Kornimate/medical-research-clean huggingface dataset:
biodistribution study with 186 re-labelled humanised monoclonal antibody biwa 4 in patients with non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the primary objectives of this study is to assess the safety and tolerability of intravenously (i.v.) administered 186 rhenium-isotope (186re)-labelled bivatuzumab and to investigate the biodistribution and pharmacokinetics of 186 re-labelled bivatuzumab in patients with non-small cell lung cancer (nsclc)


Eligibility criteria:
inclusion criteria: * patients must have histological or cytological confirmation of non small cell lung cancer (nsclc) stage i, ii or iiia according to the staging system of the american joint committee on cancer (ajcc) * patients destined for resection of the tumour * patients over 18 years of age * patients younger than 80 years of age * patients who had given 'written informed consent' * patients with a life expectancy of at least 3 months * patients with a good performance status: karnofsky \> 60 exclusion criteria: * life-threatening infection, allergic diathesis, organ failure (bilirubin \> 30µmol/l and/or creatinine \> 150 µmol/l) or evidence of a recent myocardial infarction on electrocardiogram (ecg) or unstable angina pectoris * pre-menopausal women (last menstruation \<= 1 year prior to study start) * not surgically sterile (hysterectomy, tubal ligation) and * not practicing acceptable means of birth control, (or not planned to be continued throughout the study). acceptable methods of birth control include oral, implantable or injectable contraceptives * women with a positive serum pregnancy test at baseline * white blood cell count \< 3000/mm³, granulocyte count \< 1500/mm³ or platelet count \< 100000/mm³. details of prior chemotherapy and radiotherapy had to be known. * hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
a clinical study to compare professional treatments for dentinal hypersensitivity

Conditions: Dentinal Hypersensitivity

Summary: the objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * be in good general health as determined by the investigator/designee; and * have at least one tooth with a vas score of greater than or equal to 30 in response to the air challenge. exclusion criteria: * allergy to rosin or to pine nuts; * self-reported pregnancy or nursing; * severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; * active treatment for periodontitis; * fixed facial orthodontic appliances; * any diseases or conditions that might interfere with the safe completion of the study; or * an inability to undergo any study procedures.
intestinal colonization in newborn infants with enterostomy

Conditions: Newborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal Perforation

Summary: the human microbiota, a collection of microorganisms mostly settled in the gastrointestinal tract, plays a major role in the maintenance of the hosts' health and in development of disease as well. exposure to different conditions early in life contributes to distinct "pioneer" bacterial communities, which shape the newborn infants' development and influence their later physiological, immunological and neurological homeostasis. newborn infants with congenital malformations of the gastrointestinal tract (cmgit), necrotizing enterocolitis (nec), and spontaneous intestinal perforation (sip) commonly require abdominal surgery and enterostomy. while intestinal microbiota has been extensively studied in infants with anatomically uninterrupted intestine, the knowledge of longitudinal intestinal colonization in this population is scarce. this is an exploratory, observational, and longitudinal prospective study, primarily aimed to determine longitudinally the colonization of the proximal remnant intestine, in newborn infants with enterostomy after surgery (three weeks) for cmgit, nec and sip. the secondary aim is to explore the associations of the colonization with the mode of delivery, gestational age, postnatal age, duration of fasting, type of enteric feeding, antimicrobial therapy, h2-receptor antagonist therapy, and length of proximal remnant intestine.


Eligibility criteria:
inclusion criteria: newborn infants with enterostomy after surgery for cmgit, nec or sip, consecutively admitted exclusion criteria: newborn infants with diagnosed inborn errors of metabolism, those whose parents or legal guardians will not consent to participate or withdrawn the consent, and those who had not complete 21 days of follow-up.

