Kornimate/medical-research-clean huggingface dataset:
treatment of thromboangiitis obliterans (buerguer's disease) with bosentan

Conditions: Thromboangiitis Obliterans

Summary: this study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (buerger's disease)patients. a clinical pilot study was designed,included in which patients with ulcer and/or pain at rest were treated with bosentan p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated to 125 mg twice daily. study endpoints were clinical improvement rate, major or minor amputation rate, hemodynamic changes, changes in endothelial function and angiographic changes. 12 patients were included were current smokers. with bosentan treatment, no new ischemic lesions were observed in all but one patient. overall, clinical improvement was observed in 12 of the 13 extremities (92%). only two of 13 extremities underwent amputation after bosentan treatment. as assessed by digital arteriography with subtraction or angio-magnetic resonance image an increase of distal flow was observed in 10 out of the 12 patients. all patients experienced a statistically significant improvement in their bafmd values (means:1.8 at baseline;6.6 at the end of the treatment;12.7 three months after the end of the treatment;p\<0.01). in conclusion: bosentan treatment may result in an improvement of clinical, angiographic, hemodynamic and endothelial function outcome. bosentan deserves further investigation in the management tao patients.


Eligibility criteria:
inclusion criteria: * critical ischemia in any extremity, causing pain at rest or non-healing ischemic ulcers, present for at least four weeks with no evidence of improvement in response to conventional treatment. exclusion criteria: * being candidates for surgical or endovascular revascularisation of the extremity studied.

Keywords: bosentan buerguer disease
serum 25-hydroxy vitamin d [25(oh)d] levels, supplemental vitamin d, and parathyroid hormone levels in premature infants

Conditions: Premature Infants

Summary: this study will determine levels of vitamin d supplementation to achieve goal serum 25-hydroxy vitamin d \[25(oh)d\] levels of 30 ng/ml, and to define serum 25(oh)d levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in newborn intensive care nursery (nicu). infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin d supplementation: 400 iu vitamin d3/day, or 800 iu vitamin d3/day.

the specific aims of this study are to determine levels of vitamin d supplementation to achieve goal serum 25(oh)d levels of 30 ng/ml, and to define serum 25(oh)d levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the nebraska medical center newborn intensive care nursery (nicu). in this randomized, controlled trial, infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin d supplementation: 400 iu vitamin d3/day, or 800 iu vitamin d3/day. as an exploratory aim, vitamin d binding protein levels (vdbp) will also be quantified in these infants.

Eligibility criteria:
inclusion criteria: * nicu hospitalized infants * 23-32 weeks gestation exclusion criteria: * congential anomalies * disorders of calcium metabolism * inborn error of metabolism * kidney disease * liver disease * use of steroids

Keywords: vitamin d3 prematurity parathyroid hormone 25(oh)d nicu hospitalization
biomarkers of diet-microbiota interactions in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: most patients suffering from the irritable bowel syndrome (ibs) report that ingestion of certain foods is a major trigger of symptoms, but the reason is unclear. previous studies have shown that foods containing poorly absorbed carbohydrates (fodmaps) are fermented by the bacteria in our bowels and these cause symptoms in some but not all patients. gut bacteria are capable of producing various products, such as neuroimmune mediator histamine, that may be related to ibs symptoms. our recent data suggest that consumption of fodmaps promotes production of bacterial histamine. the main objective of this study is to investigate bacterial production of histamine and its relationship to ibs symptoms. the study will involve 6 weeks on a low-fodmap diet with three three-day interventions consisting of high- or low-fodmap drinks along with probiotics or placebo capsules. the patient's bacteria and metabolites will be analyzed at various time points.


Eligibility criteria:
inclusion criteria: * adults aged 18-75 with ibs (rome iv criteria) who have self-reported previous improvement in their ibs symptoms while on a low fodmap diet, or when excluding certain high-fodmap foods, or patients in whom histamine is expected to play a key role (either diagnosed with high histamine producing bacteria, or improved ibs symptoms after using antihistamines). individuals should be able to swallow size 00 capsules. exclusion criteria: * concurrent significant organic gi pathology (i.e. celiac, ibd, etc.) * concurrent systemic disease (such as diabetes) and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection * history of active cancer in the last 5 years, other than basal cell cancer * pregnant or breastfeeding women * active or recent participation (\< 1 month) in a clinical study, except for spor imagine * use of antibiotics, probiotics, or ace inhibitors during, or one month prior to the study * use of new medications less than 4 weeks prior to the study. * allergies to any of the ingredients used in the study * any immune-compromising conditions

Keywords: fodmap microbiota histamine
traditional chinese medicine in individualized treatment of patients with diabetes symptoms

Conditions: Type 2 Diabetes Mellitus

Summary: based on the individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of traditional chinese medicine.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms. * after the diet and exercise therapy, 7.0mmol/l≤fpg≤11.1mmol/l or 8.0mmol/l\<2h pg\<16mmol/l * any type of tcm syndrome, but can be performed within the chosen chinese herbal medicine. * subject is willing to participate and capable of giving informed consent. exclusion criteria: * those patients used any drugs for treatment of diabetes within one month. * patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system. * patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month. * women who were pregnant, lactating or planned pregnant. * allergic constitution and has a history of drug allergy. * combined with severe acute or chronic infections.

