Kornimate/medical-research-clean huggingface dataset:
safety of fluconazole treatment of premature and full-term newborn infants

Conditions: Ductus Arteriosis, Patent; Bacterial Infections and Mycoses

Summary: this study will investigate pharmacological interventions between fluconazole and ibuprofen when they are given to premature newborn babys. this in order to find out if the drugs are influencing each other when they are given at the same time. the study is meant to find out if there are reasons to adjust the dose when fluconazole and ibuprofen are given together.

to evaluate the effect of fluconazole and/or ibuprofen on the urinary excretion of two vasoactive arachidonic acid products, thromboxane a2 (txa2) and prostacycline (pgi2), in newborn infants treated with one or both of these drugs because of fungal infection prophylaxis and/or patent ductus arteriosis (pda), respectively, as measurement of the possible interactions between these drugs.

Eligibility criteria:
inclusion criteria: 1. newborn infants in need of prophylaxis with fluconazole according to clinical routines and/or clinical indication for treatment of patent ductus arteriosis (pda), or newborn infants who are not treated with either fluconazole or ibuprofen according to the following study groups: 1.1 premature newborn infants with gestational age 23+0 to 26+6 weeks who are treated only with fluconazole. 1.2 premature newborn infants with gestational age 23+0 to 26+6 weeks who are treated with both fluconazole and ibuprofen. 1.3 premature newborn infants with gestational age 27+0 to 36+6 who are treated only with ibuprofen. 1.4 premature newborn infants with gestational age 27+0 to 36+6 and fullterm infants who are not treated either with fluconazole or ibuprofen. 2. parents that are in command of the swedish language and capable of understanding the study plan 3. informed written parental consent exclusion criteria: 1. infants who need treatment with other drugs that are metabolised by enzyme cytochrome (cyp2c9) (such as phenytoin, sulphamethoxazole, fluvastatin, sildenafil, losartan, irbesartan, torsemide, tienilic acid), or any other enzyme involved in the metabolism of fluconazole and or nsaids, or treatment with drugs that interact with nsaids at the cyclooxygenase level, or interact with the vasal effects of the metabolic products of the cyclooxygenase. 2. infants without possibility to conceive the objectives and implications of the study in the opinion of the investigator.
stereotactic body radiotherapy for prostate cancer

Conditions: Prostate Cancer

Summary: this study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (sbrt) for the treatment of organ confined prostate cancer.

this is a single site, non-randomized, prospective, phase iv trial of patients with organ-confined prostate cancer. data collected will include patient demographics, pathology data, tumor stage, sbrt dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. follow up data will be collected during the patient's standard office visits. the anticipated duration of this study is 5 years.

Eligibility criteria:
inclusion criteria: * patient age \>= 18 years * zubrod performance status of 0-3 * t1-3 n0 m0 adenocarcinoma of the prostate * prostate volume ≤ 100 cc * signed study-specific consent form exclusion criteria * extension of local tumor to involve adjacent organs other than seminal vesicles (t4) * prostate volume \> 100 cc * nodal involvement * metastatic disease * prior pelvic radiotherapy except as part of combination therapy for prostate cancer * history of scleroderma * patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Keywords: prostate cancer stereotactic radiotherapy
effect of an anti-inflammatory drug on gut mucosa in hiv infected patients

Conditions: HIV Infections

Summary: the lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of the immune system. like other parts of the immune system, hiv attacks this lymphoid tissue. this study will evaluate the effect of an anti-inflammatory drug on the lymphoid tissue in the gastrointestinal tracts of people with hiv.