Keywords: congenital malformations of the gastrointestinal tract enterostomy microbiota necrotizing enterocolitis newborn infants spontaneous intestinal perforation
chronic intradialytic exercise : a cardioprotective role

Conditions: Chronic Renal Failure

Summary: the main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function.

background: hemodialysis patients have a mortality rate 50 times higher than in the general population, and the cause remains cardiovascular in more than half of the cases. a deleterious morphological and functional cardiac remodelling is well established in these patients, the causes of which are both the presence of factors specific to renal disease (hemodynamic and non-hemodynamic) and co-morbidities (diabetes, hypertension, etc. .) but also to the hemodialysis (hd) procedure itself, due to the sudden hemodynamic changes it imposes, leading to repeated episodes of intradialytic hypotension (hid) and myocardial stunning. the latter are now documented as direct contributors to the increased mortality observed in hd patients compared to the general population. the introduction of intradialytic physical exercise in the therapeutic program of hd patient is now recommended and practised routinely in many countries, in scandinavia in particular. several meta-analyses have clearly established its safety. the beneficial role of chronic intradialytic exercise in improving dialysis efficiency, mental health and quality of life, as well as the inflammatory status of hd patients is also clearly demonstrated. chronic intradialytic exercise is also associated with improvements in overall fitness level, a parameter closely linked to cardiovascular mortality. applied acutely during dialysis, it could play a cardioprotective role (e.g; limiting myocardial stunning), allowing haemodynamic and cardiac functional stabilization during hd. however, to our knowledge, no study to date has investigated the long-term effects of intradialytic exercise on remodelling and overall and regional heart function. aims: the main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function. the secondary objectives are to evaluate the effect of acute intradialytic exercise on myocardial stunning as well as the effect of chronic physical exercise on macro and microcirculatory vascular function, inflammation, physical fitness and health-related quality of life.

Eligibility criteria:
inclusion criteria: * no medical contraindication to physical activity * life expectancy greater than 6 months * patients on haemodialysis for more than 3 months exclusion criteria: * pregnancy * valvular heart disease, * unstable coronary artery disease * arteriopathy obliterating of the lower limbs stage iii and iv * musculoskeletal problems * severe respiratory disease * bmi\> 35 * pacemaker, cardiac stimulation and automatic implantable defibrillator * heart transplant * uncontrolled arterial hypertension * ejection fraction \<45%

Keywords: exercise hemodialysis
safety and efficacy study of bimatoprost/timolol fixed combination in patients with glaucoma or ocular hypertension

Conditions: Ocular Hypertension

Summary: the purpose of this study is to assess the safety and efficacy of bimatoprost/timolol fixed combination in patients with glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * clinical diagnosis of glaucoma or ocular hypertension in both eyes * patient requires iop-lowering drug in both eyes exclusion criteria: * uncontrolled medical conditions * contraindication to beta-adrenoceptor antagonist therapy
study of hs135 in obese patients with pulmonary hypertension and heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction; Pulmonary Hypertension

Summary: a study of hs135 for the treatment of in obese patients with pulmonary hypertension and heart failure with preserved ejection fraction (ph-hfpef)

phase 1b, multicenter, double-blind, placebo-controlled, multiple ascending dose study assessing the pharmacokinetics, safety, pharmacodynamics, and efficacy of hs135 in obese patients with pulmonary hypertension and heart failure with preserved ejection fraction

Eligibility criteria:
inclusion criteria: patients are eligible to be included in the study only if they meet at least all the following criteria: 1. male or female, \>18 years of age. 2. cardiomems™ heart failure system implanted during standard of care at least 90 days before screening. 3. established diagnosis of hfpef with left ventricular ejection fraction (lvef) at least 45% as measured by echocardiography during screening. 4. new york heart association (nyha) class ii, iii or iv heart failure symptoms. 5. bmi ≥ 30 kg/m2. 6. ability to adhere to study visit schedule and understand and comply with all protocol requirements. exclusion criteria: patients will be excluded from the study if they meet any of the following criteria: 1. decompensated heart failure. 2. admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to screening. 3. implantation of cardiac resynchronization therapy (crt) device within 90 days prior to screening. 4. planned cardiovascular revascularization or major cardiac surgery or planned implantation of crt device. 5. history of heart transplant or on heart transplant list. 6. uncontrolled systemic hypertension. 7. patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study. 8. patients who have full pneumonectomy or a severe chronic pulmonary disorder that in the opinion of the investigator increases the risk of participating in the study.
ems providers' health initiative study

Conditions: Shift-work Disorder

Summary: this study aims to explore dietary factors that influence glycemic control in night shift ems providers and to test the feasibility of a dietary intervention among these providers.

this study can be broken down into two phases. both phases will take place over the course of 3 weeks. during the first week, participants will be scheduled for a single 60-90 minute zoom appointment. during this appointment, informed consent will be obtained, participants will provide health and demographic information, complete several questionnaires, and be familiarized with study protocols. the following week, participants will wear a continuous glucose monitor, actigraph activity monitor, document everything they have to eat and drink, and rate their daily stress levels. participants will continue this during the final week and will be randomized to consume either a 2:1 or 1:1 protein to carbohydrate ratio during the night shift during this week.

