e.g. recognizing emotional expressions or social cues) which can impact an individual's day to day functioning. transcranial direct current stimulation (tdcs) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric disorders. tdcs in schizophrenia has been demonstrated to improve a wide range of cognitive processes, and in healthy adults, tdcs has been demonstrated to improve aspects of social cognition. tdcs thus appears to be a promising therapeutic technique that may be useful for improving visual attention in patients with schizophrenia, and potentially impact social cognitive performance via an underlying mechanism tying the two. this study will compare visual performance in individuals with schizophrenia across two conditions: active anodal tdcs and sham tdcs, while also comparing between brain stimulation sites: rtpj and dmpfc.

Eligibility criteria:
inclusion criteria: * dsm-iv-tr or dsm-5 diagnosis of schizophrenia or schizoaffective disorder and clinically stable (i.e. no hospitalizations) for at least 8 weeks prior to informed consent and be on a stable medication regimen for at least 6 weeks with no dose changes for a minimum of 2 weeks prior to informed consent. exclusion criteria: * the presence or history of a pervasive developmental disorder or mental retardation as defined by a premorbid iq \< 70 * presence or history of medical or neurological disorders in which neural stimulation would be contraindicated (e.g. presence of epilepsy or history of seizures) * presence of sensory limitations, including visual or hearing impairments that interfere with assessment * history of electroconvulsive therapy * not proficient in english * presence of substance abuse in the past one month or dependence not in remission in the past six months
pthrp and osteoporosis

Conditions: Osteoporosis

Summary: pth-related protein, or ''pthrp'', is a hormone which was discovered in 1987. as its name implies, it is closely related to another hormone discovered in the 1920's named parathyroid hormone or ''pth''. pth has been shown to be effective in treating osteoporosis in both animals and humans. pthrp has been shown to be effective in treating osteoporosis in laboratory animals, and there are strong scientific reasons to think that it may be effective in humans as well. however, no human trials with pthrp in the treatment of osteoporosis have been performed. the studies in this trial are focussed on determining whether pthrp can indeed increase bone mass in postmenopausal women with osteoporosis, when administered daily by subcutaneous injection for three months.


Eligibility criteria:
inclusion criteria: * healthy caucasian postmenopausal females between 50-75 years of age with low bone mineral density at the lumbar spine or hip as measured using dual energy x-ray absorptiometry or dxa. * on estrogen replacement treatment for at least three years. exclusion criteria: * heart, vascular, kidney, liver, lung, hormonal, musculo-skeletal disease (other than osteoporosis), rheumatic, blood diseases are exclusion criteria. * high blood pressure * pregnancy * cancer * alcohol or drug dependence * prior use of a drug treatment for osteoporosis such as pth, bisphosphonates, raloxifene, or calcitonin within the preceding five years

Keywords: parathyroid hormone-related protein parathyroid hormone anabolic skeletal therapy postmenopausal women
gemcitabine and docetaxel with radiation in adults with soft tissue sarcoma of the extremities

Conditions: Soft Tissue Sarcoma

Summary: the purpose of this phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation.

primary objective: • to determine the maximum tolerated doses gemcitabine and taxotere when given weekly with concurrent radiation in the neoadjuvant setting for patients with soft tissue sarcoma of the extremities. secondary objective: • to evaluate immunological changes induced by gemcitabine and docetaxel with radiation in patient with high risk-soft tissue sarcomas in blood. this would include t cell subsets, nk, and dendritic cells and tumor macrophages all of which make up the tumor microenvironment. long term follow-up will occur every 3-4 months for 24 months in person or video consultation.

Eligibility criteria:
inclusion criteria: * patients must have a histologically or cytologically confirmed grade ii or iii soft tissue sarcoma that is considered to be resectable and are candidates for pre-op radiation. * age greater than or equal to 18 years. no children will be enrolled on this protocol. * eastern cooperative oncology group (ecog) performance status less than or equal to 2. * women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives. * patients taking an investigational agent are excluded. * pregnant and nursing women are excluded. * patients who require amputation for local control. * patients who underwent unplanned excision or other previous surgery involving the affected extremity. * patients with sarcoma subtypes for which established chemotherapeutic regimens exist. * history of radiation to the limb.

Keywords: grade ii sarcoma grade iii sarcoma
aortic stenosis with complex pci (ascop) features retrospective registry on contemporary management and outcomes

Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; Angioplasty, Balloon, Coronary; Coronary Artery Disease

Summary: to describe the prevalence and clinical features of patients with severe aortic stenosis undergoing tavi and concomitant clinically indicated, complex and/or high-risk pci

the aims of this study are: * to describe the prevalence and clinical features of patients with severe aortic stenosis undergoing tavi and concomitant clinically indicated, complex and/or high-risk pci * to depict the different possible strategies that are currently employed in this context and to retrospectively analyze outcomes * to investigate predictors of better outcomes

Eligibility criteria:
1. severe, symptomatic aortic stenosis with an indication to tavi 2. concomitant, stable cad with an indication to complex pci, as anticipated by angiography, defined as follows (one or more features) 1. left-main (lm) cad or proximal left anterior descending (lad) / left circumflex (lcx) lesions requiring lm-pci 2. three-vessel disease 3. last remaining vessel 4. bifurcation pci (proximal bifurcation) 5. severely calcified lesions requiring calcium plaque modification (rotational/orbital atherectomy, intravascular lithotripsy, scoring or cutting balloon) 6. lesion length \> 30 mm 7. severely depressed left ventricular function requiring mechanical circulatory support (intra-aortic balloon pump - iabp, impella, extracorporeal membrane oxygenation - ecmo