Kornimate/medical-research-clean huggingface dataset:
prematurity education in high risk pregnancies

Conditions: Prematurity; High Risk Pregnancy

Summary: prematurity is associated with significant morbidity and mortality. given the high risk of death and disability, it is important for parents to understand the complications of prematurity so they can make decisions for their child. unfortunately, these discussions often occur in the acute setting of threatened preterm labor when stress and anxiety make comprehension difficult. this study aims to improve parental understanding by providing early education of prematurity in the clinic setting for patients at high risk of preterm delivery.


Eligibility criteria:
inclusion criteria: 1. pregnant women between 22 0/7 and 34 6/7 weeks gestational age at high risk for premature delivery. 1. premature delivery defined as \<37 0/7 weeks gestation. 2. any pregnant woman seen in the maternal-fetal medicine clinic deemed to be at high risk for premature delivery. 2. pregnant women 16 years and older. 3. pregnancy with singleton or twin gestation. 4. no major congenital malformation. 5. women who are english speaking. exclusion criteria: 1. pregnant women \ 35 0/7 weeks gestational age. 2. pregnant women less than 16 years old. 3. multiple gestation greater than twins (triplets, quadruplets, etc). 4. known major congenital malformation. 5. women who are non-english speaking.

Keywords: antenatal counseling education
starter kit study in insulin naïve patients

Conditions: Diabetes Mellitus, Type 2

Summary: the concept consists of an initial period (two weeks) of intensive data capture by use of continuous glucose monitoring (cgm) during basal insulin initiation, followed by a second period (variable duration) of basal insulin titration guided by self monitored blood glucose. data captured during the first period are used as input to an algorithm that estimates the optimal daily dose for the individual patient. the estimated optimal daily dose is used to guide the titration of the basal insulin during the second period. the goal is to safely and successfully achieve blood glucose targets. the concept is based on the use of basal insulin degludec (tresiba, novo nordisk a/s).


Eligibility criteria:
inclusion criteria: * type 2 diabetes * age 18-75 years * hba1c 53-86 mmol/mol (7.0-10.0%) * bmi 20-40 kg/m2 * insulin-naïve * willingness to use cgm consistently during the study period and send/receive data and dose advice to/from hcp via a mobile phone * signed informed consent prior to any study procedures exclusion criteria: * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods * active proliferative retinopathy * mean blood glucose \> 15 mmol/l the week prior to screening * blood glucose \> 20 mmol/l on the screening day * non-fasting ketones \> 0,5 mmol/l on the screening day * use of sulfonylurea within 14 days prior to or during the study period * change in other antidiabetic medicine than basal insulin during the study period * use of corticosteroids within 30 days prior to or during the study period * marked change in lifestyle within 30 days prior to or during the study period as assessed by the investigator * people with type 2 diabetes that suffer from conditions which make tight diabetes control undesirable, e.g. severe cardiovascular disease, according to the investigator * other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation * overall treatment
a shared decision-making training for inpatients with schizophrenia

Conditions: Schizophrenia; Schizo-affective Disorder

Summary: "shared decision-making" is being promoted as a promising approach for engaging patients with schizophrenia in medical decisions and improving satisfaction and adherence. to implement shared decision-making, both physicians and patients should commit to it and engage in a mutual decision process. most research, however, has addressed interventions that either focus on the doctors' side (e.g. "communication skills") or on informing patients about treatment options (e.g. "decision aids"). these approaches have been shown to be feasible in clinical practice but had no strong effects on treatment patterns or adherence, possibly because they were insufficient to motivate and enable patients to engage actively in decision-making. moreover, these interventions still rely on the doctor's willingness to share decisions, which has been shown to vary considerably. to overcome these limitations and since many patients do not feel competent to participate in decision-making we developed an intervention that focuses on patients' communicative competencies. this intervention, a five session group-training, will be implemented for inpatients suffering from schizophrenia.


Eligibility criteria:
inclusion criteria: * age 18-65 * icd diagnosis f2 * sufficient german language skills exclusion criteria: * debility
efficacy and safety of zoledronic acid in acute spinal cord injury: prevention of bone loss

Conditions: Bone Loss

Summary: this is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. the goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. outcome measures will include bone density determinations over a one year period.