Eligibility criteria:
inclusion criteria: * emergency medical service (ems) provider * works night shift only for at least one year * provides patient care as primary duty exclusion criteria: * diagnosis of a metabolic disease (i.e. diabetes, prediabetes, metabolic syndrome) * taking medication to lower blood glucose * pregnant or planning to become pregnant * diagnosis of kidney disease or impairment * allergies or intolerances to study foods * digestive disorder

Keywords: ems night shift nutrition insulin resistance circadian rhythm
prognostic significance of lymph node ratio in rectal cancer on overall survival

Conditions: Cancer, Rectum

Summary: this study was conducted to compare the significance of lymph node ratio and absolute count of positive lymph node count on overall survival in patients with rectal cancer who underwent resection with curative intent

retrospective cohort study carried on 229 patients with non-metastatic rectal cancer, admitted in tertiary hospitals along 10 years, between 2012 to 2022, and underwent radical resection surgery with curative intent. exclusion criteria included patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, early post-operative recurrence or death within 3 months. demographic, histopathological, follow up and outcome data were collected. demographics included age, gender, family history, and chief complaint at presentation. histopathological data included tumor site, grade, vascular-perineural invasion, total number of lymph nodes removed, and positive lymph nodes. lymph node ratio was defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in histopathology specimen. survival was calculated for each patient based on time of surgery to time of death statistical analysis will be used to evaluate the effect of lymph node ratio on overall survival.

Eligibility criteria:
inclusion criteria: * patient with rectal cancer of stage i-iii. * patients underwent radical resection with curative intent. exclusion criteria: * patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers. * early post-operative recurrence, or death within 3 months.

Keywords: cancer rectum lymph node ratio overall survival prognosis
dexmedetomidine-ketamine in femur proximal fracture patients

Conditions: Pain

Summary: * comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine * lateral position for spinal anesthesia in femur proximal fracture patients

* dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) 10 minutes loading. * after 10 minutes of drug infusion, patients are prepared for spinal anesthesia. * pain scale and quality of patient positioning are measured three times (lateral position, chest-knee position, intrathecal local anesthetics injection) * when patients have severe pain during intraoperative period, fentanyl 50 mcg will be intravenously inject. * patients will be injected propofol 10mg when they have agitation signs during operation. * vital signs, bispectral index, korean version of mini mental status examination, verbal rating scale,fentany/propofol consumption, frequency of intrathecal injection

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists classification 1-3 patients * \>20 years old exclusion criteria: * patients refuse * dementia patients, cooperation difficult patients * anaphylaxis of dexmedetomidine, ketamine, local anesthetics * heart problem (bradycardia, atrioventricular block)

Keywords: dexmedetomidine ketamine pain
naloxegol and opioid-induced constipation

Conditions: Constipation; Constipation Drug Induced

Summary: this is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.

this is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-op regimen. there will be 140 subjects per study group. the patient and treating physician/nurse will be blinded as to which group the subject is assigned. on the day of surgery, subjects in both groups will complete a questionnaire to assess compliance with prescribed pre-operative regimen. subjects in both groups will receive post-operative bowel regimen in the cardiovascular intensive care unit (cvicu) according to current standard of care, including procedures for rescue medications for constipation prevention and induction of a bowel movement.

