Kornimate/medical-research-clean huggingface dataset:
sensory motor interventions on preterm infants

Conditions: Preterm Infants

Summary: preterm infants experiencing bottle feeding difficulties will be included in this study. two distinct interventions, oral stimulation (os) and infant massage (im), will be administered in this study. the objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants.

currently, two rehabilitation approaches, prefeeding oral stimulation (os) and infant massage (im), are often used by health professionals to facilitate preterm infants' oral feeding abilities. the purpose of this study is to compare the effectiveness of prefeeding os and the combined approach of prefeeding os and im in improving feeding performance and development of preterm infants. participants will randomly allocated to two groups and receive either os or combined os plus im. prefeeding os is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes. im is a 15-minute intervention, including 5-min manual massage on the infant's head, neck, back, upper limbs, and lower limbs twice and 5-min passive exercise of moving the infant's arms and legs once. the os group will receive os twice a day for 10 days. the combined group will receive os once and im once a day for 10 days. both groups will undergo a bottle feeding assessment before, mid-term, and after the intervention period. neurodevelopmental assessments will be conducted before and after the intervention period. additionally, the investigator will conduct chart review to collect participants' birth and medical data. the primary outcomes are feeding performance parameters (e.g., the rate of milk transfer in the first 5 minutes of feeding, total oral intake volume, and milk leakage during bottle feeding) and neurodevelopment outcomes. secondary outcomes include weight gain and hospital stay. furthermore, a follow-up evaluation on feeding questionnaire at home and sensory processing function will be conducted when the infants reach three months of corrected age.

Eligibility criteria:
inclusion criteria: 1. \< 34 weeks' gestational age 2. 34\~40 weeks' postmenstrual age at enrollment 3. being fed by oral for at least 2 days but with poor feeding performance defined as consuming less than 80% of the prescribed volume for the half or more feedings 4. weaning the ventilator and maintaining stable physiological status exclusion criteria: 1. congenital anomalies 2. confirmed or suspected chromosomal or genetic abnormalities 3. unsolved seizure, sepsis, necrotizing enterocolitis(nec)

Keywords: nicu massage preterm infants oral stimulation
obstructive airways diseases in emergency department (oaded) study

Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Summary: this is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both chronic obstructive pulmonary disease (copd) and asthma patients.

this is a feasibility observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both copd and asthma patients. the study will include adults asthma and copd patients (age \>18) that arrive at the emergency department (ed). patients will be enrolled on a continuous basis and will be monitored by a capnograph and an oximeter before, during and after lung function assessment and medical treatment.

Eligibility criteria:
inclusion criteria: 1. age \>18 2. ability and willingness to participate the study and sign informed consent form 3. asthma / copd patients exclusion criteria: 1. pregnant women 2. asthma or copd patients with fev1 \> 60% 3. disability or unwillingness to undergo capnography measurement 4. cannot be assessed for fev1 5. oxygen supply \>5 l/min

Keywords: asthma copd capnography
efficacy of d-cycloserine for enhancing the effects of cbt for substance use

Conditions: Substance-Related Disorders

Summary: this study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence.

this is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of cbt.

Eligibility criteria:
inclusion criteria: the primary selection criteria include women and men between the ages of 18 and 65 who: 1. meet dsm-iv criteria for opiate dependence, 2. maintain a stable dose of methadone for two weeks prior to recruitment and: * fail to achieve "take-home" status for methadone dosing during at least the first four months of methadone treatment, * test positive on at least two toxicology screens for illicit drugs during the month prior to recruitment * have never achieved two consecutive toxicology screens free of illicit substances since entering the current treatment episode. 3. meet study criteria for chronic stress: * unemployment criteria, and * affective disorder criteria. exclusion criteria: 1. patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period). 2. patients with a psychotic or organic mental disorder according to dsm-iv criteria. 3. patients receiving medication affecting methadone metabolism (e.g. rifampin). 4. patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder). 5. patients unable to complete the informed consent or unable to understand study procedures in the informed consent process. 6. pregnancy or current alcohol use.

