Kornimate/medical-research-clean huggingface dataset:
stereotactic ablative radiotherapy for oligo-progressive disease refractory to systemic therapy in metastatic cancer

Conditions: Head and Neck Cancer; Metastatic Cancer; Oligoprogressive

Summary: a registry-based randomized phase ii trial. a total of 46 patients with metastatic head and neck cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.


Eligibility criteria:
inclusion criteria: * age ≥18 years * biopsy proven hnscc (oropharynx, oral cavity, nasopharynx, sinonasal, larynx or hypopharynx) * metastatic hnscc, with pathological or radiological proof of metastasis * ability to provide written informed consent * eastern cooperative oncology group (ecog) performance status 0-2 * progressive disease while on systemic treatment (any line), defined as per recist criteria 1.1 on ct metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on ct. * oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. progression at the primary tumor site should be counted within the total of 5 lesions. for patients with lymph node metastases, each node is counted as one site of metastasis. * all sites of disease can, in the opinion of the investigator, be safely treated and targetable with sabr (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.) * patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible. exclusion criteria: * pregnancy or breastfeeding * any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy. * presence of spinal cord compression * metastatic disease that invades the gi tract (including esophagus, stomach, small or large bowel

Keywords: head and neck cancer metastatic cancer oligoprogression
effectiveness of calcium channel blockade for op and carbamate pesticide poisoning

Conditions: Anticholinesterase Insecticide Poisoning; Pesticide Poisoning

Summary: this study evaluates whether the addition of intravenous magnesium sulphate or nimodipine to standard therapy (supportive care plus for all patients atropine and, for op insecticide poisoned patients, pralidoxime) benefits patients after acute anticholinesterase self-poisoning with op or carbamate insecticides.


Eligibility criteria:
inclusion criteria: * patients aged 16 years or older with suspected op or carbamate insecticide self-poisoning admitted to medical wards with the cholinergic toxidrome requiring atropine. * diagnosis will be made on the basis of the cholinergic toxidrome clinical features (eg. small/pinpoint pupils, bronchorrhoea, sweating) or on the history of atropine administration with beneficial effect. the insecticide involved will be identified where possible from the history, the bottle brought in by the patient or relative, the patient/relative identifying the pesticide on a chart showing all locally available pesticides, and/or relatives sending a photo of the bottle by eg. whatsapp. * patients who ingest combination products containing op or carbamate insecticides will also be included. * inhibited blood cholinesterase activity as shown by routine clinical bedside test exclusion criteria: * children aged \<16 years. * patients who do not require atropine and have not had it prior to presentation during this episode. * normal blood cholinesterase activity * self-reported known pregnancy (as per south asian practice, no attempt will be made to formally test for pregnancy in the patients due to the issue of confidentiality in the acute care situation in these hospitals and the social consequences of an unexpected positive response) * known occupational and homicidal poisoning * past medical history of severely impaired renal function * hypersensitivity to magnesium and its salts * patients who have had a myocardial infarction or unstable angina in the last month * patients with traumatic subarachnoid haemorrhage * lack of informed consent (unaccompanied unconscious patients and others)
providing rapid out of hospital acute cardiovascular treatment (proact)

Conditions: NSTEMI

Summary: the purpose of this study is to determine if early diagnosis and risk stratification acquired through pre-hospital clinical assessment, 12-lead electrocardiogram and point of care biomarkers will facilitate enhanced triage and treatment in patients with presumed non-st elevation acute coronary syndromes (nstemi).

utilizing the platform of pre-hospital stemi research and clinical experience developed over the past decade; we now intend to investigate how best to achieve timely diagnosis and risk stratification of patients that present to pre-hospital emergency medical services with symptoms suspicious for acute nstemi through utilization of systematic clinical assessment, pre-hospital 12 lead electrocardiogram and point of care measurement of biomarkers. additionally, where deemed appropriate these patients will be enrolled in a clinical chest pain protocol utilizing the pre-hospital biomarkers. we hypothesize that establishing a pre-hospital diagnosis in this condition may facilitate efficient triage and -as appropriate- in-hospital disposition. additionally, the enhanced pre-hospital assessment of this population will facilitate appropriate timely disposition of those patients not found to have acute cardiovascular disease. these processes will facilitate decanting the frequently overcrowded and under resources emergency departments.