Eligibility criteria:
inclusion criteria: * scheduled to undergo elective cardiac surgery at bethesda north trihealth hospital * admitted to bethesda north trihealth hospital cvicu post-surgery exclusion criteria: * medically unstable * cognitive deficits that impair the patient's ability to understand the informed consent * language barriers * patient has a documented diagnosis of one of the following: crohn's disease; ulcerative colitis; history of bowel surgery that will impact absorption of study drug (as deemed by physician); history of small bowel obstruction * chronic constipation requiring subject to take one of the following medications on a daily basis prior to time of consent: linzess, trulance, amitza, senna/senokot, colace, dulcolax, miralax, metamucil * patients on following medications prior to time of consent: diltiazem, verapamil, amiodarone, ketoconazole, clarithromycin/ erythromycin, antivirals * conditions that present an increased risk of bowel perforation (as determined by the physician) * pre-existing diagnosis of opioid-induced constipation and receiving naloxegol as a treatment by their physician

Keywords: opioid-induced constipation (oic)
functional recovery changes in subacute stroke patients

Conditions: Sub-acute Stroke

Summary: in subacute stroke patients, dynamic time series data of brain imaging and motor function measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset


Eligibility criteria:
inclusion criteria: * at least 19 years of age hemiplegic stroke patients * subacute-phase ischemic or hemorrhagic stroke patients within 7 days of onset * functional ambulation category scale (fac) of 3 or less, 7 days of onset, * a person who understands and voluntarily participates in this study and signs a research agreement exclusion criteria: * user of artificial heartbeat * patients with claustrophobia * patients with metal implants * patients who are contraindicated for other common mri * patients with mild motor impairment with an fma score of 80 or higher * patients whose conscious state is coma and who have no response at all * patients who can not independently gait with the modified rankin scale (mrs) score of 4 or more before the onset of disease

Keywords: motor function recovery gait magnetic resonance imaging
android mobile devices to assist routine anticipation for autistic children

Conditions: Autism

Summary: the objective of this work is to develop an application to run on a mobile device android tablet that features visual routines for autistic children.

autism is a disorder characterized by social deficits, and among others by changes in communication. the diagnosis of this disorder remains accomplished by direct assessment the individual's behavior, according to specific clinical criteria present the classification systems of the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv). therapists teach autistic to communicate with the help of symbols and auxiliary anticipation and communication routines, usually using the picture exchange communication system (pecs), or photos. however these are presented in transition pecs cards and do not follow the children in activities that develop outside the school environment. the objective of this work is to develop an application to run on a mobile device android tablet that features the visual routines. in this way the routines can be accessed outside the school environment. this technology is easy to use and facilitates data entry by touching the screen, was developed using the unified modeling language (uml), javascript, apache web server and web browser chrome. the application validation, will be held with 10 autistic and 2 teachers from the center of inclusion and support for autistic. teachers should insert the activities programmed for each autistic student. tablet in student performance in communicating with this tablet will be measured. parents or guardians knowledge with the pecs system will be trained and will be evaluated on their autonomy inserting images, audio and subtitles. the application should aid communication, cause the autistic understand the sequence of events in daily life, decreasing their aggression because of not knowing what will be their next activity. participation in this research poses no risk or harm the concerned person. if during the research participant decides not anymore have the freedom to do so without incurring any damage you. the technical validation proposal is necessary for it to be used by people with autism. if validated in a positive way, the technique could improve the quality of life of these people and their families.

Eligibility criteria:
inclusion criteria: * have a diagnosis of autism development by dsm-iv * have sufficient motor skills to perform operations on a tablet * be aware of pecs * children should be accustomed to the visual routines used in exclusion criteria: * have visual impairment

Keywords: autism
evaluation of the integrated home dialysis model

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to evaluate which home dialysis modality pattern (home hemodialysis \[hhd\], peritoneal dialysis \[pd\] or a combination of both, e.g. pd and then hhd) allows for the longest home dialysis survival, as defined by the time dialysed in a home environment. the investigators hypothesize that patients transferred from one home modality to another will have a longer home dialysis survival compared to patients treated only with pd or hhd.


Eligibility criteria:
inclusion criteria: * patients with pd/hhd 90 days after rrt initiation between january 1, 2000 and december 31, 2012 reported in anzdata * ≥ 18 years exclusion criteria: * less than 90 days of dialysis * \< 18 years * patients transferred to australia/new zealand after initiation of dialysis in another country

Keywords: end-stage kidney disease peritoneal dialysis home hemodialysis technique survival patient survival