Keywords: cognitive-behavior therapy d-cycloserine cognitive enhancer drug dependence opiate dependence exposure isolated doses of d-cycloserine isolated doses of matching pill placebo dcs
imaging parameters to predict future vertebral fracture in osteoporosis

Conditions: Osteoporosis; Fracture

Summary: after vertebroplasty, many patients will suffer from 2nd fracture in the vertebral column. with analyzing of the images done right after the 1st vertebroplasty, we can define the parameters from different imaging and they can be predictors of the future fracture.

vertebroplasty is considered one of the alternatives for the treating of spine compression fracture associated with pain especially for those patients with osteoporosis. however, after vertebroplasty, the compliance of the bone becomes stronger than the adjacent vertebrae that is not treated. so there is always a consideration of future fracture of the adjacent vertebral bodies after vertebroplasty done on certain body. in this study, we try to follow the patients (5 years) to see if the adjacent vertebral bodies are prone to have fracture than the others away from the site of vertebroplasty.then we try to find out the image biomarkers to predict the future fracture in the vertebral bodies. the should be done with ct scan raw data, analysis with different algorithms. inclusion criteria; patients with osteoporosis and receiving vertebroplasty and with secondary fracture occurring in other spine exclusion criteria: no second vertebral body fracture occurred. primary measurement: the time and location of the 2nd fracture secondary measurement: the imaging biomarkers from ct scan.

Eligibility criteria:
inclusion criteria: * all the patients received vertebroplasty treatment between 2005.01-2011.12 with 2nd fracture in the vertebral column. exclusion criteria: * no image available

Keywords: fracture vertebral column osteoporosis predictor vertebroplasty
evaluation of safety and performance of intraoperative detection of light signals during electrosurgical breast cancer resection

Conditions: Breast Cancer; Resection Margin

Summary: this monocentric early feasibility first in human study is intended to evaluate safety and performance of intraoperative detection of light signals during electrosurgical breast cancer resection. in consequence the data should also be taken to adapt technical features according to the findings. the study results will be utilized to design and to calculate the sample size for future pivotal studies after finalizing this study and to adapt the technical features of the system and/ or device. in the future pivotal study, the effectiveness of method and the reduction in r1 resection rate will be assessed with the final goal to provide continuous or real-time information about the tissue type that is currently cut. the primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device. after signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. during the second visit (v2) they will receive the treatment procedure with the investigational medical device (imd). the follow up visit (v3) will be performed up to 7 days after the treatment procedure at the day of discharge from the hospital.


Eligibility criteria:
inclusion criteria: 1. female patient with primary invasive breast cancer (nst or nst with dcis component, including endocrine pretreatment according to standard of care therapy at the study site) 2. solid tumor size ≥ 15 mm at screening, on sonography imaging 3. breast conserving surgery 4. ≥ 18 years of age 5. ability to provide written informed consent exclusion criteria: 1. neoadjuvant chemotherapy 2. bilateral breast conserving surgery 3. invasive lobular carcinoma, dcis, lcis 4. suspicion of extensive dcis component of nst tumor 5. diagnosis of recurrent breast cancer 6. previous radiotherapy 7. patient is pregnant or lactating 8. patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant), passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator 9. according to physicians' assessment, patient is not able to follow study protocol (e.g., due to cognitive disease) or is not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation
a study of trastuzumab-mcc-dm1 administered intravenously to patients with her2-positive metastatic breast cancer who have previously received a trastuzumab-containing regimen

Conditions: Metastatic Breast Cancer

Summary: this is a phase i, multicenter, open-label, dose-escalation study of single-agent trastuzumab-mcc-dm1 administered by intravenous (iv) infusion in patients with her2-positive metastatic breast cancer (mbc) who have previously received trastuzumab. the study will assess the safety, tolerability, and pharmacokinetics of trastuzumab-mcc-dm1 and determine the dose and schedule to be used in phase ii.