Eligibility criteria:
inclusion criteria: 1. men and women 2. age 18 years and older 3. spinal cord injury within 8 weeks of study entry 4. asia ais a or b 5. medically stable in the opinion of their physiatrist 6. able to have dexa performed 7. able to return for follow-up at 6 and 12 months exclusion criteria: 1. vitamin d deficiency 2. hypocalcemia 3. renal insufficiency (estimated creatinine clearance \<30ml/min) 4. abnormal thyroid hormone status 5. abnormal mental status 6. osteoporosis at the hip or spine by dexa

Keywords: spinal cord injury osteoporosis bone loss zoledronic acid bisphosphonate
lung sbrt motion management (gcc 1619)

Conditions: Lung Cancer

Summary: real-time optical surface monitoring data will be acquired from 44 human patients with primary or metastatic lung lesions during and after their 4dct scan (standard-of-care at our institution). a patient-specific 4d model will be developed using the raw 4dct projections time-correlated with real-time surface monitoring. in addition, before delivering each dose fraction (3 - 5 for lung sbrt), we will acquire three 15s kv fluoroscopic image acquisitions, time-correlated with optical surface monitoring. the acquisitions will be distributed over three well-spaced beam angles, e.g., every 4th angle for a 12-field plan.

surface monitoring procedure -the procedure is expected to last approximately 15 minutes after the end of the 4dct scan, which is the standard-of-care for lung sbrt treatments at our institution. the procedure will consist of real-time surface tracking using the visionrt system of the thoracic and/or abdominal region. continuous audiovisual contact will be maintained with the subject during scanning. each individual will be informed that they can stop the procedure at any point. fluoroscopic imaging procedure - fluoroscopic imaging will be performed in the treatment room with the patient lying in treatment position. three 15s acquisitions will be performed under free breathing conditions, each from a different beam angle, using the on-board kv imager. audiovisual contact will be maintained at all times with the patient. data collection and management: an id number will be assigned to each separate patient, and the correlation between id number and patient name and medical record number will be kept in a password-protected file in dr. amit sawant's office. the database of information extracted from the medical record and radiation treatment records for each patient will be stored in an excel file on a computer with password protection. all image data will be de-identified by dr. sawant before his research team analyzes them.

Eligibility criteria:
inclusion criteria: 1. eligible disease(s)/stage(s) - patients with primary or metastatic lung lesions to be treated using stereotactic body radiotherapy (sbrt) will be eligible for this study. 2. allowable type and amount of prior therapy - any types and amounts of prior therapy will be allowed for this study. 3. age restriction and/or gender/ethnic restrictions - patients must be greater than or equal to 18 years of age. there are no gender or ethnic restrictions. 4. life expectancy restrictions - none. 5. ecog or karnofsky performance status - karnofsky performance status of 50 or greater 6. requirements for organ and marrow function - none. 7. ability to understand and the willingness to sign a written informed consent document. 8. tumor motion \> 5 mm, maximum gtv dimension \< 50 mm - per guidelines established by the aapm task group 7612 and rtog 0236.13 exclusion criteria: 1. children (age \<18) 2. women who are pregnant or trying to get pregnant 3. pain in supine position 4. karnofsky performance status \< 50

Keywords: lung cancer sbrt motion management
a study to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of ro7444973 in participants with unresectable and/or metastatic mage-a4-positive solid tumors

Conditions: Solid Tumors

Summary: this is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of ro7444973.the aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ro7444973 in participants with unresectable and/or metastatic melanoma-associated antigen a4 (mage-a4)-positive, solid tumors, carrying the hla-a\*02:01 allele.


Eligibility criteria:
key inclusion criteria: * unresectable and/or metastatic solid tumors that have received standard-of-care (soc) therapies previously and have no other soc options available * confirmed hla-a\*02:01 haplotype * confirmed mage-a4 expression * radiologically measurable disease according to response evaluation criteria in solid tumors (recist) v1.1 * life expectancy of \>/=12 weeks * eastern cooperative oncology group (ecog) performance status of 0-1 * absence of rapid disease progression, threat to vital organs or non-irradiated lesions \>2 cm in diameter at critical sites * no significant ongoing toxicity from prior anticancer treatment * adequate hematological function * adequate liver function * adequate renal function * if applicable, willingness to use contraceptive measures. key exclusion criteria: * history or clinical evidence of cns primary tumors or metastases * another invasive malignancy in the last 2 years * uncontrolled hypertension * significant cardiovascular disease * known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic or other infection * current or past history of cns disease * dementia or altered mental status that would prohibit informed consent * active auto-immune disease or flare within 6 months prior to start of study treatment * expected need for regular immunosuppressive therapy or with systemic corticosteroids * insufficient washout from prior anti-cancer therapy * prior treatment with a bispecific t-cell engaging or adoptive cell therapy.
analysis of the results from influenza rapid test a positive and h1n1 real time rt-pcr

