Kornimate/medical-research-clean huggingface dataset:
proton beam therapy for treatment of hepatocellular carcinoma

Conditions: Liver Cancer; Hepatocellular Carcinoma

Summary: this study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.

hepatocellular carcinoma (hcc) is a type of primary cancer of the liver that is being diagnosed in the u.s. population with increasing frequency. while surgery is the first line of treatment, many patients are not eligible for surgical removal. current non-surgical treatments for hcc are not fully effective and can have substantial side-effects. this study utilizes a type of radiation treatment called proton beam that can deliver high doses of radiotherapy to tumors within the liver while minimizing damage to surrounding healthy tissues. the treatment is non-invasive and is given on an out-patient basis over a three week coarse. the study will evaluate the effectiveness and side-effects of this therapy by tracking patient's outcomes following treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of hepatocellular carcinoma * adult patients aged 18 years old and above * ability to give informed consent for study * compensated liver disease exclusion criteria: * pediatric patients (aged less than 18 years old) * decompensated or advanced liver disease * poorly controlled ascites * variceal hemorrhage within the previous 30 days * recurrent hepatic encephalopathy * cirrhosis with ctp\* score \>10 * active alcohol or drug abuse * anticipated survival of less than 30 days * advanced co-morbid medical illnesses * karnofsky performance score \<60 tumor characteristics: - any tumor that can not be safely and effectively irradiated due to inability to deliver target treatment dose to required treatment volume or due to prohibitively high risk of anticipated toxicities to normal liver or nearby bowel, stomach, kidney or spinal cord.

Keywords: proton radiotherapy hepatocellular carcinoma liver cancer
effects of probiotic and prebiotic combinations on premature infants

Conditions: Premature Infants; Stool Bacterial Composition; Growth

Summary: the purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants. our hypothesis is that short term growth will be improved, the stool will have more healthy bacteria, and the fecal short chain fatty acid content will increase in the babies who receive the probiotic/prebiotic combinations compared to control groups.

premature infants are at risk for a devastating infection of the intestines due to the immaturity of their intestines and immune system. probiotics are bacteria with healthful qualities that are taken by mouth to improve the number of healthy bacteria in the intestines. probiotics have been shown in several studies outside the u.s. to decrease the risk of serious intestinal infection and in one small study to improve the rate of weight gain in premature infants. prebiotics are food supplements that stimulate the growth of healthy bacteria and suppress the growth of unhealthy bacteria. prebiotics have been shown to improve the numbers of healthy bacteria in the stool of premature babies. our study is designed to compare two over the counter probiotic/prebiotic combinations to each other and to a control group. infants less than 35 weeks with a birthweight of 750-2000 gm are eligible and must be enrolled in the study within the first week of life. the babies are randomly assigned to either a control group (no probiotic/prebiotic, just a placebo), a group which receives culturelle (lactobacillus rhamnosus gg plus fructo-oligosaccharide, conagra), or a group which receives probioplus (three strains of bifidobacteria plus lactobacillus acidophilus plus fructo-oligosaccharide, uas laboratories). the babies receive the study product by mouth twice daily for 28 days or until discharge (whichever comes first). weekly measurements (weight, length, head size) and stool cultures are performed. clinical progress is closely monitored and any episodes of infection are recorded.

Eligibility criteria:
inclusion criteria: * less than 35 weeks gestation, birth weight 750-2000 grams * born in or transferred to university of california davis medical center within first week of life * less than eight days of age at the time of enrollment exclusion criteria: * severe intestinal or cardiac congenital anomalies

Keywords: probiotic prebiotic nec premature infants commensal flora
study of individualized, precise and standardized cervical open-door surgery for cervical spinal stenosis

Conditions: Cervical Spinal Stenosis; Cervical Spinal Cord Injury; Individuation; Standardization

Summary: to evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis.


Eligibility criteria:
inclusion criteria: * the age of 28-85 years old; through systematic clinical and imaging examination, patients diagnosed with c3-7 multilevel cervical spondylitis myelopathy or cervical spinal stenosis who need to undergo posterior cervical open-door surgery. * no contraindications in preoperative routine tests and examinations. * informed consent of patients. exclusion criteria: * cervical radiculopathy * cervical kyphosis or instability * cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases * revision surgery or combined anterior-posterior surgery is required * serious neurological diseases affect the postoperative effect evaluation * mental illness cannot cooperate with follow-up * contraindications for mri examination * patients themselves or their families do not agree to participate in the study * other situations that are not suitable for study participation.