Eligibility criteria:
inclusion criteria 1. patient that activates pre-hospital emergency medical services (ems) for symptoms of acute chest discomfort for which acute cardiovascular disease is deemed to be the most probable diagnosis by ems personnel. 2. patient is older than 30 years of age 3. patient is able to give informed consent exclusion criteria 1. patient with documented st elevation on the initial 12 lead ecg 2. patient with a prior diagnosis that is compatible with another disease i.e. severe asthma, etc. 3. patient with central nervous system symptoms or syncope 4. patient with cardiac arrest, ventricular tachycardia or atrial fibrillation with heart rate \> 110 bpm

Keywords: nstemi point of care biomarkers
tmc435-tidp16-c121: a study comparing 2 tablet formulations of tmc435 to an established capsule formulation and evaluating the effect of food on blood levels of tmc435

Conditions: Hepatitis C Virus

Summary: the purpose of this study is to compare the levels of tmc435 in the blood circulation after intake of 2 tablet formulations with the level of tmc435 in the blood circulation after intake of a capsule formulation. the trial will also evaluate levels of tmc435 in the blood circulation after intake of the capsule formulation fasted or following a meal.

this is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention), single dose, crossover (volunteers will receive different interventions sequentially during the trial) study in healthy volunteers. the trial will evaluate the levels of tmc435 in the blood circulation after a single dose of 150 mg tmc435 as a capsule formulation taken fasted (treatment a) and following a meal (treatment b). in addition, the study will evaluate the levels of tmc435 in the blood circulation after intake of a single dose of 150 mg tmc435 as 2 different tablet formulations (treatments c and d). there will be a 14-day washout period between treatments and a 4-5 week follow-up at the end. each volunteer will receive all four treatments. the main focus of the trial is the pharmacokinetic characteristics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of the different formulations. this evaluation requires multiple blood samples from day 1 through 72 hours after dosing. safety assessments (lab work, blood pressure, pulse and electrocardiogram) will follow a different schedule and are measured on day -1 (day prior to taking first dose of drug), day 1 (day of first dosing) and/or day 4 of each treatment period, and 4 weeks after the last treatment. each volunteer will receive 4 treatments, about 14 days apart from each other. each treatment consists of one single dose of 150 mg tmc435.

Eligibility criteria:
inclusion criteria: * non-smoker for at least 3 months * body mass index of 18.0 to 30.0 kg/m2 * healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram exclusion criteria: * infection with hepatitis a, b or c virus * infection with the human immunodeficiency virus (hiv) * women who are pregnant or breastfeeding * history of, or any current medical condition which could impact the safety of the participant in the study

Keywords: tmc435-tidp16-c121 tmc435-c121 tmc435 tmc435350 protease inhibitor hcv hepatitis c
the coma family program: a skills-based resiliency program for caregivers of patients with severe acute brain injuries

Conditions: Coma; Emotional Distress

Summary: the purpose of this study is to pilot a psychosocial skills-based intervention for caregivers of patients with severe acute brain injuries. the data the investigators gather in this study will be used to further refine our coma-f intervention.

the goal of this study is to refine our proposed intervention (coma-f) through an open pilot. the investigators will deliver an open pilot of the intervention (n=15 caregivers) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments. the open pilot will take place at the massachusetts general hospital, university of north carolina school of medicine, and university of maryland school of medicine neurological intensive care units (nicus) or step-down units using our established methodology successfully implemented during our previous r21 of our recovering together study. study clinicians will deliver 6, 30 minute sessions of the intervention (at bedside or on zoom, depending on participant preference). all participants will complete measures at baseline, and after completion of program (6 weeks). they will also complete measures of emotional distress weekly. at the completion of the program, participants will engage in a 5-10 minute exit interview where they will provide feedback of the intervention.

Eligibility criteria:
inclusion criteria: eligible caregivers must be caregivers of patients considered to have severe acute brain injury and be unable to communicate with their loved one or clinical team due to their incapacitated nature. caregivers must meet the following inclusion criteria: 1. age 18 or older 2. english-speaking 3. confirmed by the primary clinical team as the primary caregiver for a patient who: a. is age 18 or older; b. has been admitted to the icu with a severe acute brain injury: i. ischemic stroke ii. intracerebral hemorrhage iii. subarachnoid hemorrhage iv. traumatic brain injury v. hypoxic-ischemic encephalopathy; c. in the judgment of the medical team, has had a glasgow coma scale score below 9 while not intubated or an inability to following meaningful commands while intubated at any point during his or her hospitalization course for greater than 24 consecutive hours, felt to be due to the brain injury itself and not a confounding factor (i.e., sedation, seizures, etc.); d. is still alive in the icu at the time that the clinical team approaches the primary caregiver about possible recruitment; e. has a prognosis for survival of greater than 3 months and does not have a concurrent diagnosis of a terminal illness or injury, as judged by the clinical team. exclusion criteria: patient has terminal diagnosis caregiver has: * lack of access to internet and/or a device with a camera * current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use