Conditions: H1N1 Influenza Virus

Summary: the first outbreak of a new h1n1 influenza pandemic originated in the north america in april 2009. as of july 1, 2009, a total of 77,201 cases were accumulated in 103 countries around the world and the mortality rate of was about 0.43%. alignment and analysis on gene sequences of the new h1n1 influenza virus found that it contains extremely homologous gene composition with that of the swine influenza viruses (swine flu) identified in europe and north america in last century. thus the virus strain was later renamed as a novel influenza h1n1. in general, the symptoms caused by the new influenza h1n1 infection was very similar to those resulted from seasonal influenza viral infection. thus, it is difficult to distinguish the various influenza strains responsible for the infections only by clinical appearance. to compare the accuracy, specificity and sensitivity and speed in identifying the new influenza h1n1 in suspected cases, the investigators extracted rna from influenza a-positive reactive specimens identified by a influenza rapid test, for a real-time pcr method to further detect the presence of swine h1 gene. in addition, the titer of h1n1 virus, the color development on the test stripe and clinical symptoms in patients were significantly associated. finally, real-time pcr products were subjected to sequence determination to explore potential new influenza pathogenicity, transmissibility and drug usage.


Eligibility criteria:
inclusion criteria: * influenza rapid test influenza a(+) b(-) * influenza rapid test influenza a(+) b(+) * influenza rapid test influenza a(-) b(-) was negative control exclusion criteria: * influenza rapid test influenza a(-) b(+)

Keywords: h1n1 influenza virus swine flu real time rt-pcr
lifepearl-iri pharmacokinetic study

Conditions: Metastatic Colorectal Cancer; mCRC

Summary: the primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of lifepearl microspheres loaded with irinotecan in the treatment of liver predominant mcrc by chemoembolization.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years old * histologically proven mcrc * at least 1 measurable liver metastasis \> 1 cm (mrecist) liver predominant disease ( ≥ 80% of metastatic disease confined to the liver) * no portal vein involvement * performance status 0 or 1 * life expectancy ≥ 3m * adequate hematologic function (anc≥1.5 10\^9/l; plt≥75 10\^9/l; inr (international normalized ratio) ≤1.3) * adequate liver and renal function (total bilirubin ≤2.0 mg/dl; albumine 2.5g/dl; serum creatinine ≤2.0 mg/dl; alt (alanine transaminase),ast (aspartate transaminase) ≤5 times uln) * less than 50% liver tumor replacement * patient has provided written informed consent * patient is affiliated to social security or equivalent system (france only) exclusion criteria: * eligible for curative treatment (resection/rfa) history of hepaticocholangiojejunostomy or obstructive biliary disease (with/without previous treatment) * previous liver embolization * contraindication for intra-arterial embolization and local irinotecan administration * allergy to contrast media * patient is co-treated with potent cyp3a4/ugt1a1 (cytochrome p450 3a4/uridine diphosphate glucuronosyltransferase 1a1) inducers, i.e. rifampin, rifabutin, phenytoin, phenobarbital, carbamazepine and st john's wort * patient is currently participating in a clinical trial with an investigational drug or a device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints * in the investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study * patient is under judicial protection (france only)

Keywords: liver metastatic
a study for the treatment of mania associated with bipolar i disorder in children and adolescents

Conditions: Bipolar I Disorder

Summary: the purpose of the study is to evaluate the long-term safety profile of the investigational medication depakote er in the treatment of bipolar i disorder, manic or mixed episode, in children and adolescents ages 10-17.


