Kornimate/medical-research-clean huggingface dataset:
panitumumab-irdye800 in detecting cancer in participants with lung cancer during surgery

Conditions: Lung Carcinoma; Metastatic Malignant Neoplasm in the Lung; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8

Summary: this phase i/ii trial studies the best dose and timing of panitumumab-irdye800 in detecting cancer in participants with lung cancer during the surgery. panitumumab-irdye800 is a combination of the antibody drug panitumumab and irdye800cw, an investigational dye that can be seen using a special camera. panitumumab-irdye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.

primary objectives: i. to determine the optimal dose and timing of panitumumab irdye800 infusion for identifying lung cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio. secondary objectives: i. determine the safety and tolerability of the panitumumab irdye800 as an imaging agent in subjects undergoing resection of lung cancer. ii. determine whether the primary lung tumor or positive lymph nodes can be detected by near-infrared (nir) fluorescence imaging with panitumumab irdye800 but not by white light imaging. outline: this is a phase i, dose-escalation study of panitumumab-irdye800 followed by a phase ii study. participants receive panitumumab- irdye800 intravenously (iv) over 60 minutes on day 0, and then undergo nir and surgery within 1-5 days. after completion of study treatment, participants are followed up for up to 30 days.

Eligibility criteria:
inclusion criteria: * patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven * patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer * karnofsky performance status of at least 70% or eastern cooperative oncology group (ecog)/zubrod level 0-2 * hemoglobin ≥ 9 gm/dl * white blood cell count \> 3000/mm\^3 * platelet count ≥ 100,000/mm\^3 * serum creatinine ≤ 1.5 times upper reference range exclusion criteria: * received an investigational drug within 30 days prior to first dose of panitumumab-irdye800 * myocardial infarction (mi); cerebrovascular accident (cva); uncontrolled congestive heart failure (chf); significant liver disease; or unstable angina within 6 months prior to enrollment * history of infusion reactions to monoclonal antibody therapies * pregnant or breastfeeding * magnesium or potassium lower than the normal institutional values * subjects receiving class ia (quinidine, procanamide) or class iii (dofetilide, amiodarone, sotalol) antiarrhythmic agents * subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis * prisoners, institutionalized individuals, and patients unable to consent for themselves
ct perfusion changes in gi cancer during adenosine vasodilation test

Conditions: Esophageal Cancer; Gastric Cancer

Summary: the aim of this study was to investigate changes in abdominal tissue perfusion during adenosine vasodilation. our hypotheses were that ct perfusion measurements are altered by changes in the circulatory system mediated by adenosine, and a more differentiated assessment of the circulatory capacity of abdominal tumours could be achieved by sequential rest and adenosine vasodilation ct perfusion measurements.


Eligibility criteria:
inclusion criteria: * tumour larger than 1.5 cm on diagnostic ct * normal serum creatinine * age above 18 * informed written and oral consent. exclusion criteria: * contrast allergy or contrast induced nephropathy * bmi \> 40 * asthma or chronic obstructive lung disease * heart failure (nyha iii+) * heart conduction disorder * atrial fibrillation * 2nd/3rd heart block * long qt syndrome * wolf parkinson white syndrome * moderate / severe aortic stenosis * haemodynamic contraindications for adenosine, systolic pressure below 90
comparison of levothyroxine formulations in the treatment of congenital hypothyroidism

Conditions: Congenital Hypothyroidism

Summary: observational, retrospective, prospective, pharmacological, single-centre, non-profit study. the aim is to evaluate, in newborns diagnosed with congenital hypothyroidism, the medium- and long-term efficacy and safety of the new formulation of levothyroxine in oral solution, compared to the liquid drop formulation and the tablet formulation. the study will involve male and female patients referred to the neonatal screening centre at the centre for endocrine-metabolic diseases of the paediatrics unit, irccs azienda ospedaliero-universitaria di bologna policlinico di s. orsola, italy, who tested positive for congenital hypothyroidism.