Keywords: cervical spinal stenosis open angle
attempted suicide with acetaminophen among 8-18 year-old children / adolescents in denmark

Conditions: Hepatic Injury

Summary: a: early predictors of hepatic injury after suicide attempt with acetaminophen: to explore the following in a pediatric population with acetaminophen overdose due to suicide attempt: 1) the prevalence of episodes of pre- and in-hospital vomiting and the relationship between the total number of vomiting episodes and hepatic injury, 2) the relevance of the early initiation of n-acetylcysteine (nac) treatment to hepatic injury, and 3) the presence/absence of illness prior to the suicide attempt and hepatic injury. b: characteristics, social behaviour, trends and risk factors: 1. to explore the relationship between children admitted to a paediatric department as a result of suicide attempts with acetaminophen and their parents and friends. 2. to determine the extent to which the children had attempted to speak to their parents or other adults about their problems before their suicide attempts. 3. to determine the prevalence of self-mutilation among children with suicidal behaviour. 4. to examine the reasons for these suicide attempts. c: establishment of the expression of cytochrome p450 in a pediatric including the age-adjusted activities. urine samples will be analyzed using an hplc tandem mass spectrometric method, which we have already established in our lab. there will be categorized three groups for comparison: 1. an age-appropriate background population (approximately 200 patients) 2. paediatric patients that have been admitted to rigshospitalet, due to severe hepatic injury (approximately 50 patients) 3. other pediatric patients admitted to their local hospital because of acetaminophen poisoning (approximately 200 patients) a control urine sample will be analyzed three months after the suicide attempt.


Eligibility criteria:
inclusion criteria: * 8-18 years-old, who tried to commit suicide with acetaminophen. * children are only included if they have answered all our standard questions. exclusion criteria: * children with known liver disease prior to the suicide attempt. * if a child have several suicide attempts during the inclusion-period, only the 1st will be included. * suicide attempts with other agents than acetaminophen. * children taking medication that enhance the induction of the cytochrome p450 system, increase the production of toxic metabolites, and aggravate the hepatic injury, such as ethanol, rifampin, isoniazid, barbiturates, and carbamazepine, will be excluded.

Keywords: acetaminophen suicide attempts early predictors of hepatic injury childhood suicidal behaviour
reveal 1 (evaluation of vgx-3100 and electroporation for the treatment of cervical hsil)

Conditions: Cervical Dysplasia; Cervical High Grade Squamous Intraepithelial Lesion; HSIL

Summary: hpv-301 is a prospective, randomized, double-blind, placebo controlled phase 3 study to determine the efficacy, safety, and tolerability of vgx-3100 administered by intramuscular (im) injection followed by electroporation (ep) delivered with cellectra™ 5psp in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (hsil) (cervical intraepithelial neoplasia grade 2 \[cin2\] or grade 3 \[cin3\]) associated with human papillomavirus (hpv) 16 and/or hpv-18.


Eligibility criteria:
inclusion criteria: * women aged 18 years and above * confirmed cervical infection with hpv types 16 and/or 18 at screening * cervical tissue specimen/slides provided to study pathology adjudication committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug * confirmed histologic evidence of cervical hsil at screening * must be judged by investigator to be an appropriate candidate for the protocol-specified procedure required at week 36 * with respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with failure rate of less than 1% per year when used consistently and correctly from screening until week 36 * normal screening electrocardiogram (ecg) exclusion criteria: * microscopic or gross evidence of adenocarcinoma-in-situ (ais), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening * cervical lesion(s) that cannot be fully visualized on colposcopy * history of endocervical curettage (ecc) which showed cervical hsil indeterminate, or insufficient for diagnosis * treatment for cervical hsil within 4 weeks prior to screening * pregnant, breastfeeding or considering becoming pregnant during the study * history of previous therapeutic hpv vaccination * immunosuppression as a result of underlying illness or treatment * receipt of any non-study, non-live vaccine within 2 weeks of day 0 * receipt of any non-study, live vaccine within 4 weeks of day 0 * current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results * presence of acute or chronic bleeding or clotting disorder that would contraindicate im injections, or use of blood thinners within 2 weeks of day 0 * participation in an interventional study with an investigational compound or device within 30 days of signing informed consent * less than two acceptable sites available for im injection

Keywords: cervical intraepithelial neoplasia (cin) human papillomavirus (hpv) high grade squamous intraepithelial lesion (hsil) cin 2 cin 3 papillomavirus
evaluation of a novel electronic urine output monitor (euom)

Conditions: Oliguria; Polyuria

Summary: urine output and urine drain line pressure were monitored while urine was drained into either: 1. accuryn urine output monitor (potrero medical) or 2. criticore monitor (bard medical)

the purpose of this study is to determine the characteristics of urine output and drain line pressure as measured with the accuryn urinary output monitoring system and urine output as recorded by a commercially available system (criticore, bard medical) when used with a standard foley catheter and standard urinary drainage tube.