Keywords: chinese herbal medicine diabetes symptoms
microarray analysis of microrna expression in basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: perturbations in microrna (mirna) expression profiles has been reported for a variety of cancers. this study will be an exploratory analysis of mirna expression in basal cell carcinoma by mirna expression profiling using microarrays.

perturbations in the expression profiles of micrornas (mirnas) have been reported for a variety of different cancers. basal cell carcinoma (bcc) of the skin has not been systematically evaluated regarding differentially expressed mirnas. patients with bcc are included in the study to perform an exploratory analysis by mirna expression profiling using microarrays. expression levels of mirna candidates will be validated by taqman real-time quantitative polymerase chain reaction (rt-pcr).

Eligibility criteria:
inclusion criteria: * basal cell carcinoma exclusion criteria: * other skin cancer than basal cell carcinoma
polyamine-free diet to prevent post surgery hyperalgesia

Conditions: Breast Cancer; Surgery

Summary: after surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain. it has been shown that n-methyl-d-aspartate (nmda) receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy. polyamines (putrescine, spermidine, spermine) are essential components of cells functioning and are also known as allosteric modulators of nmda receptors. in animal studies, polyamine-free diet has confirmed these antinociceptive properties. this research aims at evaluating anti hyperalgesic properties of polyamine-free diet in women operated on breast cancer versus kétamine

this multicentric, single blind study will enrol 160 women (18-75 years old) operated on tumorectomy and adenectomy (t1, t2, t3, n0, n1, m0) for breast cancer. patients will be randomly assigned in a 2x2 factorial plan : group 1 = control (n = 40) ; group 2 = ketamine group administered during and 48 hours after a standardized anesthesia (n = 40) ; group 3 = polyamine-free diet, 1 week and 72 hours after surgery (n = 40) ; group 4 : ketamine + polyamine-free diet (n = 40). the amount of morphine for the 24 first postoperative hours will be compared between each group as well as pain score, allodynia (von frey filaments) and hyperalgesia (algometer). chronic pain occurrence (post-mastectomy pain syndrome) will be evaluated at 3 and 6 months using adequate questionnaire ( analgesic scale). diet observance will be controlled preoperatively by a dosage of polyamines in circulating red cells blood. polyamines deprivation and ketamine ability to reduce postoperative pain will be compared (isobolographic method). anti-hyperalgesic properties of ketamine have already been demonstrated in urologic, orthopaedic and abdominal surgery. in case of additive or synergistic effect of a polyamine deprivation such a strategic could be helpful to achieve better postoperative rehabilitation in reducing chronic pain after surgery.

Eligibility criteria:
inclusion criteria: * breast cancer (t1, t2, t3, n0, n1, m0) * age : 18 - 75 * asa 1-3 * left or right tumorectomy with complete lymphadenectomy * left or right complete mastectomy with complete lymphadenectomy * complete lymphadenectomy within one week following simple tumorectomy * informed consent signed exclusion criteria: * inflammatory tumor requiring pre-operative radiotherapy * previous history of total mastectomy or partial contralateral mastectomy * chronic inflammatory disease treated by corticoids or nsai * chronic analgesic treatment * anti-arrhythmic or anti-epileptic treatments * morphinic treatment during the 7 days before surgery * excessive alcohol consumption or addiction * ketamine or neomycin contra-indication * severe cardiovascular disease

Keywords: polyamines pain breast cancer mastectomy post operative pain
a study of vismodegib (gdc-0449) in patients with locally advanced or metastatic basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: this is an open-label, non-comparative, multicenter, expanded access study of vismodegib (gdc-0449) in patients with locally advanced basal cell carcinoma (bcc) or metastatic bcc (mbcc) who are otherwise without satisfactory treatment options.