the gastrointestinal tract is the body's largest lymphoid organ. because it contains significant numbers of activated memory t lymphocytes, it is a prime site for hiv infection and amplification. mucosal t cells are extremely vulnerable to hiv infection due, in part, to a marked increase in ccr5 co-receptors. understanding the impact of hiv on the gastrointestinal-associated lymphoid tissue (galt) is essential and may provide insight into the profound drop in mucosal lymphocytes during early infection, persistence of tissue viral replication in the setting of undetectable plasma viral activity, and compartmentalization of hiv. pre-clinical studies have demonstrated that the mucosal compartment in hiv uninfected individuals is characterized by features which enhance vulnerability to hiv infection compared to blood. once infected, the mucosal response to hiv is inflammation. this study will further evaluate the inflammatory response of mucosal tissue to hiv by examining the effect of the anti-inflammatory drug 5-aminosalicylic acid (5-asa) on the gut mucosa. participants in this study will be randomly assigned to receive either 5-asa or placebo. participants will be enrolled in the study for 8 weeks; participants may then elect to continue on 5-asa for an additional 16 weeks. participants will have four screening visits in the month prior to beginning the study and four study visits during the 8-week study. assessments will include medical interviews and physical exams, sigmoidoscopy with mucosal biopsy, and blood tests.

Eligibility criteria:
inclusion criteria * hiv infected * stable plasma viral load between 500 and 100,000 copies/ml for 3 months prior to study entry * stable antiretroviral therapy for at least 3 months prior to study entry * cd4 cell count greater than or equal to 200 cells/mm3 * mucosal viral rna greater than or equal to 100 copies/microg total rna within 2 weeks of study entry exclusion criteria * allergy or intolerance to salicylates * gastrointestinal tract infection causing diarrhea or colonic inflammation * renal or hepatic disease * current opportunistic infection * history of extensive small bowel resection (greater than 1/2 the length of the small intestine) * history of intestinal mucosal disease (except hiv) * chronic, regular use of aspirin and/or anti-inflammatory agents within 7 weeks prior to study entry * oral, topical, or rectal steroids or 5-asa within 3 months prior to study entry * certain laboratory abnormalities * significant neuropsychiatric symptoms that in the opinion of the study official could impact the conduct or outcome of the study

Keywords: mucosa inflammation tissue viral load anti-inflammatory hiv-related diarrhea mucosal inflammation treatment experienced
study of anginera in adults with a left ventricular assist device (lvad) as bridge to transplant

Conditions: Heart Failure

Summary: the purpose of this study is to obtain human heart tissue after treatment with anginera to determine its effect on a variety of things that might indicate improvement in heart function. patients who will have a left ventricular assist device (lvad) implanted while they wait for a donated heart will be treated with anginera. at the time of heart transplant, their diseased heart which is removed will be analyzed by microscopic examination to see what effect anginera had.

this will be a prospective, multi-center, randomized, open-label, within-patient paired design study. the primary purpose is to analyze cardiac tissue obtained after application of anginera to adults with an lvad as a bridge to transplant, to determine effects on various markers.

Eligibility criteria:
inclusion criteria: * stage d heart failure * patients having an lvad implanted as a bridge to transplant. exclusion criteria: * biopsy proven acute myocarditis * known giant cell myocarditis * known infiltrative disease, e.g. cardiac amyloidosis, sarcoidosis, hemochromatosis, fabry's disease

Keywords: anginera lvad transplant histology lvad implantation as a bridge to transplant
sucrosomal iron supplementation in blood donors

Conditions: Iron-deficiency

Summary: the aim of this descriptive/explorative pilot study is to examine the effects of supplementing a sucrosomal iron preparation in whole blood donors with iron deficiency for three months.

in this academic, monocentric interventional pilot study with one cohorte, otherwise healthy blood donors who have been rejected from blood donation due to low hemoglobin (females \<12.5 g/dl, males \<13.5 g/dl) and low ferritin levels (\<30 ng/ml) receive an iron-containing dietary supplement (sucrosomal iron) for three months with a daily intake of 30 g iron. fifty donors will be included in the study. the study population will consist of two sub-groups (premenopausal women and postmenopausal women plus men). our aim is to * gain first findings concerning the extent of the change primarily in hemoglobin and secondly in ferritin concentrations * observe acceptance and tolerance after intake of the test product for several months * create pilot data for a following randomized controlled study. in addition, possible clinical symptoms associated with iron deficiency will be recorded by using appropriate questionnaires (questionnaire on the assessment of health-related quality of life \[whoqol-bref\], fatigue questionnaire \[faq\], questionnaire on psychic symptoms of insomnia \[ris\] and restless legs syndrome).