Eligibility criteria:
inclusion criteria: * patient must ≥ 18 years of age * patient has a foley catheter and urine collection system is in place per standard clinical decision * estimated length of placement of the foley is 48 hours minimum * burn injury ≥ 20% and ≤ 80% total body surface area (tbsa) * subject or subject's legally authorized representative is able to give informed consent before entering the study exclusion criteria: * currently pregnant or breastfeeding * clinical signs or symptoms of a urinary tract infection (uti) * clinical signs or symptoms of a vaginal infection * currently has bladder or urethral trauma * use of investigational drug/device therapy within the past 4 weeks
the long-term safety and effect of renal denervation

Conditions: Hypertension

Summary: the goal of this observational study is to learn about the effects of renal denervation in patients with resistant hypertension. the main question it aims to answer is: what are the long term effects of renal denervation on blood pressure and flow within the arteries? participants will undergo an assessment of their blood pressure, echocardiogram and invasive measurements of blood pressure and flow in the aorta and renal arteries before undergoing the renal denervation procedure. 6 months later these assessments will be repeated.

renal denervation is emerging as a succesful technique in the treatment of high blood pressure particularly for those people who's disease is resistant to drug therapy. it involves insertion of an catheter through the femoral artery and into the renal artery where it delivers a controlled radiofrequency ablation to the renal artery wall. the purpose of this ablation is to interupt the sympathetic nervous system which is inappropriately activated in hypertension. its beneficial effects on bp reduction has been borne out in a recently published randomised clinical trial which demonstrated a reduction in blood pressure in patients who underwent denervation compared to those managed with medication alone and it is now being used worldwide to manage hypertensive patients. the safety of this procedure has been demonstrated in the peri-operative setting and short term particularly regarding anatomical changes and kidney function. however, its effects have not been demonstrated with invasive imaging or physiological testing in the long term. therefore, the investigators recognise that a repeat assessment 6 months after denervation using invasive measures (to perform detailed assessments of the effects on aortic, flow and artery stiffness) would be of great benefit in stratifying this technique, which is likely to become widespread in the very near future. the investigators therefore plan to perform denervation in 20 patients and obtain detailed information on kidney and aortic blood pressure and flow. they will then reassess these parameters after 6 months in the same patients to ensure preservation of pressure, flow and energy transfer and document the effects of denervation on vascular stiffness.

Eligibility criteria:
inclusion criteria: * systolic blood pressure \>160mmhg despite 3 antihypertensive agents * egfr \>45 exclusion criteria: * secondary causes of hypertension * prior renal artery intervention * renal insufficiency * significant stenotic valvular heart disease * myocardial infarction, unstable angina or stroke within the preceding 6 months

Keywords: hypertension renal denervation
metabolic effects of treatment of chronic periodontitis in non-diabetic subjects

Conditions: Periodontitis; Prediabetes

Summary: this study was aimed at assessing the effects of non-surgical periodontal treatment (nspt) of chronic periodontitis on insulin sensitivity, glucose tolerance, and serum c-reactive protein(crp) level amongst non-diabetic subjects.

subjects with chronic periodontitis will undergo non-surgical periodontal treatment (nspt) consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution. periodontal parameters (plaque index, gingival bleeding index, pocket depth, and clinical attachment loss), insulin sensitivity using kitt, glucose tolerance using oral glucose tolerance test and serum crp level by immunoturbidimetry will be measured before and 3 months after the nspt.

Eligibility criteria:
inclusion criteria: * chronic periodontitis * non diabetic individual exclusion criteria: * known diabetes * periodontal treatment less than 6 months prior to inclusion * having less than 20 natural teeth

Keywords: periodontitis diabetes prevention impaired glucose tolerance insulin resistance
precision treatment of lumbar spine surgery through advanced nerve root blockade

Conditions: Radiculopathy Lumbar; Radiculopathy Sacral; Herniated Disc; Foraminal Stenosis; Stenosis, Spinal

Summary: the overall purpose of the study is to investigate whether selective spinal nerve root blocks can improve diagnostics of radiculopathy due to lumbar disc herniation (ldh), foraminal stenosis (fs), and recess stenosis (rs), and hence identify the patients that will benefit from surgical intervention.

