Kornimate/medical-research-clean huggingface dataset:
emergency radiotherapy in metastatic spinal cord compression of patients with non-small cell lung cancer

Conditions: Neurological Outcome; Survival From First Diagnosis Metastatic Spinal Cord Compression to Death

Summary: acute neurological deficit in metastatic spinal cord compression is an emergency condition in radiation oncology. despite some reports about the high efficacy of radiation treatment for oncological emergencies, a standard of care is not well defined, especially the time interval of immediate rt after deficit, and neurological outcome with respect to poor survival in non-small cell lung cancer patients. the objective of this trial is to investigate neurological outcome after emergency radiotherapy in metastatic spinal cord compression of non-small cell lung cancer patients with acute neurological deficit.

subjects and recruitment 15 consecutive patients with histologically confirmed non-small cell lung cancer and bone metastases of the thoracic or lumbar segments of the vertebral column will be screened for this trial in the radiooncology department of the heidelberg university clinic. inclusion criteria are an age of 18 to 80 years, acute neurological symptom caused by metastatic spinal cord compression, no radiotherapy in this spinal area before, and written consent to participate. design and procedures this is a prospective, controlled, explorative trial to investigate the neurological outcome after emergency radiotherapy in metastatic spinal cord compression of non-small cell lung cancer patients with acute neurological deficit. rt start within 12 hours after onset of neurological symptoms. the target parameters will be measured at the start of radiotherapy (t0), and six weeks after radiotherapy (rt) (t1). the target parameters comprise the documentation and completion of the asia impairment scale (ais), and the recording of patient-specific data.

Eligibility criteria:
inclusion criteria: * inclusion criteria are an age of 18 to 80 years, acute neurological symptom caused by metastatic spinal cord compression, no rt in this spinal area before, and written consent to participate. exclusion criteria: * neurological symptom more than 12 hours before

Keywords: emergency radiotherapy mscc spine neurological outcome
a research study to look at how faster aspart works in chinese people with type 1 diabetes or type 2 diabetes

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study looks at how faster aspart reaches and stays in the blood after injection in chinese people with type 1 diabetes or type 2 diabetes, compared to the reference product called novorapid®. participants will get both faster aspart and novorapid®. the order in which participants get them is decided by chance. participants will get each study medicine once during the study meaning that they will get a total of 2 injections with study medicines. the medicine will be injected under the skin of the lower abdomen. the study will last for about 19-72 days. participants will have 5 clinic visits with the study doctor (including the one in which participants give their consent). participants will need to stay overnight for 2 of the 5 clinic visits. participants will have blood samples taken during some of the clinic visits. during the visits where participants get the study medicines, samples of their blood will be taken several times for up to 12 hours after getting the study medicine.


Eligibility criteria:
inclusion criteria: for a subject with type 1 diabetes mellitus: * male or female chinese subjects aged 18-64 years (both inclusive) at the time of signing informed consent. * type 1 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening. * treated with multiple daily insulin injections or premix insulin greater than or equal to 12 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (csii) greater than or equal to 3 months prior to the day of screening. * glycosylated haemoglobin (hba1c) less than or equal to 9.0 percent (75 mmol/mol) by central laboratory analysis. for a subject with type 2 diabetes mellitus: * male or female chinese subjects aged 18-75 years (both inclusive) at the time of signing informed consent. * type 2 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening. * treated with multiple daily insulin injections or premix insulin greater than or equal to 6 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (csii) greater than or equal to 3 months prior to the day of screening. * glycosylated haemoglobin less than or equal to 9.5 percent (80 mmol/mol) by central laboratory analysis. exclusion criteria: for a subject with type 1 diabetes mellitus or type 2 diabetes mellitus: * any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol. * surgery or trauma with significant blood loss (more than 400 ml) within the last 3 months prior to screening. * not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period.
investigation of respiratory-related tumour motion in liver cancer patients undergoing sbrt using audiovisual biofeedback

Conditions: Lung Cancer

Summary: investigation of respiratory-related tumour motion in liver cancer patients undergoing stereotactic body radiotherapy treatment (sbrt) using audiovisual (av) biofeedback.