Keywords: severe acute brain injury emotional distress
nutritional assessment of hospitalized patients with covid-19

Conditions: SARS-CoV; Nutrition Disorders

Summary: the nutritional consequences of the infection by the sars-cov-2 are as follows: * a severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as well as an increase in energy expenditure related to ventilatory work; nutritional requirements (calories and protein) are therefore increased. * food intake is often reduced by several factors: anorexia secondary to infection, respiratory discomfort, anosmia, ageusia, obesity, stress, confinement, organizational problems limiting meal assistance. then, it is important to asses the nutritional status of covid patients hospitalized in conventional covid units (excluding intensive care).


Eligibility criteria:
inclusion criteria: * patient on conventional hospitalization (duration less than 72 hours) * age \> 18 years old * covid 19 diagnosed by real time polymerase chain reaction (rt-pcr) * patient agreed to participate in the study * patient affiliated to french social security exclusion criteria: * patient hospitalized in intensive care units during more than 72 hours

Keywords: covid-19 nutrition disorders
cardiac screening in survivors of hodgkin's disease treated with mediastinal irradiation

Conditions: Hodgkin's Disease

Summary: the main purpose of this study is to determine if it is possible to put into practice a cardiac screening program for survivors of hodgkin's disease. in this study, we would also like to screen for cardiac risk factors that can be modified either through life-style changes or medications, to uncover significant abnormal heart findings in which treatments may be needed, and to see if there is a link between cardiac health and quality of life.

* on the day of the patient's scheduled follow-up visit with their oncologist, additional blood work will be obtained and the patient will fill out questionnaires concerning their general health and assessing quality of life. * a separate cardiology visit with a preventative cardiologist will be performed. at this visit, the patient will undergo a stress echocardiogram. * a stress echocardiogram is made up of three parts: resting echo study, stress test and repeat echo while the heart is still beating fast. * a resting echo provides the baseline examination and demonstrates the size and function of various chambers of the heart. * the stress test involves exercise using a treadmill or a stationary bike. in patients who are unable to complete a high level of exercise due to physical limitations, stress to the heart is provided by a pharmaceutical or chemical stimulation to the heart. exercise is started at a slower, warm-up speed and then increased every 3 minutes. exercise is abruptly stopped once the patient exceeds 85% of the target rate. ekg recordings are made every minute of exercise and then again after exercise is stopped. blood pressure is recorded at three minute intervals during exercise and then again at rest. * immediately after exercise is stopped, the patient will undergo a repeat echocardiogram. * if no cardiac abnormalities are detected, the screening tests will be repeated every 3 years, if the patient is less than 10 years out from their initial treatment. if the patient is more than 10 years from initial treatment, then the tests will be repeated at approximately 18 months from the initial screening and once more at the end of the third year.

Eligibility criteria:
inclusion criteria: * patients treated at brigham and women's hospital or dana-farber cancer institute for hodgkin's disease with mediastinal irradiation * age \> or = to 15 years of age * five years or longer after initial treatment * relapse-free interval of \> 1 year exclusion criteria: * patients treated for hodgkin's disease outside of brigham and women's hospital or dana-farber cancer institute * current age \< 15 years of age * less than 5 years out from initial treatment * relapses within 1 year

Keywords: cardiac screening cardiac stress test echocardiogram
helium-hyperoxia and 6mwt distance in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: we assessed the effect of altering inspired gas on the 6mwt distance in copd. we hypothesized that heo2 would improve walking distance and reduce shortness of breath compared to both ra and o2, and potentially improve quality of life for copd patients.