the prospective cohort consists of patients with congenital hypothyroidism identified through neonatal screening, who come for observation at the centre for endocrine-metabolic diseases of the pediatrics unit, irccs azienda ospedaliero-universitaria di bologna policlinico di s. orsola, italy, from the approval of the study until the number of patients stipulated in the protocol is reached, which is expected to be achieved in about 4 years. the recruited patients will be assigned, based on the therapy taken in normal clinical practice, to a pharmacological group (group a: drops, group b: oral solution, group c: tablets), and their medical history, clinical and biochemical data will be collected at diagnosis. the retrospective cohort includes children born from january 1, 2019 to the date of study approval, who came for observation at the centre for endocrine-metabolic diseases of the pediatrics unit, irccs azienda ospedaliero-universitaria di bologna policlinico di s. orsola, italy, for congenital hypothyroidism identified by neonatal screening. these patients had levothyroxine therapy in one of the three formulations (solid, drops, oral solution) assigned according to normal clinical practice and will therefore be divided into 3 groups as for the prospective cohort. for these patients, retrospective collection and analysis of anamnestic, clinical, biochemical and radiological data and clinical, biochemical and neurocognitive follow-up is planned with the same timelines defined for the prospective cohort.

Eligibility criteria:
inclusion criteria: newborn screening test positivity for congenital hypothyroidism; subjects born in emilia-romagna region, italy, and undergoing diagnostic confirmation and initiation of replacement therapy; diagnosis-confirmed subjects who underwent l-t4 replacement therapy in the first month of life at center for endocrine-metabolic diseases, pediatrics units of the irccs azienda ospedaliero-universitaria di bologna policlinico di s.orsola, italy; age ≤11 years old; obtaining informed consent from parents and/or legal guardians and assent from minors included in the study. exclusion criteria: known chromosomal abnormalities or complex syndromes; patients transferred to another center before completion of at least one year of follow-up from the start of therapy; patients who started therapy at another center.
growth response in short children suffering from a disease with growth retardation and treated with somatropin

Conditions: Idiopathic Short Stature

Summary: growth hormone therapy will improve the height of short statured children with pathological conditions that lead to growth retardation. growth hormone therapy will show an increase in height velocity \>1 sd compared to pretreatment height velocity. and the therapy will be safe.

growth hormone (gh, somatropin, e.g. genotropin®) is approved in the treatment of children in specific indications. however, besides the benefit in approved indications, a benefit can also be achieved in other pathological conditions that lead to growth retardation. however, because of their relative low frequency and the long duration of gh studies in children, few data or only case reports on gh treatment are available in these conditions. nevertheless, published data have suggested a benefit of gh treatment in children suffering from some of those diseases and pediatric endocrinologists sometimes request gh treatment for those children to improve growth rate. this protocol is designed to allow such children with severe growth retardation to be treated with gh and will allow those children to be carefully followed-up and finally evaluated at the end of the gh treatment period.

Eligibility criteria:
inclusion criteria: * severe growth retardation (\< -2,5 height sds and annual growth velocity (hv sds) \< 0 sd according to reinken (1992) and parental adjusted target height \< -1 sd according to tanner (1986) * chronological age \> 4 and \< 10 years, prepubertal children; for girls: tanner breast stage b = 1, for boys: testis volume ≤ 3 ml * any disease which is not part of the registered indications for gh treatment in germany * written informed consent from both parents and from the patients if she/he is able to receive and understand the information * gh treatment requested by an expert in pediatric endocrinology exclusion criteria: * participation in any other clinical study * unable to follow the and/or comprehend the protocol ( e.g. severe mental retardation) * previous history of intolerance or hypersensitivity to the study drug * history of malignancy * chromosomal anomalies with increased risk for malignancy

Keywords: short stature
study for novel coronavirus pneumonia (ncp)

Conditions: Novel Coronavirus Pneumonia

Summary: to develop practical and effective clinical diagnosis and treatment schemes for the control of novel coronavirus pneumonia.

by retrospectively analyzing the clinical epidemiological characteristics of the novel coronavirus pneumonia and the current diagnosis and treatment schemes, as well as in-depth analyzing the disease development process and outcome trends of ncp patients to develop practical and effective clinical diagnosis and treatment schemes and provide guarantee for the rapid control of the epidemic.