Eligibility criteria:
inclusion criteria: * liver cancer patients, either primary hepatocellular carcinoma or liver metastases, eligible for stereotactic radiotherapy. * \>18 years old * radio-opaque markers implanted (fiducials and/or surgical clips previously implanted in the liver) * able to give written informed consent and willingness to participate and comply with the study exclusion criteria: * pregnant / lactating women
mri qsm imaging for iron overload

Conditions: Hemochromatosis; Iron Overload

Summary: the overall goal of this project is to develop and validate a novel technique for magnetic resonance imaging (mri)-based quantitative susceptibility mapping (qsm) of the abdomen, for non-invasive assessment of liver iron deposition. in this work, study team will develop and optimize advanced data acquisition and image reconstruction methods to enable qsm of the abdomen. further, investigators will determine the accuracy, repeatability, and reproducibility of abdominal qsm for iron quantification in patients with liver iron overload. excessive accumulation of iron in various organs, including the liver, which affects both adult and pediatric populations, is toxic and requires treatment aimed at reducing body iron stores. accurate assessment of liver iron concentration is critical for the detection and staging of iron overload as well as for longitudinal monitoring during treatment. in summary, this project will develop a novel mri-based qsm technique designed for the abdomen and will validate it in pediatric and adult patients with liver iron overload. upon successful validation, qsm will provide accurate, repeatable, and reproducible quantification of lic based on a fundamental property of tissue.


Eligibility criteria:
inclusion criteria: * ages 10 years or older at university of wisconsin - madison * age 5 years or older at stanford * known or suspected iron overload exclusion criteria: * patients with contraindication to mri (e.g. pacemaker, contraindicated metallic implants, etc) * pregnant or trying to become pregnant (as determined by self-report during mri safety screening) * patients requiring intravenous (iv) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the mri will be allowed to participate as long as the following criteria are met: * the subject has their own prescription for the medication. * the informed consent process is conducted prior to the self-administration of this medication * they come to the research visit with a driver

Keywords: liver iron concentration magnetic resonance imaging (mri)-based quantitative susceptibility mapping (qsm)
chronic hepatitis b virus infection in zambia

Conditions: HBV; Fibrosis, Liver; Cirrhosis, Liver; Alcoholic Hepatitis; Hepatocellular Carcinoma; Hepatitis, Delta

Summary: chronic hepatitis b virus infection is a common condition in zambia. among zambian blood donors, up to 8% are chronically infected with hbv. despite the burden, awareness of hbv is low in zambia and the ministry of health is in early stages of development of guidelines for hbv screening, treatment, and prevention. the purpose of this clinical cohort study is to characterize the clinical features of chronic hbv infection at uth and describe treatment and care outcomes. the investigators will enroll 500 adults and follow the cohort for up to 5 years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis and liver cancer.

viral hepatitis is the #7 cause of death worldwide, yet it has been neglected when compared to other infectious diseases such as hiv/aids, tuberculosis, and malaria. chronic viral hepatitis is caused by hepatitis c virus and hepatitis b virus and these infections are most common in low and middle-income countries, notably asia and sub-saharan africa. in zambia there are limited data, but from an hiv cohort, the investigators of this study described 10-12% prevalence of chronic hbv. to raise awareness of viral hepatitis in zambia and to generate local data to guide policymakers, the investigators will recruit 500 adults with chronic hbv infection and follow the cohort in an observational cohort study. in the study patients would be managed according to standards of care and no experimental or investigational drugs would be used. the investigators will carefully describe patient clinical characteristics and among those who receive drug treatment, the investigators will describe the effectiveness of that treatment in reducing liver disease.

Eligibility criteria:
inclusion criteria: * age 18 years or older * hbv-infected, defined as any single positive hbsag assay exclusion criteria: * unable or unwilling to provide informed consent * hiv-positive
esj- powder complete t&a study

Conditions: Child Nutrition Disorders; Child Malnutrition

Summary: the goal of this study is to gather data on the tolerance and acceptability of a new ons (esj-powder complete) in children currently taking ons.

the goal of this study is to demonstrate the tolerance and acceptability of the test product when consumed by children who are currently prescribed (a similar) ons. the data generated from this study will be submitted to the acbs, who will consider it for reimbursement as a food for special medical purpose (fsmp) in the uk.

Eligibility criteria:
inclusion criteria: * \>1-18 years of age * children currently prescribed and consuming oral nutritional supplements (ons) * willingness to take part in the study, and consent to the study protocol signed by parent/guardian or older child (when appropriate) exclusion criteria: participants requiring exclusive enteral tube feeding * participants on parenteral nutrition * participants with cow's milk or soy allergy or lactose intolerance * participants with galactosaemia * participants with a chronic renal or liver disease * participants who are acutely unwell
propranolol versus propranolol and clonidine in sympathetic hyperactivity after moderate traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: evaluation of the effect of propranolol versus propranolol and clonidine on decreasing sympathetic hyperactivity after moderate traumatic brain injury

measuring catecholamine levels after moderate traumatic brain injury after giving propranolol and clonidine