Eligibility criteria:
inclusion criteria: * for patients with mbcc, histologic confirmation of distant bcc metastasis * for patients with locally advanced bcc, at least one histologically confirmed lesion 10 mm or more in diameter and written confirmation from a surgical specialist that the tumor is considered inoperable or that surgery is contraindicated * for patients with locally advanced bcc, radiotherapy must have been previously administered for locally advanced bcc, unless radiotherapy is contraindicated or inappropriate. for patients whose locally advanced bcc has been irradiated, disease must have progressed after radiation. * patients with gorlin syndrome may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above * patients with measurable and/or non-measurable disease (as defined by recist) are allowed * adequate organ function * for women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of vismodegib (gdc-0449) * for men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of vismodegib (gdc-0449) exclusion criteria: * pregnancy or lactation * life expectancy \< 12 weeks * concurrent non-protocol-specified anti-tumor therapy * completion of most recent anti-tumor therapy at least 21 days prior to initiation of treatment * uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics * history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications * unwillingness to practice effective birth control
watchful waiting versus open tension-free repair of inguinal hernia in asymptomatic or minimally symptomatic men

Conditions: Inguinal Hernia

Summary: this is a multicenter clinical trial to compare pain, physical function, and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernias randomly assigned to watchful waiting without an operation, or a standard hernia repair with mesh. we studied the safety of delaying operation.

context many men with an inguinal hernia have minimal symptoms. whether deferring operation is safe and a good option for some patients has not been assessed. objective to compare pain and the physical component score (pcs) of the sf-36 at two years in men with minimally symptomatic inguinal hernias randomized to watchful waiting (ww) or a standard tension-free hernia repair (tfr). design, setting, and patients. between january, 1999 and december, 2004 we conducted a multicenter trial of 720 men (364 ww, 356 tfr) who were followed for 2-4.5 years. men were excluded with hernia pain interfering with activities; undetectable hernias; infection; american society of anesthesiologists physical status \>3; recent difficulty in reducing the hernia. interventions men assigned to ww were followed at 6 months and annually and watched for hernia symptoms. men assigned to operation received tfr, and were followed at 3 and 6 months, and annually.

Eligibility criteria:
inclusion criteria: men 18 years of age and older with asymptomatic or minimally symptomatic inguinal hernias who give informed consent to be randomized. - exclusion criteria:presence of pain limiting usual activities, difficulty in reducing hernia within last 6 weeks, undetectable hernias, local or systemic infection, asa physical status \>3, or participation in another clinical trial. -

Keywords: inguinal hernia asymptomatic watchful waiting tension-free hernia repair
a trial of cmna combined with preoperatie concurrent chemoradiotherapy for locally advanced escc

Conditions: Esophageal Neoplasms

Summary: this is a perspective, multicenter,single arm, open label study to evaluate the efficacy and safety of treatment with cmna combined with preoperatie concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . analyses of primary objective (pathologic complete response) will be done as defined in the protocol.

the primary end ponit of this study is pathological complete response.and the primary hypothesis is the cmna will improve patholofical response rate and thus improve os、dfs. assuming bilateral a=0.05, statistical power of 80%.the total sample size is 40 cases.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent prior to study entry 2. patients with escc in thoracic segment which is resectable（t2-3，n0-1，m0） confirmed by imaging and pathology or cytology; 3. patients have tumor lesions which can be objectively measured ,the length of tumor:≤8cm, the width of tumor:≤5cm;if the tumor cross the gej and violate the proximal stomach, the tumor must include esophagus and gej. the tumor is less than 2cm of the stomach 4. not infringe bronchial wall; no esophagus-tracheal fistula. 5. normal bone marrow reserve: anccount ≥1500/mm3;platelet count ≥100,000/mm3,hemoglobin≥9g/dl 6. normal hepatic funcion:bilirubin level ≤1.5×uln;ast/alt≤1.5×uln 7. normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min 8. normal cardiac function 9. ecog ps of 0 or 1 10. expected lifetime≥3 months 11. subjects tumor tissue available for the relevant biomarker detection exclusion criteria: 1. female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study. 2. any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae) 3. any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan 4. patients who have other malignant lesions, except curable skin cancer (non- melanoma skin cancer),carcinoma in situ of cervix or serve disease cured for 5 years 5. primary lesions were multifocal 6. patients with distant metastasis. a small amount of stomach tumor violate gej or the distal esophageal. 7. patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation 8. received anti-cancer treatment of esophageal cancer before the group, including surgery, radiotherapy, chemotherapy (induction of chemotherapy before the group is greater than or equal to two cycles). 9. cervical esophageal cancer confirmed by iconography 10. not esophageal squamous carcinoma confirmed by pathology or cytology 11. history of active hepatitis
a strength-based intervention to improve job interview skills in neurodiverse young adults