Eligibility criteria:
inclusion criteria: * histologically documented, incurable, locally advanced or metastatic breast cancer * evaluable or measurable her2-positive disease * history of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for her2-positive breast cancer * previous treatment with chemotherapy for mbc * granulocyte count ≥ 1,500/μl, platelet count ≥ 100,000/μl, and hemoglobin ≥ 9 g/dl * serum bilirubin ≤ 1.5 mg/dl; ast, alt, and alkaline phosphatase ≤ 2.5 × upper limit of normal (uln) except for: patients with hepatic metastases: alt and ast ≤ 5 × uln patients with hepatic and/or bone metastases: alkaline phosphatase ≤ 5 × uln * serum creatinine ≤ 1.5 mg/dl or creatinine clearance of ≥ 60 ml/min based on a 24-hour urine collection * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * women of childbearing potential and men must agree to use an effective method of birth control (e.g., hormonal, barrier) while receiving study treatment exclusion criteria: * history of significant cardiac disease, unstable angina, chf, myocardial infarction, or ventricular arrhythmia requiring medication * history of grade ≥ 3 hypersensitivity reaction to trastuzumab * history of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued * symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment * require supplemental oxygen for daily activities * grade ≥ 2 peripheral neuropathy * bisphosphonate therapy for symptomatic hypercalcemia * any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment * any experimental therapy within 4 weeks of first study treatment * any major surgical procedure within 4 weeks of first study treatment * history of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis * pregnancy or lactation * cardiac troponin i ≥ 0.2 ng/ml * ejection fraction \< 50% or below the lower limit of normal determined by echocardiogram or muga scan * prior cumulative doxorubicin dose of \> 360 mg/m2 or equivalent

Keywords: her2-positive breast cancer mbc trastuzumab emtansine herceptin t-dm1
rdri and ngal in acute kidney injury in abdominal surgery

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki), which can occur after major surgeries, leads to increased morbidity and mortality if not detected and managed promptly. in clinical practice, serum creatinine and urine output values of patients are monitored to detect aki, but these parameters can cause delays in diagnosis. additionally, studies have been conducted on biomarkers such as neutrophil gelatinase-associated lipocalin (ngal) and cystatin c in recent years, but definitive results have not been achieved. renal doppler resistive index (rdri) is a non-invasive index believed to reflect renal vascular perfusion. rdri measurement is a repeatable, inexpensive, and easy-to-apply technique. rdri has been found to be associated with aki in conditions such as renal dysfunction, hypertension, and post-traumatic hemorrhagic shock. furthermore, due to the impact on renal perfusion in patients undergoing major surgery, rdri, which reflects renal vascular resistance, can serve as an indicator of kidney perfusion. the aim of this study is to test the hypothesis, 'does measuring postoperative rdri in major abdominal surgery cases yield higher sensitivity and specificity values in detecting acute kidney injury compared to ngal?'


Eligibility criteria:
inclusion criteria: * asa i-iii, * patients undergoing elective major abdominal surgery exclusion criteria: * chronic kidney failure, * using nephrotoxic drugs, * patients with a history of kidney transplantation or nephrectomy

Keywords: acute kidney injury neutrophil gelatinase-associated lipocalin renal doppler resistive index major abdominal surgery
effect of transcutaneous electrical stimulation on post-stroke dysphagic patients

Conditions: Dysphagia

Summary: oropharyngeal dysphagia (od, swallowing dysfunction) is a major complaint following stroke. despite its enormous impact on functional capacity, quality of life, and survival, od is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. a recent systematic review on the effects of rehabilitation therapy on od concluded that although some positive effects were found, the number of studies was small, many of them had methodological problems and there was a need for further research using randomized controlled trials. transcutaneous electrical stimulation was approved by the fda as a treatment of dysphagia in june 2001 and is traditionally used to activate pharyngeal muscles through stimulation of peripheral motor nerves (neuromuscular electrical estimulation, nmes). however, their real effectiveness and safety in the treatment of dysphagia is still matter of discussion (logemann dysphagia 2007, ludlow dysphagia 2007) and studies evaluating nmes therapy, present discordant results. on the other hand, in recent years, transcutaneous electrical stimulation is beginning to use as a sensory strategy (gallas 2010), avoiding muscle contraction during the treatment.our research strategy includes the assessment of the therapeutic effect of these two main strategies using transcutaneous electrical stimulation on swallow physiology and clinical outcomes of post-stroke dysphagic patients.