Eligibility criteria:
inclusion criteria: * patients confirmed with novel coronavirus pneumonia. the diagnostic criteria refer to "pneumonitis diagnosis and treatment scheme for novel coronavirus infection (trial version 5)"; exclusion criteria: * physician judged the patient was not suitable for this clinical trial.
effectiveness of a cognitive and physical intervention to reduce head and muscle pain in working communities

Conditions: Headache Disorders; Headache; Neck Pain; Shoulder Pain

Summary: the primary purpose of this study is to evaluate the effectiveness of a workplace cognitive and physical program (intervention), in reducing the frequency of head and neck pain

many studies have been performed to assess the efficacy of non invasive physical interventions in the treatment of different types of headache and cervical pain. however the evidence on their effectiveness is still limited and the results of recent studies are conflicting. the primary objective of this study is to evaluate the effectiveness of a workplace cognitive and physical programme (intervention) in reducing the frequency of pain involving the head and neck area. the intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce parafunction and hyperfunction of the craniofacial and cervical muscles during the day. comparison(s): group of employees that will receive a cognitive/physical programme (intervention), compared to a similar group of employees that will not receive the intervention (controls); (frequency of headache and neck and shoulder pain).

Eligibility criteria:
inclusion criteria: * subjects employed at the municipality of turin ( registry-tax office) from the 1th january 2005 that will give informed consent before starting the study. exclusion criteria: - because of the pragmatic design, no exclusion criteria are required for this study

Keywords: behavior therapy relaxation techniques cognitive therapy exercise movement techniques
reducing sedentary behaviour in young adults at risk of diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: excessive periods of time spent sitting may be a risk factor for diabetes. current lifestyles encourage large amounts of sitting (sedentary behaviour) through increasing car use, computers, and appealing screen-based home entertainment systems. methods to help change such behaviours are now needed, particularly for those with a high risk of developing a chronic disease, such as diabetes. the investigators propose to decrease sedentary behaviour in a multi-ethnic group of young adults at risk of diabetes through an educational intervention (attending a workshop and having prompts). if successful, this could have significant public health benefits given the widespread nature of sedentary behaviour.

the rising prevalence of obesity and sedentary behaviour has lead to an epidemic of type 2 diabetes (t2dm). as the health and economic costs of t2dm continue to increase, there is an urgent need for an effective lifestyle intervention to prevent the development of t2dm. our group have previously developed successful structured education programmes: desmond improved lifestyle, depression, illness beliefs, weight and cv risk in adults with t2dm; prepare increased activity levels and reduced 2 hour glucose values in people with pre-diabetes. project stand will assess the effect of theory driven structured education, facilitated using automated technology, on sedentary behaviour and health outcomes in young adults at risk of t2dm. participants will be randomised to a control (c) or intervention (i) group, the latter given structured education, based on the prepare and desmond programmes, with the aim of reducing sedentary behaviour. the structured education programme will incorporate movement technology to facilitate participant feedback and self-monitoring.this will be the first uk trial to address sedentary behaviour change in a population of younger adults at risk of t2dm. our results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population.