Conditions: ADHD; Dyslexia; Learning Disabilities

Summary: the investigators are looking to evaluate the effectiveness of a strength-based program in improving job interview skills in neurodiverse young adults. this program is designed to help participants understand and speak to others about their personal qualities and abilities. the investigators are examining the effects of this program in young adults who may have difficulty with job interviews, and who may want to improve these skills. some of these young adults have received special education services in the past for learning differences, such as attention deficit hyperactivity disorder (adhd) or dyslexia.

practicing job interview skills has been identified as an important target for job employment services in n-tay. however, the majority of studies using interventions in neurodiverse individuals have taken a deficit-based approach (i.e. to fix what is deficient in a person). this approach has triggered increasing criticism and dissatisfaction from the disability community. further, focusing on deficits will not result in identification, awareness, or expression of strengths, important skills needed for self-advocacy and transition to adulthood. kf-stride takes a strength-based approach, using principles of positive psychology to help n-tay identify and express their unique character strengths to future employers. over the course of a recently funded pilot study, the team has evaluated the efficacy of kf-stride in those on the autism spectrum. the investigators have found that individuals on the spectrum who train with kf-stride show improved job interview skills, and preliminary data indicates that they also have improved chances of obtaining employment in the community. however, kf-stride has never been evaluated in youth other than those on the spectrum, including those with adhd, dyslexia or other learning differences which may benefit from the training. the investigators aim to evaluate the preliminary effectiveness of kf-stride in a randomized controlled trial comparing kf-stride to services as usual (sau) to improve employment, as well as identify mechanistic targets which may lead to improved employment, and to evaluate the fidelity, acceptability, usability, and feasibility of the proposed intervention, kf-stride, via initial process evaluation.

Eligibility criteria:
inclusion criteria: * lives in the united states of america * between the ages of 14-26 speaks english well * at a 4th grade reading level exclusion criteria: * had a stroke, traumatic brain injury, or neurological injury or disease in the past(like brain tumor or epilepsy) * has a history of significant psychiatric illness(like schizophrenia or psychosis) * has uncontrolled seizures or other unstable medical complications
a study of avycaz (ceftazidime/avibactam) pharmacokinetics/pharmacodynamics (pk/pd) in critically ill patients

Conditions: Pharmacokinetics of Avycaz in ICU Patients

Summary: the purpose of this study is to analyze the pk/pd of avycaz in critically ill patients in the intensive care unit (12). this study will include medical and post-surgical patients who develop an infection where avycaz can be utilized. since these patients will have variable pk parameters, the investigators will also analyze (time-kill) these serum concentrations (ex vivo) against relevant clinical isolates (e.g. gnr with esbl or kpc) from the icu to determine microbiologic activity of avycaz in critically ill patients with variable characteristics. monte-carlo simulations will also be conducted against clinical icu isolates (jmi labs) to help determine appropriate dosing schedules based upon these pk parameters.


Eligibility criteria:
inclusion criteria: * adult (≥18y/o) patients with a medical or post-surgical infection such as skin/soft tissue infections, urinary infections, ia infections and pneumonia (including vap) * patients requiring intensive care (critically ill patients) in the med/surg icu (apache ii score ≥ 15) * patients prescribed avycaz for their infection will receive fda recommended dosages and times of administration * written informed consent exclusion criteria: * pregnant patients, patients older than 90 y/o, those with crcl \ 45 kg/m2, patients unable to provide serum samples, and those with the risk of imminent death during the study
opioid use and predicting factors at the emergency department

Conditions: Pain; Pain, Acute

Summary: background: increasing opioid misuse is a worldwide problem. about 10% of opioid misusers are primarily exposed to opioids at the emergency department (ed). this study was conducted to determine the feasibility for a clinical trial investigating the effect of virtual reality therapy on opioid consumption at the ed. methods: adult patients were included when primarily seen by the emergency physician and presenting with a nrs pain score ≥4. main objective was to identify the target population and evaluate outcome measures to sustain a trial incorporating the oral morphine equivalent (ome) at the ed as the primary endpoint. primary outcome was mean ome administered at the ed. secondary outcomes included nrs pain scores, main symptoms and type of analgesics administered at the ed.


Eligibility criteria:
inclusion criteria: * patient ≥16 years admitted to ed and identified by an emergency physician (ep) * nrs pain score ≥4 * patient is willing and able to comply with the study protocol exclusion criteria: * patients initially treated by another physician than the ep. * emv \< 14 * history of dementia, seizures * severe hearing/visual impairment not corrected * headwounds or damaged skin with which comfortable and hygienic use is not possible. * presentation to ed because of chronic pain (≥3 months) exacerbation * chronic opioids use (≥3 months)

Keywords: emergency department pain at rest opioid use