Eligibility criteria:
inclusion criteria: * gcs on admission between 9 and 12 age 18 up to 60 years both sexes exclusion criteria: * history of heart disease, cardiac arrhythmia and myocardial infarction diagnosis ofpreexisting brain dysfunction. impending brain herniation and craniotomy diagnosis of spinal cord injuries. diagnisis of severe liver and renal disease current use of beta blocker and or alpha agonist current using of intravenous vasopressor contraindication to enteral feeding and can not swallow pregnancy
parkinson's disease biomarker program

Conditions: Parkinson's Disease

Summary: the primary objective of this study is to obtain detailed clinical information and biologic specimens from subjects with pd toward the ultimate end of identifying a biomarker of pd. because of the inherent difficulties of using clinical outcome measures to assess disease modification, the identification of biomarkers of pd is of paramount importance. the ideal pd biomarker would be one that is easily assayed in a convenient biological sample, varies proportionally with disease severity, is abnormal during the pre-symptomatic phase of the illness, and is unaffected by drugs or other interventions used to treat pd. the existence of a sensitive biomarker with these properties would enable much more effective disease modifying research that would likely be able to take advantage of smaller and potentially shorter trials.

subjects will be asked to attend study visits every 6 months for up to 5 years of follow up. each visit will consist of patient outcomes questionnaires, neurological exams, computerized assessments of gait and balance, a video recorded motor exam, and biological specimen collection for biomarker discovery.

Eligibility criteria:
inclusion criteria: * a diagnosis of idiopathic pd meeting uk pd society brain bank criteria (step 1, step 2, and 2 items present from step 3).1 * male or female age 30 years or older at time of pd diagnosis, hoehn \& yahr (h\&y) stage i-iv. * confirmation from i-123 ioflupane spect (datscan®) of dopamine transporter deficit for de-novo, untreated patients. * clinical evidence of response to dopaminergic medication (mao-b inhibitors, dopamine agonists, levodopa, or combinations) in patients on treatment for pd. * ability to provide written informed consent in accordance with good clinical practice (gcp), international conference on harmonization (ich), and local regulations. * able to make visits to ut southwestern every 6 months for up to 5 years without undue hardship. exclusion criteria: * idiopathic pd, h\&y stage 5, as these will be unable to participate in gait assessments. * confirmed or suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases. * presence of definite dementia (moca \< 17)2. * for de-novo subjects: received any of the following drugs that might interfere with dopamine transporter spect imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of screening. * for the prospective csf cohort: current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. * for the prospective csf cohort: any condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or known clinically significant coagulopathy or thrombocytopenia. * any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.

Keywords: parkinson's disease
evaluation of the achieving depression and anxiety patient centered treatment (adapt) program

Conditions: Depression; Anxiety

Summary: depression and anxiety are increasingly common conditions for which primary care providers (pcps) serve as the initial healthcare contact for most patients. comorbid depression and anxiety result in higher costs, and treatment as usual, which is referrals to specialty psychiatric care, often contribute to delays in care. collaborative psychiatric care is an evidence-based strategy to increase mental healthcare access while reducing costs. adapt is a novel collaborative care model. by using technology-driven appointments with providers, adapt increases access to mental healthcare, and reduces member wait times. this mixed methods study will assess implementation measures of the adapt program and the components of adapt related to patient mental health improvement compared to specialty mental health care. the hypothesis is that: adapt program will have good program reach and efficacy. we will examine program implementation and maintenance. further, the study looks to uncover member and program characteristics that are associated with depression and anxiety remission and care utilization.


Eligibility criteria:
inclusion criteria: * adult outcomes questionnaire (aoq) score between 10-30 * english-speaking exclusion criteria: * high risk for suicide defined by answer to question 9 on phq-9 of 1 or more * diagnosis of bipolar disorder * diagnosis of a psychotic disorder * dementia diagnosis * active substance use disorder diagnosis * current hospice * current home-based palliative care * residing in a skilled nursing facility * residing in an assisted living facility * non-kaiser permanente member * established psychiatric care outside of kaiser permanente

Keywords: depression anxiety
expanded access program with nivolumab to treat melanoma

Conditions: Stage III (Unresectable) or Stage IV Advanced Melanoma

Summary: the purpose of this program is to provide treatment with nivolumab to subjects with stage iii or stage iv advanced melanoma.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * ecog performance status of 0-1 * histologically confirmed malignant melanoma * progressed on or after treatment with an anti-ctla4 exclusion criteria: * active brain metastases * life expectancy \<6 weeks * subjects who received prior therapy targeting t-cell costimulation or checkpoint pathways except for anti ctla-4 therapy * subjects with autoimmune disease
a study of the safety, efficacy and pharmacokinetics of glycerol phenylbutyrate in pediatric subjects under 2 years of age with urea cycle disorders