Eligibility criteria:
inclusion criteria: * deferral from donation because of low capillary hemoglobin (hb) \<12.5 g/dl (women) and hb \<13 g/dl; * otherwise eligibility for donation according to medical history; * ferritin at the time of deferral \<30 ng/ml; * last whole blood donation \>2 months prior to current hemoglobin level; * written informed consent; * venous hb \<12.5 g/dl (females) and \<13.5 g/dl (men); exclusion criteria: * lack of legal capacity or court-appointed representation; * known pregnancy; * lactation period; * chronic diarrhea or known inclination for diarrhea; * known or suspected fructose intolerance; * iron supplementation during the last three months; * continuous or expected blood loss (capillary oozing); * hypermenorrhea; * planned surgical intervention with relevant blood loss within the next 3-4 months (duration of study); * application of another iron supplementation during the next 3-4 months; * intended application of preparations for a systematic increase of red blood cell and hemoglobin concentration or production (e.g. erythropoietin preparations, packed red blood cells) for the duration of the study; * parallel participation in another clinical trial with insurance coverage; * foreseeable compliance issues; * foreseeable unavailability for the time of the final examination; * incompatibility with any of the ingredients of the product; * anemia requiring acute therapy: hb \<8g/dl (as indication of an obligatory correction of the hemoglobin level to a clinically irrelevant or non-therapeutic value);

Keywords: blood donors donor rejection sucrosomal iron dietary supplements
prospective cohort study on the safety and efficacy of endorobotics for endoscopic submucosal dissection (endorobotics esd)

Conditions: Gastrointestinal Neoplasm

Summary: this trial is a prospective, single arm study of 30 patients recruited to undergo endoscopic submucosal dissection (esd) with a novel robotic assisted technology. it will assess the safety and performance of robotic-assisted endoscopic submucosal dissection (esd) of superficial gastric and colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques. the primary outcome of the study is rate of complete (r0) resection of the neoplasia.


Eligibility criteria:
inclusion criteria: * patients with endoscopic diagnosis of early gastric or colorectal neoplasia * patients will be recruited according to esge and jges guidelines for gastric \& colorectal esd including: 1. lesions for which en bloc resection with snare emr is difficult to apply; 2. mucosal tumors with submucosal fibrosis; 3. sporadic tumors in conditions of chronic inflammation and 4. local residual or recurrent early carcinomas after endoscopic resection. exclusion criteria: * informed consent not available * carcinoma of colon or rectum or stomach with invasion to submucosa or beyond * evidence of distant metastasis * presence of another active malignancy * pregnancy * patients unfit for general anesthesia * endoscopic platform cannot reach target lesion * patients recruited into another clinical trial.

Keywords: endoscopic submucosal dissection
efficacy and safety of lenalidomide as a treatment for recurrent or refractory poems syndrome trial

Conditions: POEMS Syndrome

Summary: this study investigates the efficacy and safety of lenalidomide as a treatment for recurrent or refractory poems (crow-fukase) syndrome.

this study investigates the efficacy and safety of lenalidomide as a treatment for recurrent /refractory poems (crow-fukase) syndrome.

