Kornimate/medical-research-clean huggingface dataset:
study to test the value of a pain modulation test in predicting persistent postoperative pain after breast cancer surgery

Conditions: Chronic Pain; Acute Pain

Summary: the purpose of this study is to test the hypothesis that a preoperative test of pain modulation predicts persistent pain 4 months after breast cancer surgery. in addition, a risk score for the prediction of persistent pain will be developed from parameters available before surgery.


Eligibility criteria:
inclusion criteria: * age \>=18 years * american society of anesthesiology functional status i-iii * able to read and understand the information sheet and give informed consent exclusion criteria: none
support through remote observation and nutrition guidance program (strong-pcs)

Conditions: Pancreatic Cancer

Summary: the purpose of the study is to assess the feasibility and participant satisfaction with the support through remote observation and nutrition guidance program. the program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery.


Eligibility criteria:
inclusion criteria: * ≥18 years old * diagnosis of pancreatic cancer * completed open pancreatic surgery (e.g., whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at moffitt cancer center * discharged on an oral diet * able to speak and read english or spanish * able to provide informed consent exclusion criteria: * determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)

Keywords: nutrition support
envarsus neurotoxicity burden in liver transplant patients

Conditions: Neurotoxicity; Liver Transplant; Complications

Summary: this study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. the standard therapy of twice daily immediate release tacrolimus will be compared to envarsus once daily. we hypothesize that envarsus will show a lower rate of neurologic side effects than immediate release tacrolimus.


Eligibility criteria:
inclusion criteria: 1. male or female adult (≥18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant. 2. patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study. exclusion criteria: 1. patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner 2. hiv positive (hiv ab +) 3. unable to tolerate oral medications 4. use of another investigational product within thirty days prior to receiving study medication 5. moderate acute cellular rejection (rai ≥ 5) within the past month 6. a condition that is known to cause tremor such as essential tremor, parkinson disease, or enhanced physiologic tremor. 7. patients taking medications known to induce tremors or dopamine blocking agents 8. a condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
the safety, tolerability, and effectiveness of quetiapine in postpartum depression

Conditions: Postpartum Depression

Summary: postpartum depression is a serious disorder that affects approximately 14% of women who have recently given birth. postpartum depression is either an episode of major depressive disorder (only low periods) or bipolar disorder (periods of lows and highs). untreated postpartum depression can negatively affect the mother, the infant and the family. antidepressants are the most used treatments; however, for many women these drugs are not useful, resulting in a pressing need for effective treatments for postpartum depression. lack of sleep is common after delivery and can trigger depression in some women. quetiapine, a drug used for bipolar disorder, major depressive disorder and occasionally sleeplessness has not been well studied in postpartum depression. this study aims to find out how mothers tolerate the drug and whether it is effective for postpartum depression. results of this study may help investigators carry out a larger study comparing quetiapine and placebo (a sugar pill) in postpartum depression.


Eligibility criteria:
inclusion criteria: * outpatient woman between ages 18 - 45 * within 6 months of delivery * have a dsm-5 diagnosis of mdd or bd i, bd ii or other specified bipolar or related disorder with peripartum onset * have a score of \>18 on the 17-item hamilton depression rating scale (hdrs) * have a score of ≤12 young mania rating scale (ymrs) at both the screening and baseline visits * able to communicate in english * capable of providing informed consent exclusion criteria: * a diagnosis of schizophrenia spectrum or other psychotic disorders, obsessive-compulsive disorder, eating disorders, substance-related and addictive disorders * at high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the hdrs) * receiving a psychotropic drug such a mood stabilizer, an antidepressant or a sedative/hypnotic. * receiving psychotherapy * have a physical illness that is a contraindication to the use of quetiapine, or who have a history of intolerance or nonresponse to quetiapine * pregnant or planning on becoming pregnant during the study

Keywords: quetiapine postpartum drug therapy major depressive disorder
efficacy and pharmacokinetics of meropenem in severe septic patients

Conditions: Sepsis

Summary: the experimental and control group were used different administration of meropenem through monitoring the meropenem plasma concentration and clinical data

this study is a prospective, randomized controlled trial, which the subjects were severe sepstic patients for selecting meropenem as antimicrobial drugs. the experimental and control group were used different administration of meropenem through monitoring the meropenem plasma concentration and clinical data, eventually demonstrate the effecacy and safety of meropenem in patients with severe infection and optimize the best clinical practice for antimicrobial agents.