Conditions: Urea Cycle Disorder

Summary: this is an open-label study consisting of a transition period to ravicti, followed by a safety extension period for at least 6 months and up to 24 months of treatment with ravicti, depending on age at enrollment. it is designed to capture information important for evaluating safety, pharmacokinetics and efficacy in young children. subjects who are followed by or referred to the investigator for management of their ucd. subjects eligible for this study will include patients ranging from newborn to \< 2 years of age with either a diagnosed or clinically suspected ucd.

study acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * male and female subjects up to 2 years of age * signed informed consent by subject's parent/legal guardian * ucd diagnosis or suspected diagnosis of any subtype, except n-acetyl glutamate synthetase deficiency. if ucd has not been previously confirmed by genetic testing, consent must be obtained from parent/legal guardian prior to perform genetic testing. if genetic testing is inconsistent with or excludes a ucd diagnosis, the subject will be withdrawn from the study. exclusion criteria: * use of any investigational drug within 30 days of day 1 * uncontrolled infection (viral or bacterial) or any other condition known to precipitate hyperammonemic crises. once these precipitating factors are medically controlled, patients presenting in crisis are eligible. * any clinical or laboratory abnormality of grade 3 or greater severity according to the common terminology criteria for adverse events (ctcae) v4.03, except grade 3 elevations in ammonia and liver enzymes, defined as levels 5-20 times the upper limit of normal in alanine aminotransferase (alt), aspartate aminotransferase (ast), or gamma glutamyl transpeptidase (ggt) in a clinically stable subject * any clinical or laboratory abnormality or medical condition that, at the discretion of the investigator, may put the subject at increased risk by participating in this study * known hypersensitivity to phenylacetate (paa) or phenylbutyrate (pba) * liver transplantation, including hepatocellular transplant * subjects on hemodialysis at time of initiating ravicti * subjects on ravicti for ucd management * currently treated with carbaglu® (carglumic acid)

Keywords: urea cycle disorder ucd buphenyl glycerol phenylbutyrate ravicti hyperammonemia sodium phenylbutyrate gpb hpn-100
concussion active rehabilitation

Conditions: Pediatric ALL; Concussion, Mild; Concussion, Brain; Concussion, Intermediate

Summary: in this study, the investigator plans a randomized trial of active rehabilitation and standard care for acute concussion management. the investigator hypothesizes that patients with acute concussions managed with active rehabilitation will have decreased risk of prolonged concussion symptoms.

specific aims: to compare the risk of prolonged concussion symptoms (pcs) between an active rehabilitation and a standard care cohort after an acute concussion. to determine if active rehabilitation compared to routine care reduces the risk of pcs for high-risk patients. this is a prospective randomized control trial of pediatric patients in the emergency department (ed) diagnosed with an acute concussion. patients 8-18 years old with an acute concussion diagnosis will be eligible. all patients will receive pedometers to monitor their activity levels. if the patient is in the control group the patient will receive standard concussion management per the treating ed physician. patients in the active rehabilitation group will receive instructions based on the latest cdc concussion management guidelines that specify a symptom-limited progressive return to full activities. this group will be instructed to take at least 10,000 steps a day for five days on their pedometers. one to five days after the ed concussion diagnosis a trained research coordinator will call all subjects to reinforce the management plan. 28 to 32 days post ed concussion diagnosis, research assistants will contact subjects via email or phone call to complete the concussion symptoms inventory.

Eligibility criteria:
inclusion criteria: * patient diagnosed with an acute concussion within 48 hours * patient greater than 8 and less than 19 years old exclusion criteria: * major psychiatric diagnosis (bipolar disorder, major depression, does not include adhd/add) * cognitive delay * gcs \< 14 * positive findings on head ct * any patient with intracranial surgery, pathology or instrumentation (e.g. vp shunt, brain tumor etc)
evaluation of the effect of root canal preparation by tf and m-pro on post-operative pain after single visit endodontic treatment

Conditions: Acute Pulpitis

Summary: a study to comparatively evaluate the post operative pain between root canal preparation by reciprocating file (tf) and full rotation file (m-pro) in patients with single rooted teeth with acute irreversible pulpits.

teeth with symptomatic irreversible pulpitis are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment after using twisted files or m-pro files. the treatment is done in single visit. the postoperative pain is then assessed using the numerical rating scale 6,12, 24 and 48 hours post-instrumentation.

Eligibility criteria:
inclusion criteria: * patients in good health (american society of anesthesiologists class ii or higher). * patients having symptomatic irreversible pulpitis in their single rooted teeth. * age range is between 20 and 60 years. * patients who can understand numerical rating scale (nrs). * patients able to sign informed consent. exclusion criteria: * patients with positive percussion test. * patients having history of necrosis with or without apical pathosis. * patients have sinus tract or fistula extra oral or intraoral. * pregnant or mentally retarded patients. * teeth with grade 2 or 3 mobility.