Eligibility criteria:
inclusion criteria: * subject is between 10 and 17 years of age, inclusive, on day 1 and weighs at least 60 lbs (27 kg). * subject has a current psychiatric diagnosis of bipolar i disorder, manic or mixed episode, based on the k-sad-pl interview and dsm-iv-tr criteria. * subject is an outpatient in a manic or mixed episode with a ymrs score of greater than or equal to 16 during screening and at day 1. exclusion criteria: * has an axis i disorder other than attention deficit hyperactivity disorder (adhd), obsessive compulsive disorder (ocd), oppositional defiant disorder (odd), conduct disorder (cd), panic disorder, enuresis, encopresis, parasomnias, agoraphobia, specific phobia, social phobia or separation anxiety disorder; or subject has an axis ii disorder that would interfere with the subject's ability to comply with study procedures or confound interpretation of the study results. subject meets dsm-iv-tr criteria for substance abuse within the month prior to screening, or meets the criteria for substance dependence within the three months prior to screening, or exhibits signs of drug or alcohol intoxication or withdrawal at day 1. * is expected to require hospitalization for the current manic or mixed episode. * is violent, homicidal, or suicidal such that, in the opinion of the investigator, the subject is at significant imminent risk of hurting self or others. * has a history of a chronic or acute medical disorder that, in the opinion of the investigator, would preclude compliance with the protocol, or confound interpretation of the study results. * has a history of, or is suspected of having a seizure disorder. * has any central nervous system (cns) neoplasm, cns infection, demyelinating disease, degenerative neurological disease, or any progressive cns disease. * has platelet count less than or equal to 100,000/µl * has blood chemistry alt/ast value(s) greater than or equal to 2 times upper limit of normal at screening. * is taking a protocol allowed medication for adhd that has not been stable for at least 3 months prior to day 1, or that, in the investigator's opinion, may be exacerbating mood symptoms. * requires anticoagulant drug therapy.

Keywords: bipolar i disorder depakote
effects of distraction methods on pain perceptions and anxiety levels in children during the blood collection

Conditions: Acute Pain; Nursing Caries

Summary: aim:this study was conducted to investigate the effects of music, kaleidoscope and video watching methods on children's pain perception and anxiety level during the blood collection procedures. methods: this randomized controlled experimental study was carried out with 134 children in the 5-10 age group in the pediatric blood collection unit of a training and research hospital between august and november 2018. in the study, nonpharmacological methods were applied to the children in the experimental groups (music group (n=33), kaleidoscope group (n=36), video group (n=31). the routine blood collection procedure was used for the children in the control group (n=34). the data were collected using the "introductory information form", "children's fear and anxiety scale (cfas)", and the "wong-baker faces pain rating scale (wb-fprs)".


Eligibility criteria:
inclusion criteria: * being healthy * ability to express himself/herself verbally * no analgesic taken in the last 6 hours * having no visual or auditory problems exclusion criteria: * chronic disease * mental disease * neurological disease

Keywords: acute pain anxiety children blood collection nursing
hd17 for intermediate stage hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: this study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (pfs).


Eligibility criteria:
inclusion criteria: * hodgkin lymphoma * cs i, ii with risk factor (stage iib with risk factor 1 or 2 are not included) * large mediastinal mass (\>1/3 of maximum transverse thorax diameter) * extranodal involvement * elevated esr * 3 or more involved nodal areas * written informed consent exclusion criteria: * leucocytes \<3000/µl * platelets \< 100000/µl * hodgkin lymphoma as composite lymphoma * activity index (who) \>2

Keywords: hodgkin lymphoma intermediate stage pet
xlif decade plate system study

Conditions: Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Scoliosis

Summary: the primary objective of this study is to evaluate the safety and performance of the nuvasive xlif decade plate system as measured by patient-reported outcomes (pros), radiographic outcomes, and reported complications.

this study is a prospective, single-arm, multicenter study to evaluate the safety and performance of the xlif decade plate in patients undergoing a thoracic and/or lumbar interbody fusion, at one or two levels, with supplemental fixation using a lateral plate. consecutive patients at a given site who meet all eligibility requirements will be asked to consent to participate in the study. eligible patients include those with degenerative conditions in the thoracic and/or lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. once enrolled in the study, subjects will undergo xlif surgery with lateral plating using the decade plate. at least 75 subjects will be enrolled and will be followed for 24 months after surgery.

Eligibility criteria:
inclusion criteria: 1. patients who are ≥18 years of age at the time of consent 2. planned interbody fusion surgery using the decade plate system in conjunction with an interbody implant to treat one or two levels in the thoracic and/or lumbar spine for 1. degenerative disc disease 2. spondylolisthesis 3. scoliosis, kyphosis, lordosis 4. spinal stenosis 5. spondylolysis 6. pseudoarthrosis or failed previous spine surgery 3. able to undergo surgery based on physical exam, medical history, and surgeon judgment 4. understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study exclusion criteria: 1. use of posterior fixation for the scheduled surgery note: should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study 2. patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) 3. use of bone growth stimulators postoperatively 4. active smoking within 6 weeks before surgery 5. patient has known sensitivity to materials implanted 6. systemic or local infection (latent or active) or signs of local inflammation 7. patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment 8. pregnant, or plans to become pregnant during the study 9. patient is a prisoner 10. patient is participating in another clinical study that would confound study data