Eligibility criteria:
inclusion criteria: 1. inpatients, whose informed consent has been obtained; 2. clinical diagnosis of sepsis exclusion criteria: 1. pregnancy or lactation; 2. treated with other carbapenems; 3. cannot be evaluated for efficacy and safety result from lack of clinical and laboratory parameter for infection assessment; 4. allergy to meropenem or other β-lactams, or the history of allergy; 5. resistant to meropenem according to the antimicrobial susceptibility test; 6. epilepsy or history of epilepsy; 7. history of seizures; 8. combined medicine with sodium valproate; 9. combined medicine with anti-mrsa, anti-fungal drugs; 10. with severe liver or renal dysfunction; 11. terminal cancer; 12. septic shock; 13. apach ii ≥20; 14. inappropriate to participate in the trial evaluated by investigator.

Keywords: sepsis，meropenem，2 steps administration
a study to evaluate the efficacy and safety of cc-93538 in adult and adolescent japanese participants with eosinophilic gastroenteritis

Conditions: Eosinophilic Gastroenteritis

Summary: the purpose of this study is to evaluate the safety and efficacy of cc-93538 in adult and adolescent participants with eosinophilic gastroenteritis.


Eligibility criteria:
inclusion criteria: * histologic evidence of eosinophilic gastroenteritis (ege) defined as ≥ 30 eosinophils (eos)/high-power field (hpf) in at least 5 hpf in the stomach and/or ≥ 30 eos/hpf in at least 3 hpf in the duodenum while on stable background therapy for ege * has weekly symptom scores of ≥ 4/15 for any of gastric pain symptoms domain, stomach heaviness symptom domains, and /or diarrhea symptoms domain as assessed by the izumo scale with electronic device for the 2 consecutive weeks before day 1 * must agree to maintain a stable diet from the first screening visit and throughout the duration of the study, and participants must have maintained a stable diet for at least 4 weeks prior to the first screening visit * females of childbearing potential must have 2 negative pregnancy tests as verified by the investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose exclusion criteria: * ascites requiring treatment or symptomatic ascites * history of inflammatory bowel disease, achalasia or esophageal surgery * has other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (egpa) other protocol-defined inclusion/exclusion criteria apply

Keywords: eosinophilic gastroenteritis cc-93538 gastrointestinal diseases eosinophilic gastro-intestinal disorder egid digestive system diseases gastroenteritis
fibreoptic bronchoscopy assisted intubation during noninvasive positive pressure ventilation

Conditions: Respiratory Failure

Summary: this study is to investigate the efficiency and safety of fibreoptic bronchoscopy assisted intubation during noninvasive positive pressure ventilation in respiratory failure patients. half of the participants will receive preoxygenation with noninvasive ventilator and fibreoptic bronchoscopy intubation during nippv. while the other half using usual preoxygenation(bag-mask ventilation ).

respiratory failure is very common for critically ill patients, main complication associated with intubation was desaturation. usual preoxygenation( bag-mask ventilation) have been show that marginally effective in critically ill patients. as a result, there is a need to optimize the technique of preoxygenation to prolong the safe duration of apnea during the intubation procedure in critically ill patients. noninvasive ventilation provides continuous positive airway pressure is effective in increasing the efficiency of gas exchange and in reducing the decrease in oxyhemoglobin saturation during fiberoptic bronchoscopy in hypoxemic patients. therefore, our aim was to study whether nippv is more effective at reducing desaturation than usual preoxygenation in hypoxemic, critically ill patients requiring intubation in icu.

Eligibility criteria:
inclusion criteria: * acute respiratory failure requiring intubation, * age greater than or equal to 18 years exclusion criteria: 1. nasal polyps，nasopharyngeal cancer，nasal bleeding，rhinitis，sinusitis and so on nasal disease 2. basal skull fracture 3. severe coagulopathy, blood platelet counts \<50×10\*9/l 4. nose and facial deformities, trauma 5. cardiac arrest 6. pregnancy or puerpera

Keywords: bronchoscopy intubation noninvasive positive pressure ventilation
scleroderma registry

Conditions: Systemic Sclerosis; Scleroderma

Summary: scleroderma is likely caused by a combination of factors, including an external trigger (infection or other exposure) and a genetic predisposition. the scleroderma registry will conduct genetic analyses for disease-related genes in patients with scleroderma and their family members (parents, brothers, and sisters).