Eligibility criteria:
inclusion criteria: 1. patients with crow-fukase syndrome (confirmed by diagnostic criteria.) 2. recurrent or refractory crow-fukase syndrome. 3. patients without severe liver or renal dysfunction. 4. patients without severe neutropenia or thrombocytopenia. 5. patients without clinically problematic ecg findings 6. negative on the pregnacy test on the day 1 of cycle 1. 7. patients who can undertake prevention of pregnancy, if necessary. 8. patients with written informed consent. 9. patients who are capable of ambulatory hospital visits every 4 weeks. 10. patients with informed consent to the registration and rules of revmate®. exclusion criteria: 1. patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration. 2. patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration. 3. patients who have been administered bevacizumab within 12 weeks prior to the registration. 4. patients who could worsen acutely during the clinical trial period. 5. patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes. 6. patients with malignancies. 7. female patients who are pregnant or desire childbearing. males who desire fertility. 8. patients who allergic to lenalidomide or dexamethasone.

Keywords: poems syndrome lenalidomide
18 month follow up of preterm infants enrolled in the cord clamping study

Conditions: Developmental Delay

Summary: the purpose of this study is to examine differences in the long-term effects of immediate versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22 months corrected age.

the current obstetrical practice at birth in the united states is that the umbilical cord of the very low birth weight (vlbw) infant is clamped immediately. when immediate cord clamping occurs, up to 50% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia (low blood volume). in the investigators previous randomized control trial, it was found that infants who received a simple delay in umbilical cord clamping for 30-45 seconds experienced significantly lower incidence of bleeding in the brain and fewer systemic infections throughout the neonatal intensive care unit (nicu) stay and had higher scores on muscular control and function at 7 months corrected age. in the investigators current phase 2 randomized controlled trial, examines the motor functioning of infants randomized to immediate cord clamping (icc) or delayed cord clamping (dcc) at 7 months corrected age (age based on due date and not the pre-term birth rate). our objective for this new grant from the thrasher foundation is to examine the differences in the long-term effects of icc vs. dcc on developmental outcomes of our study infants at 18-22 months corrected age. the investigators hypothesis is that the positive effects of dcc, less bleeding in the brain and less infection, may also result in better motor and mental functioning at 18-22 months corrected age. differentiation between cognitive and motor function is more obvious in the developing toddler than in younger infants. the diagnosis of cerebral palsy becomes more definitive with age and cognitive skills such as expressive and receptive language continue to emerge.

Eligibility criteria:
inclusion criteria: * pregnancy between 24 and 31.6 weeks * singleton fetus * threatened preterm birth. exclusion criteria: * fetuses: congenital anomalies * mothers: severe or multiple maternal illnesses * drug users or institutionalized or psychotic women

Keywords: delayed cord clamping developmental delay
urinary and sexual function before and after surgical decompression of cervical myelopathy

Conditions: Myelopathy; Neurogenic Bladder; Erectile Dysfunction; Psychosexual Dysfunctions; Sexual Arousal Disorder

Summary: hypotheses: decompressive surgery of cervical myelopathy will improve bladder function. decompressive surgery of cervical myelopathy will improve sexual function.

the investigators will enroll consecutive cohort with cervical myelopathy who are scheduled to take surgical decompression of cervical spinal cord, aged between 25 and 65. the exams for the patients include followings * joa (japanese orthopaedic association) scores for cervical myelopathy * vas (visual analog scale) pain score * ipss (international prostate symptom score) and iief (international index of erectile function) in male patients * fsfi (female sexual function index) and udi (urinary distress inventory) in female patients * bladder compliance, detrusor leak point pressure, peak detrusor pressure * rigidity activity unit of penis

Eligibility criteria:
inclusion criteria: * evidence of progression of motor or sensory nerve * cervical myelopathy in magnetic resonance imaging exclusion criteria: * radical pelvic surgery * pelvic irradiation * evidence of brain damage (dementia, cerebrovascular disease) * evidence of psychotic disorder

Keywords: myelopathy
randomized trial of vaginal self sampling for human papillomavirus (hpv)