we hypothesized that inspiring helium-hyperoxia (heo2) would significantly improve 6-minute walking test (6mwt) distance in chronic obstructive pulmonary disease (copd) subjects. this was a blinded, randomized crossover study. at visit 1 we assessed pulmonary function, exercise capacity and 6mwt distance. visits 2 and 3 consisted of four 6mwt with different inspired gases: room air by mask (ra), 100% o2 by mask (mask o2), 100% o2 by nasal prongs (nasal o2), and 70% he/30% o2 by mask (heo2). walking distance, shortness of breath, leg fatigue, o2 saturation and heart rate (hr) were assessed

Eligibility criteria:
inclusion criteria: * exertional dyspnea * activity limitation * copd exclusion criteria: * recent exacerbation (\< 4 wks) * supplemental o2 * significant cardiovascular/musculoskeletal abnormalities

Keywords: 6-minute walk test copd helium-hyperoxia exercise chronic obstructive pulmonary disease (copd)
subcutaneous aspart insulin to treat diabetic ketoacidosis (dka) and beta-hydroxybutyrate testing in dka

Conditions: Diabetic Ketoacidosis

Summary: the purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.


Eligibility criteria:
inclusion criteria: age 18 or older * venous ph \< 7.3 or arterial \< 7.35 * at least 2 of the following 3: 1. serum hco3 \ 16 2. serum glucose \> 300 mg/dl 3. serum acetone positive exclusion criteria: * pregnant * less than age 18

Keywords: dka
clinical trial to study the safety tolerability, pharmacokinetics, food effect & pharmacodynamics of a new compound p7435 in healthy, overweight and/or obese subjects

Conditions: Healthy, Overweight and/or Obese Subjects

Summary: clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound p7435 in in healthy, overweight and/or obese subjects

* a phase i, randomized, double-blind, placebo-controlled, dose escalating study of p7435 to determine the safety, tolerability, pharmacokinetics, food effect and pharmacodynamics of single and multiple ascending doses of p7435. * subjects participating will be either healthy subjects or healthy overweight and/or obese subjects. in this study, overweight/obese are defined as subjects having a bmi of 23 kg/m2 and above. * the study will be conducted in 3 parts as follows: part a will consist of the single ascending dose (sad) study, part b will consist of the multiple ascending dose (mad) study and part c will consist of the food effect study.

Eligibility criteria:
inclusion criteria: * willingness and are able to provide a written informed consent to participate in the study. * healthy adult male subjects aged between 18 and 45 (both inclusive) years old * bmi between 19 and 23 kg/m2. overweight (bmi between 23 and 25kg/m2) and/or obese (bmi between 25 and 35 kg/m2) but otherwise healthy subjects in partb . * healthy as determined by the investigator * smoking less than 10 cigarettes per day and able to refrain from smoking during confinement. * ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, "power drinks") and grapefruit juice to admission. exclusion criteria: * employees of the sponsor or clinical sites. * female subjects. * no past or current serious diseases of any organ will be allowed. exceptions may be non-malignant skin diseases, childhood asthma and other conditions as per the investigator's discretion and discussed with the sponsor a priori. history of significant gastrointestinal disease or other significant diseases including cardiac, renal or liver impairment. * history of sleep apnea, irregular sleep/wake cycle or working in night shifts. * acute disease state * history of hypo/hyperthyroidism or repeated abnormal tsh values at screening or obesity of endocrine origin. * history of alcoholism for more than 2 years * positive serology for human immunodeficiency virus (hiv-1/2) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies. * positive findings in urine drug screen / alcohol breath test. * participation in another clinical trial within 90 days of the first drug administration. * intake of more than 8-10 cups of coffee and/or tea per day and consumption of methyl xanthine-containing beverages (tea, coffee, cola drinks, chocolate) within 48 hours prior to study. * donation of blood (i.e. 350 ml) within 90 days before day -1 of the first treatment period.

Keywords: p7435 healthy,overweight and or obese subjects single ascending dose multiple ascending dose pharmacokinetics
homa-ir as a screening test in nafld

Conditions: NAFLD

Summary: the aim of this study is to evaluate the role of homa-ir in diagnosis of nafld in patients with type 2 dm.

this study is a retrospective cohort study included 100 patients with type 2 dm from the outpatient clinic of internal medicine department at fayoum university hospital. they were divided into two equal groups according to the presence of nafld by ultrasound. all patients were subjected to history taking, clinical examination and investigations which included: alt, ast, total cholesterol, tg, fbg and fasting insulin level,homa-ir(homeostatic model assessment for insulin resistance) assessment.

Eligibility criteria:
inclusion criteria: - diabetes obesity exclusion criteria: * use of alcohol