Eligibility criteria:
inclusion criteria: * age \> 18 * background of swallowing difficulties associated with stroke, more than 3 months of evolution * study explained and signed informed consent exclusion criteria: * patients who are suspected or can not meet the protocol. patients who are participating or have participated in a trial last 4 weeks. patients with active cancer patients with active infectious process. patients with severe dementia or inability to communicate. patients with neurodegenerative diseases. patients with pacemakers. patients with implanted electrodes. patients with epilepsy or seizure disorders. patients with gastroesophageal reflux.

Keywords: oropharyngeal dysphagia post-stroke
oxy-2: the pharmacogenetics of oxycodone analgesia in human experimental pain models

Conditions: Healthy

Summary: thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days receive oxycodone 20 mg po vs. placebo. half of the volunteers will be poor metabolizers according to cyp2d6 genotype and half will be extensive metabolizers (em) and have an enzyme with normal function. the study hypothesis is that pm will experience less pain relief than em.

oxycodone is a semi-synthetic opioid with an analgesic effect in the postoperative pain management comparable to morphine. oxycodone is n-demethylated by cyp2d6 to its active metabolite oxymorphone, a potent μ-receptor agonist. a genetic polymorphism divides a caucasian population into two groups: 8% with an enzyme lacking activity, poor metabolizers (pm) and the rest with normal cyp2d6 activity, extensive metabolizers (em). many different, single nucleotide polymorphisms (snps) are responsible for interindividual differences in the effect of opioids. among these are the a118g snp in the μ-receptor gene oprm1 and the c3435t and g2677t/a snps in the mdr-1 gene of p-glycoprotein. p-glycoprotein is responsible for the absorption, excretion and transport of many drugs including opioids over the blood-brain barrier. electrical stimulation and cold pressor test are among the most well defined and evaluated human experimental pain models. the 32 volunteers will be submitted to the tests before and 1, 2, 3 and 4 hours after medicine intake. to determine the plasma levels of oxycodone and its metabolites blood will be drawn after each pain test. also the cyp2d6 genotype and the above mentioned snps will be determined from the blood samples.

Eligibility criteria:
inclusion criteria: * healthy volunteer age between 20 and 40 years. * healthy according to medical history and physical examination. * informed consent given. * phenotyped or genotyped as extensive or poor metabolizer of sparteine. * female: use of safe contraception (iud, gestagen injectiones or oral contraceptive) or negative u-hcg test. exclusion criteria: * any known allergy or intolerance to oxycodone. * regularly drug therapy or medication (except contraceptives). * alcohol or medicine abuse.
correlation of calcitonin gene-related peptide (cgrp) levels in saliva with the evolution of an attack of migraine

Conditions: Headache, Migraine

Summary: to assess cgrp levels in saliva through the evolution of migraine.

the release of cgrp is assumed to be initiated early in the migraine process and increases as the headache intensifies. levels of cgrp will be measured during the premonitory, mild, moderate, and severe phases of a single migraine attack and compared to the baseline value determined when the subject was headache free. understanding of the clinical evolution of migraine cgrp release may have significant implications in acute treatment.

Eligibility criteria:
inclusion criteria: 1. ability to read, understand, and sign the informed consent 2. subject is between the ages of 18 and 65, either male or female 3. negative pregnancy test for those of childbearing potential. 4. adequate birth control as approved by the investigator if of childbearing potential 5. subjects must fulfill criteria for ihs migraine (1.1 or 1.2) with a history of 1-6 migraines per month within the past 3 months and at least 15 headache free days though out the previous three month time period exclusion criteria: 1. pregnant or breast feeding 2. presence of any condition or symptoms that would knowingly alter the content of the saliva 3. presence of any medical disease or condition that would interfere with the conduct of the study 4. current use of other medications that would be contraindicated in those patients that will take triptan medications for treatment of migraine symptoms, ie. mao inhibitors, lithium, methyergonovine, methysergide, or ergotamine-containing products 5. use of migraine preventive medications in the three months prior to screening 6. history of drug or alcohol abuse that would interfere with the study 7. any pathology of the salivary glands such as sialadenitis (e.g., sjorgen's syndrome, viral or bacterial sialadenitis, obstructive sialadentitis) 8. history of hypersensitivity or allergy to triptan medications 9. presence of diabetes, salivary gland tumors, liver disease, alcoholism, and neuropathy 10. more than 15 days per month of headache within the past 3 months 11. participation in another investigative drug study within the past 30 days