scleroderma refers to a group of diseases that involve the abnormal growth of connective tissue, which supports the skin and internal organs. scleroderma can affect the skin, making it hard and tight; it can also damage the blood vessels and internal organs such as the heart, lungs, and kidneys. estimates for the number of people in the united states with the systemic (body-wide) form of scleroderma range from 40,000 to 165,000. the number of people with all scleroderma-related disorders is between 250,000 and 992,500. researchers believe that several factors interact to produce scleroderma, including abnormal immune activity, potential environmental triggers, and genetic makeup. scleroderma is not passed on from parents to child, but certain genes may make a person more likely to develop the disease. the goals of this project are to identify the genes that influence disease susceptibility and expression in systemic scleroderma and to establish a repository of dna, plasma, and serum samples from single case scleroderma families, multicase families, and healthy unrelated volunteers for the use of researchers interested in studying this disease. participants in the registry will have a phone interview regarding disease characteristics and family history. participants will be sent a blood kit to get a blood sample drawn locally for shipment to the registry lab. blood samples will be made available (anonymously) for studies by researchers around the country. in some cases, participants will be asked to sign a release of medical information so that medical records can be obtained to verify the diagnosis. as of may 2009, this study is no longer enrolling family members.

Eligibility criteria:
inclusion criteria * diagnosis of systemic sclerosis or family members of patients with systemic sclerosis or * healthy volunteer with no autoimmune disease and without a first-degree relative with a systemic autoimmune disease

Keywords: genetic study transmission dysequilibrium testing genome wide scan family study
identification of a molecular signature in locally advanced cervical cancer patients

Conditions: Cervical Cancer

Summary: the importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. however, to date, no study has analyzed the role of the gene expression signature of the three rna species (anxa2-ndrg1-stat1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive ctrt. the previously validated three-gene signature may enable stratification in lacc patients treated with the current standard of care, represented by exclusive ctrt.

the importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. several biomarkers of cervical cancer radioresistance have been previously studied and proposed; however, none of these has been the subject to further clinical studies and implemented into clinical practice. recently, a panel of three protein coding genes (anxa2-ndrg1-stat1) differently expressed in radiosensitive lacc patients compared with the radioresistant ones, has been proposed by our institution. the population of lacc patients included in a previous study was treated with neo-adjuvant ctrt followed by radical surgery. however, to date, no study has analyzed the role of the gene expression signature of the three rna species (anxa2-ndrg1-stat1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive ctrt. the previously validated three-gene signature may enable stratification in lacc patients treated with the current standard of care, represented by exclusive ctrt.

Eligibility criteria:
inclusion criteria: * age \> 18 years * histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix * figo 2018 stage iib and iiic1\[38\] * treatment with exclusive chemoradiation including brachytherapy * has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer * has radiographically evaluable disease, measurable per recist 1.1 * negative pregnancy test * adequate hematologic, renal, and hepatic functions, with following blood tests: neutrophils \> 1500/μl platelets \> 100.000/ μl hemoglobin \> 9 g/dl serum creatinine \< 1.8 mg/dl total bilirubin \< 3 mg/ dl ldh \< 3x normal value got \< 3x normal value gpt \< 3x normal value alp \< 3 x normal value exclusion criteria: * rare cervical cancer histologies (neuroendocrine, glassy cells, serous, endometrioid etc) * neo-adjuvant treatment * patients included in other clinical trials * patients refusing to sign informed consent * contraindications to radiotherapy * contraindications to pelvic radiotherapy: ulcerative colitis, diverticulitis, chronic pelvic inflammatory disease, previous pelvic radiotherapy
children born preterm: sustainable health monitoring

Conditions: Premature Birth

Summary: children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. however, in italy as well as in tuscany, such a follow up is not usually done, and data are not collected in a structured way. the goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. the main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • what is the role of prenatal and perinatal factors in influencing access to care during childhood? participants will be asked to attend a follow-up visit for the purpose of collecting health data.


Eligibility criteria:
inclusion criteria: * children born preterm (gestational age below 37 weeks at birth) in tuscany region * acquisition of the informed consent exclusion criteria: * residing outside tuscany region
unintentional overfeeding of formula fed infants

Conditions: Childhood Obesity; Infant Development

Summary: although breast milk is recommended exclusively until 6 months of age, two-thirds of infants in the u.s. are fed infant formula. despite an almost identical energy density between infant formula and breast milk, formula fed infants experience greater weight gain in the first year of life. the investigators propose that unintentional overfeeding, of nearly one additional day of calories per week, due to the "over-scooping" of powdered formula contributes significantly to this phenomenon and potentially to the early development of childhood obesity, a significant public health problem.