Eligibility criteria:
inclusion criteria: * aged 18-30 years old * family history of t2dm or cvd (first degree relative) * bmi ≥ 25 (≥ 23 for south asians)

Keywords: sedentary behaviour diabetes structured education 18-30 years olds family history of t2dm or cvd bmi ≥ 25 (≥23 for south asians)
safety and tolerability of rtx-134 in adults with phenylketonuria

Conditions: Phenylketonurias

Summary: this study will evaluate the safety and tolerability of rtx-134 in adult patients with pku.

this is a phase 1b first-in-human trial in adult subjects with pku. the primary objective of this study is to evaluate the safety and tolerability of rtx-134 following intravenous administration of a single dose. rtx-134 consists of allogeneic human red cells expressing the avpal (anabaena variabilis phenylalanine ammonia lyase) gene inside the cell. the trial is designed to determine a preliminary dose and inform a dosing schedule that is deemed safe, tolerable, and potentially effective. four dose levels are planned, additional dose levels may be explored. following administration, subjects will be monitored until 28 days after last detection of rtx-134. detection of rtx-134 will be evaluated using multiple pharmacokinetic (pk) and pharmacodynamic (pd) assessments including measurement of trans-cinnamic acid (tca).

Eligibility criteria:
inclusion criteria 1. age 18 years or older with: 1. a clinical diagnosis of pku, and 2. average blood phenylalanine level ≥ 600 µmol/l based on 2 assessments up to 3 weeks apart during the 6-month period before day 0 (per available data) 2. stable diet, including medical formula 3. must be a man or a woman not of childbearing potential and agree to use adequate contraception throughout and for one year following study participation. 4. adequate organ function 5. negative antibody detection on type and screen and no evidence of clinical hemolysis exclusion criteria 1. known hypersensitivity to any component of study treatment 2. prior treatment with pegaliase 3. start of sapropterin dihydrochloride within 3 weeks of study dosing 4. use of an investigational agent within 28 days of study dosing 5. concurrent participation in an interventional trial involving ongoing treatment, including placebo. 6. infections requiring antimicrobial treatment within 7 days of study dosing 7. chronic infections, such as hiv, hepatitis b, or untreated hepatitis c 8. conditions that may alter survival of red blood cells, (e.g., autoimmune diseases, splenectomy, etc) 9. pregnant or breastfeeding
peer support groups for families with an infant in the nicu

Conditions: Anxiety; Stress

Summary: the goal of this observational study is to learn the impact of race, ethnicity, and language matched peer support groups on parental stress, anxiety, and sense of belonging for families who have or have had an infant hospitalized in the neonatal intensive care unit (nicu). the main questions aim to answer: do race, ethnicity, and language matched peer support groups decrease parental stress and anxiety and improve sense of belonging of parents while their baby is hospitalized in the nicu? and, are there any changes that should be made to the format of the peer support group sessions? participants will be invited to attend a peer support group that is matched for race, ethnicity, and language. participants will have the option of filling out a survey on stress, anxiety, and sense of belonging before and after the peer group session. additionally, participants will have the option of filling out a satisfaction survey after the peer group session.

the study will be observational research wherein participants who want to attend a peer support group, will have the option of filling out surveys before and after peer support group attendance. surveys are voluntary and the only way of assessing the behavioral outcome (impact on parental stress, anxiety, and sense of belonging); families can attend the peer support groups even if the family member does not want to participate in the survey.

Eligibility criteria:
inclusion criteria: * parental or guardian self-identified as black, african american, african, latino, hispanic, chicano * parent or guardian of infant that was or is admitted to oregon health \& science university, randall children's hospital, or providence health nicu in portland, or exclusion criteria: * parent or guardian age less than 18 years old * preferred language other than english or spanish (including if preferred communication is sign language)

Keywords: parental stress parental anxiety nicu peer support
pathophysiology and prevention of perioperative myocardial injury: a prospective randomized controlled trial

Conditions: Coronary Artery Disease,

Summary: working hypothesis and aims: 1) to explore the pathophysiology of postoperative troponin elevations and 2) whether ranolazine, a new anti-ischemic drug that has no effect on blood pressure or heart rate, prevents postoperative myocardial injury.

high-risk patients undergoing non cardiac surgery will be randomized to receive either ranolazine or placebo perioperatively and troponin will be measured on the first 3 days after surgery.