the study is designed as a prospective randomized controlled trial, using a two-group stratified block-randomization, evaluating the effect of adding the outcome of a diagnostic snrb to surgical decision-making. stratification will be based on the study site. block size will be 4, 6, or 8 and in random order. all patients referred to our departments with suspected radiculopathy and radiological evidence of root compression are eligible for inclusion. patients will be randomized to either standard care or snrb after the consultation. results of the snrb will be available to the surgeon before deciding finally whether to operate or not. hence, the intervention adds the outcome of the diagnostic snrb to the shared surgical decision-making. study outline: baseline: demographics, oswestry disability index, eq5d, sf-36, nrs-lp, and nrs-bp will be recorded 1-month follow-up after surgery: oswestry disability index, eq5d, sf-36, nrs-lp, and nrs-bp will be recorded 3-months follow-up after surgery: oswestry disability index, eq5d, sf-36, nrs-lp, and nrs-bp will be recorded 12-months follow-up after surgery: oswestry disability index, eq5d, sf-36, nrs-lp, and nrs-bp will be recorded randomization: using redcap patients will be randomized to receive a snrb as part of the pre-operative workup or to direct operation. snrb-procedure: at aarhus university, the snrb will be performed using ct-guidance; at private hospital moelholm, the snrb procedure will be guided by fluoroscopy. drugs used are omnipaque (0,2 ml), betamethasone (0,5 ml) and bupivacain (0,5 ml)

Eligibility criteria:
inclusion criteria: * age \>18 years old * suspected lumbar radiculopathy persistent ≥ 8 weeks * radiological evidence of lumbar nerve root compression (herniated disc, recess stenosis, foraminal stenosis) exclusion criteria: * prior lumbar spine surgery * mental illness * language barrier in danish * severe physical co-morbidity * known allergies to medicine used in the study * pregnant * plans to move abroad during the next 12-months
physical activity for reduction of recurrence rate after adjuvant chemotherapy for localised colorectal carcinoma

Conditions: Colorectal Carcinoma

Summary: * feasibility of physical activity * increase of physical conversation * quality of life (optional) * vascular and metabolic effects

in this phase ii pilot project the feasibility of a defined medical physical activity should be verified for increased physical conversation. the study is conducted multicentric (single group) with a study population of 30 patients. after completion of adjuvant chemotherapy the patients will participate a defined physical training, 3 times per week within a time period of 52 weeks. planned study duration 2 years.

Eligibility criteria:
inclusion criteria: * complete resected, histologically confirmed adeno carcinoma of colon or rectal and condition after (neo-)adjuvant therapy either in (1) stage iii or (2) stage ii with risk factor * 4-16 weeks after the end of an adjuvant chemotherapy * ecog 0,1 * age \> 18 years * adequate liver-, nephro- and hemogram parameters * physical eligibility exclusion criteria: * significant comorbidities which exclude the participation * evidence of local recurrence or distant metastases * non-compliance of subject * other malignancy within the last 5 years (except: skin basalioma, cervix carcinoma in situ) * clinically significant cardiovascular diseases * treatment with beta blocker without possibility of adjustment * left bundle-branch block * simultaneous chemotherapy or radiotherapy * pregnancy

Keywords: physical activity
comparing breastmilk, massage, and no intervention for pain management during vaccination of term infants

Conditions: Pain Management

Summary: the goal of this clinical trial is to learn if breastmilk, massage or no intervention works for pain management during vaccination of term infants. it will also learn about the safety of these 3 approaches. the main questions it aims to answer is: does breastmilk, massage or no intervention works for pain management during vaccination of term infants? researchers will compare breastmilk, massage or no intervention for pain management during vaccination of term infants.


Eligibility criteria:
inclusion criteria: * neonates born at or after 37 completed weeks of gestation. * neonates scheduled to receive the dtc-hepb-hib-1 immunization. * time from last feeding should be greater than or equal to 30 minutes. exclusion criteria: * term neonates with major congenital abnormalities like limb contractures, limb deformities. * term neonates with any neurological conditions like hydrocephalus, cerebral palsy or birth asphyxia. * infants with acute illness. * infants randomized for no intervention but mothers breastfeed before pain evaluation to calm the babies from crying.
a study of octreotide depot vs saline control in pediatric hypothalamic obesity patients

Conditions: Hypothalamic Obesity

Summary: the extension protocol is designed to allow those patients randomized to placebo in the core portion of the protocol to receive a 6 month treatment of open label octreotide and allow those patients randomized to octreotide who appeared to benefit from treatment, to continue to receive octreotide.


Eligibility criteria:
inclusion criteria - patient must provide written informed consent exclusion criteria * any patient that experienced unresolved safety complications at any time during the original protocol csms995b2403 * patients with a history of gallstones or any patient developing gallstones during the course of the core protocol * patients for whom there are safety or tolerability concerns for continuing octreotide depot * any patient requiring additional treatment for their original cranial insult related to cranial trauma, or to tumor recurrence or its treatment refer to the original protocol for details of inclusion \& exclusion criteria. any patient granted a waiver to participate in the core protocol will be allowed to continue to participate in the extension protocol. other protocol-defined inclusion / exclusion criteria may apply.

Keywords: obesity