Conditions: Human Papillomavirus Infection; Cervical Intraepithelial Neoplasia

Summary: up to 30% of canadian women do not participate in pap smear screening for cervical cancer prevention despite many being members of family practices and having access to family physicians. one reason is reluctance to undergo pelvic examination. the investigators purpose is to determine whether the offer of vaginal self sample collection for oncogenic human papillomavirus (hpv) testing increases participation in cervical cancer screening compared to repeat reminder for pap smear testing among female family practice members who have not previously responded to invitations for pap testing.

pap smear screening for cervical cancer precursors has substantially reduced the incidence of invasive cervical cancer in canada. while regular pap screening can give up to 90% protection against cervical cancer, about 30% of canadian women do not participate in regular screening. pap screening in ontario is opportunistic. there are women who have family doctors and regularly present for other medical issues at their physician's office but forego pap smear testing. numerous studies have shown that women are able to self collect vaginal samples, and that these samples can be tested for the presence of oncogenic human papillomavirus. a recent meta-analysis showed that hpv testing through physician collected samples had a sensitivity of 80%-90% for detection of cervical intraepithelial neoplasia (cin) 2 or worse, and a specificity of 86%-95%. in comparison, a meta-analysis of self collected vaginal samples tested for hpv showed a sensitivity of 74% and a specificity of 88%. studies have reported that women find self collection acceptable. however, we have found that many women are more comfortable if a health care professional is available to help if needed, and so this option should be provided for self-testing. we are proposing a randomized controlled trial to see whether (a) the offer of a vaginal self collection kit together with a second reminder for pap testing will increase cervical screening participation amongst "never-screened" and "hard to reach" women, as compared to (b) a second reminder letter alone.

Eligibility criteria:
inclusion criteria: * members of consenting family physicians identified through oscar emr * overdue for pap smear testing * have not presented for pap smear screening after 1 reminder letter exclusion criteria: * currently attending colposcopy clinic * institutionalized * without a cervix

Keywords: vaginal self collection human papillomavirus (hpv) cervical intraepithelial neoplasia
the impact of gastrostomy and intermittent oral tube feeding on patients with dysphagia and bulbar palsy after stroke

Conditions: Dysphagia

Summary: the goal of this clinical trial is to compare the differences in quality of life and nutritional status between ischemic stroke patients with dysphagia and bulbar palsy using intermittent oro-esophageal tube and gastrostomy. patients will be randomly divided into an oral tube group and a gastrostomy group, all receiving routine rehabilitation treatment. on this basis, the oral tube group will use intermittent oro esophageal tube for enteral nutrition support, while the gastrostomy group will use gastrostomy. researchers will compare changes in quality of life and nutritional status of two groups of patients before and after the study to see if intermittent oro-esophageal tube can improve the quality of life and nutritional status between ischemic stroke patients compared gastrostomy.

this study lasts 15 days for each patient. the goal of this clinical trial is to compare the differences in quality of life and nutritional status between ischemic stroke patients with dysphagia and bulbar palsy using intermittent oro-esophageal tube and gastrostomy. patients will be randomly divided into an oral tube group and a gastrostomy group, all receiving routine rehabilitation treatment. on this basis, the oral tube group will use intermittent oro esophageal tube for enteral nutrition support, while the gastrostomy group will use gastrostomy. researchers will compare changes in quality of life and nutritional status of two groups of patients before and after the study to see if intermittent oro-esophageal tube can improve the quality of life and nutritional status between ischemic stroke patients compared gastrostomy.

Eligibility criteria:
inclusion criteria: * age\>18 years. * meeting the diagnostic criteria for ischemic stroke . * dysphagia confirmed by videofluoroscopic swallowing study. * clear consciousness. * no history of prior stroke. * stable vital signs. exclusion criteria: * dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc. * complicated with severe liver and kidney failure, tumors, or hematological disorders. * simultaneously in need to undergo other therapy that might affect the outcomes of this study. * pregnant or nursing females.