Eligibility criteria:
inclusion criteria: - all patients age 18 and above, undergoing major surgery that require at least 24 hours (overnight) stay in the post anesthesia care unit (pacu) or intensive care unit (icu), and who either have known history of cad or at least 3 of the following revised cardiac risk index (rcri) criteria29f17: 1) high-risk type of surgery, 2) history of ischemic heart disease, 3) history of congestive heart failure, 4) history of cerebrovascular disease, 5) diabetes mellitus, 6) renal failure (creatinine \> 2mg/ml). exclusion criteria: * pregnancy, lv ejection fraction ≤35%, patients with severe valvular disease, patients with poor echocardiographic images, patients who cannot swallow the pill after surgery, refusal to participate
use of qtrac technique to measure axonal excitability in anti-mag neuropathy

Conditions: Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy)

Summary: the qtrac method is an electrophysiological technique that assesses peripheral nerve axonal excitability, using computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve. because of its high sensitivity to small changes in axonal excitability, qtrac may help improve the follow-up of patients suffering from peripheral neuropathy caused by anti-myelin-associated-glycoprotein antibodies (anti-mag neuropathy), as axonal excitability is early affected in this disease. the main aim of the study is to compare qtrac results in anti-mag neuropathy patients, with qtrac results in healthy persons (matched for sex and age). a secondary aim is to determine whether or not the disease's clinical severity (measured by quantitative clinical scores) is correlated with the results of the qtrac and could be predicted by a model based on the several parameters measured in the qtrac exploration. 100 anti-mag neuropathy patients will undergo a qtrac exploration and a thorough neurological examination with clinical scoring. the results will be compared with data (matched by sex and age) from the reference database on healthy subjects, that is provided with the qtrac software. the investigators expect to prove that qtrac results are modified in anti-mag neuropathy patients, and that the clinical severity of the disease can be predicted by a combination of qtrac-measured parameters.


Eligibility criteria:
inclusion criteria: * anti-mag neuropathy (peripheral neuropathy and igm monoclonal gammopathy with anti-mag activity superior to 1000 btu) exclusion criteria: * current treatment with a medication that modifies peripheral nerve excitability (e.g. anticonvulsivants)

Keywords: axonal excitability neuropathy qtrac anti-mag electrophysiology
randomized trial comparing 3 routes of delivering lorazepam to children.

Conditions: Status Epilepticus; Convulsions

Summary: this study aims to address the hypothesis that lorazepam (an anticonvulsant) is as effective when given via the intranasal or buccal route as the intravenous route in terminating convulsions in children.

convulsions are common in children. prompt treatment with an effective anticonvulsant reduces longterm morbidity and mortality. the use of intravenous lorazepam as first line therapy in acute childhood convulsions where venous access has been obtained is widely accepted in developed countries. however, intravenous access can be a problem out of hospital or in small children. benzodiazepines such as lorazepam have long been the mainstay of first line therapy for acute convulsions but there is insufficient clinical evidence as to the optimal mode of administration when venous access has failed. lorazepam can be given via the intranasal and buccal route offering the potential to be as effective as intravenous lorazepam whilst being easier to administer and avoiding the need for intravenous cannulation. to date there are no large published studies that have evaluated the efficacy and safety of intranasal or buccal lorazepam compared to intravenous lorazepam in the treatment of acute convulsions. in this study we wish to address the urgent need to obtain randomized controlled data in treating acute convulsions in children using a drug and delivery system that is safe, effective and easy to use in our setting.

Eligibility criteria:
inclusion criteria: children with acute generalized seizures, continuing for a minimum of 5 minutes, who have not received any anti-convulsant therapy within 1 hour of presentation. exclusion criteria: children who have received anticonvulsant treatment within 1 hour prior to assessment. any child whose seizures cease following correction of hypoglycaemia. children with a known adverse reaction to lorazepam.

Keywords: intranasal buccal lorazepam paediatric convulsions