in the proposed study the investigators will assess the literacy and understanding of individuals to follow commercially available infant formula instructions. the investigators will collaborate with the la cats health literacy core to improve the reading and comprehension of the manufacturer package instruction, and will solicit the input of caregivers and key stakeholders to inform the development of educational intervention around infant feeding. following modification of infant formula preparation instructions, the investigators will conduct a randomized controlled trial that will test the efficacy of the modified instructions on infant overfeeding in comparison with the manufacturer package instructions. one hundred and fifty participants will be asked to complete one study visit during which they will be asked to measure various serving sizes of infant formula following either the manufacturer package instructions or the modified instructions.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * willing to participate in 1 assessment visit at pennington biomedical research center * english speaking exclusion criteria: * \<18 years of age * not willing to participate in 1 assessment visit at pennington biomedical research center * non-english speaking

Keywords: infant formula
effects of playing video games on energy balance

Conditions: Obesity

Summary: the aim of this study is to examine the effects of playing video games on various components of energy balance and substrate metabolism as well as on glucose homeostasis and relevant hormonal systems that might be involved in the underlying mechanisms.


Eligibility criteria:
inclusion criteria: * male adolescents between 15 and 19 years of age * normal weight (5th percentile to less than the 85th percentile) exclusion criteria: * smoking * unstable body weight (±4 kg) during the 6 months preceding testing * regular physical exercise (\>3 hours/week) * excessive intake of alcohol (\>7 drinks/week) * substance abuse * metabolic disease (e.g. thyroid disease, heart disease, diabetes, etc.) * medication that could interfere with the outcome variables * eating disorder * high restraint eating behavior (score ≥8 for cognitive dietary restraint in the three-factor eating questionnaire) * irregular eating schedule (e.g. skipping breakfast) * unfamiliar with the use of video games * unable to comply with the protocol

Keywords: video games energy balance metabolism appetite control
efficacy and safety study of zometa® in treatment of high-level ntx non small cell lung cancer with bone metastasis

Conditions: Non Small Cell Lung Cancer; Bone Metastases; High NTX Level

Summary: a multicenter prospective study to assess the efficacy and safety of zometa® in treatment of high-level ntx non small cell lung cancer with bone metastasis.


Eligibility criteria:
inclusion criteria: * age \> 18 * histologically confirmed non-small cell cancer * one bone metastasis at least confirmed by image(x ray, ct or others) * ntx \> 50nm bce/mm creatinine * life expectancy \> 6 m * ecog \<= 2 * signed icf exclusion criteria: * women who are pregnant or in lactation * patients with hyperostosis with brain metastasis(exception of those without symptom or with metastasis lesions under controlled * previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy * severe co-morbidity of any type that may interfere with assessment of the patient for the study -

Keywords: non small cell lung cancer ntx zometa
treatment of ad with ige specific immunoadsorption (igeiaad)

Conditions: Atopic Dermatitis

Summary: removal of ige through adsorption of ige on a specially designed column after apheresis of blood has the potential to improve the severity of atopic dermatitis. in this study the investigators will treat patients with a severe form of atopic dermatitis not responding or having to much side effects to systemic imunosuppressive treatment with this modality.

patients will be treated with immunoadsorption on 4 consecutive days week 1 and three consecutive days week 5 and week 9. the clinical improvement and histological and serological tests will be evaluated.

Eligibility criteria:
inclusion criteria 1. adults (\> 18 year) with severe atopic dermatitis (objective scorad \> 40) 2. who's ad is persistent and stable since more than 1 year 3. who signed the informed consent 4. who are not pregnant or do not plan to become pregnant, during the immunoadsorption treatment 5. who were treated in the recent past with phototherapy or immunosuppressive therapy ( one or more : cyclosporin a, methotrexate , azathioprine , mycophenolate , systemic corticosteroids ) and where this therapy was not sufficiently helpful, had unacceptable side effects or are contraindicated exclusion criteria: 1. patients who did not give an informed consent. 2. patients with mild or moderate ad. 3. patients with severe ad improving with, and tolerating, standard therapy (including phototherapy, short periods of corticosteroids, the above mentioned immunosuppressive therapies ) and having no contra-indications for these therapies 4. pregnant women and female patients willing to become pregnant during the planned period of treatment or immediately after. 5. having contra-indications for immunoadsorption: * patients with a known allergy for the material used during immunoadsorption. * severe cardiovascular diseases. * severe bleeding during anticoagulation . * treated with ace-inhibitors. * patients younger than18 years. 6. having a malignant disease not under remission

Keywords: atopic dermatitis immunoadsorption