Kornimate/medical-research-clean huggingface dataset:
ramelteon for insomnia comorbid with asthma

Conditions: Insomnia; Asthma

Summary: this trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.

subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.

Eligibility criteria:
inclusion criteria: * ages 18 - 60 with both insomnia and asthma. * insomnia: * a complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early or sleep that is chronically nonrestorative or poor in quality, * the sleep difficulty occurs despite adequate opportunity and circumstances for sleep, and * at least one form of daytime impairment related to the nighttime sleep difficulty must be present. the sleep complaint should be present on most days for at least 3 months. * additional inclusion criteria include: a subjective tst \ 45 min per night; a mean lps \>20 min over 2 consecutive nights by polysomnography (neither night could have been \ 10 (based on 0-4 scale). lps is defined as amount of time to the first 10 minutes of continuous sleep. * asthma will be diagnosed based on suggestive clinical history and either * airway hyperresponsiveness indicated by a 20% or greater decrease in fev1 in response to inhalation of methacholine at 8 mg/ml or less * bronchodilator-responsive expiratory airflow limitation (if fev1 \< 70% of predicted value or \< 1.5 l, improving ≥200 ml and 12% in response to 180 µg of albuterol aerosol). in addition to the above criteria, patients should have well-controlled asthma as evidenced by acq score \< 1.5. exclusion criteria: * primary sleep pathology, other than insomnia as assessed by sleep history and confirmed by polysomnography to exclude significant sleep apnea (rdi \> 15), periodic leg movements (movement arousal index \> 15), rem behavior disorder; or circadian sleep-wake disorders * history of cognitive or other neurological disorders; * history of dsm-iv criteria for any major psychiatric disorder, including mania or alcohol or substance abuse; * depressive symptoms as assessed by the ces-d. subjects with a score of 22 or greater indicates that the person may be suffering from a major depression and therefore, will be referred to their physician; * unstable or serious medical conditions; * current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally); * shift work or other types of self imposed irregular sleep schedules; * obesity (bmi \> 35 kg/m2); or * pregnancy or desire to become pregnant during the study.
the effect of acupoint application on postoperative ileus

Conditions: Postoperative Ileus

Summary: this study aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.

postoperative ileus (poi) is a common disorder of gastrointestinal motility characterized by abdominal distension, nausea, vomiting and delayed passage of flatus or stool, which develops after every abdominal surgical procedure. poi increases risk of developing postoperative complications, decreases the bed turnover rate and prolongs the average duration of hospitalization, increasing the expense of both patients and hospitals. although the pathophysiological mechanism of poi remains unclear, recent researches suggests the inflammatory responses after surgery might be responsible for the gastrointestinal motility disorder. acupoint application is a traditional chinese intervention which has been used in treating gastrointestinal motility disorder resulted from other causes. in this study, we aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.

Eligibility criteria:
inclusion criteria: * 1. patients are scheduled to undergo elective abdominal surgery; * 2. patients age between 20 to 80 years old; * 3. umbilical skin condition is good; * 4. written informed consent provided to participate in the study. exclusion criteria: * 1.patients don't match the inclusion criteria; * 2. patients with severe comorbidity such as cardiac disease, liver disease, pulmonary disease or renal disease ; * 3.patients with mental disorder; * 4. patients have gastrointestinal mobility disorder resulted from clear causes, such as ankylenteron, ascites, etc; * 5. patients received ostomy operation, such as jejunostomy; * 6.patients who have history of abdominal surgery or history of bowel obstruction; * 7. patients who receive other treatments to improve the gastrointestinal mobility or/and to relieve poi related symptoms , such as gastrointestinal prokinetic drugs, enema, etc. * 8. patients who are allergic to the acupoint applicaton; * 9.patients who are unsuitable for study inclusion as determined by the investigator. (eg: patients with severe operation related complications)

Keywords: postoperative ileus acupoint eras chinese medicine
comparative evaluation of functional results and survival rate of peroneus longus tendon - plt and hamstring tendon - ht used for reconstruction of the anterior cruciate ligament.

Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Knee Injuries; Knee Ligament Injury

Summary: comparative evaluation of functional results and survival rate of peroneus longus tendon - plt and hamstring tendon - ht used for reconstruction of the anterior cruciate ligament.

comparison of treatment results - survival and reconstruction of autographs and functional results of the knee joint, and functional results of the ankle joint, obtained in the study groups operated using two methods: a- the use of a long fibular tendon autograft taken from the lower leg of the same limb and used as a graft for acl reconstruction (anterior cruciate ligament) of the knee joint; b- the use of hamstring muscle tendon autograft (semitendonus and slender muscle) taken from the lower leg of the same limb and used as a graft for acl reconstruction (anterior cruciate ligament) of the knee joint.

Eligibility criteria:
inclusion criteria: * age 18-65 years; * surgery for acl damage to the knee joint; * arthroscopic surgery; * no prior knee surgical interventions; * no additional pathologies in this anatomical area; * patient informed consent to participate in research. exclusion criteria: * age under 18 or over 65; * previous surgical interventions in the examined anatomical area; * additional pathologies in this area identified as part of preoperative diagnostics; * damage to the second knee joint; * failure to comply with the rigor of the same rehabilitation treatment protocol.

Keywords: injuries rupture tear acl reconstruction techniques
observational study of ascvd risks of type 2 diabetes in east china

Conditions: Type 2 Diabetes Mellitus; Arteriosclerotic Cardiovascular Disease; Liraglutide

Summary: the aim of this study is to screen patients with type 2 diabetes with high risk of cardiovascular disease, and intervene with or without glucagon like peptide-1 receptor agonists.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c ≥7.0% * prior cvd cohort: age ≥50 and ≥1 of the following criteria. * prior mi * prior stroke or tia * prior coronary, carotid or peripheral arterial revascularization * n50% stenosis of coronary, carotid, or lower extremity arteries * history of symptomatic chd documented by positive exercise stress test or any cardiac imaging or unstable angina with ecg changes * asymptomatic cardiac ischemia documented by positive nuclear imaging test, exercise test or dobutamine stress echo * chronic heart failure nyha class ii-iii * chronic renal failure, egfr \<60 ml/min per 1.73m2 mdrd egfr \<60 ml/min per cockcroft-gault formula * no prior cvd group: age ≥60 y and ≥1 of the following criteria. * microalbuminuria or proteinuria * hypertension and left ventricular hypertrophy by ecg or imaging * left ventricular systolic or diastolic dysfunction by imaging * ankle-brachial index b0.9 exclusion criteria: * type 1 diabetes * other type diabetes * calcitonin ≥50 ng/l * use of a glp-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any dpp-4 inhibitor within the 3 months prior to screening * use of insulin other than human nph insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. shortterm use of other insulin during this period in connection with intercurrent illness is allowed, at investigators discretion * acute decompensation of glycemic control * an acute coronary or cerebrovascular event in the previous 14 d * currently planned coronary, carotid, or peripheral artery revascularization * chronic heart failure (nyha class iv) * current continuous renal replacement therapy * end-stage liver disease * history of solid organ transplant or awaiting solid organ transplant * malignant neoplasm * family or personal history of multiple endocrine neoplasia type 2 (men2) or familial medullary thyroid carcinoma (fmtc) * personal history of non-familial medullary thyroid carcinoma
validation and application of a multi-dimentional frailty assessment tool-cohort intervention and follow up

Conditions: Frailty; Fall; Sarcopenia

Summary: we aim to (1) use a multifaceted, frailty assessment model. (2) use randomized controlled trials to deal with and intervene with cross-field, multi-faceted and intelligent remote management strategies for the elderly with different degrees of frailty, to further observe functional changes and analyze the probability of adverse prognosis such as falls, hospitalization, and death in the future

background: frailty is a common problem among the elderly, and it is closely related to their own age, chronic diseases, physical function, and nutritional status. the higher the incidence, the higher the age. frailty is also associated with many adverse outcomes, such as falls, disability and even mortality. at present, there is no ideal treatment for frailty. it is best to start with prevention and take precautions against various frailty factors in advance. there are two types of frailty assessments in this study. the clinical frailty scale is a single observational assessment method, which can roughly know your frailty degree. frailty indicators are further combined with questionnaires and instrumental measurements, which can be subdivided to explore different weaknesses such as subjective frailty, objective frailty, sarcopenia, osteoporosis risk, and fall risk for analysis. objects: elderly people in the community (over 65 years old) who seek medical treatment in the geriatrics department of national taiwan university hospital, and who are willing to accept the frailty index test are eligible for admission. we expect to enroll about 216 cases from 2023.2.1 to 2024.12.31 with intervene and follow up for 1 year. method:. all the elders were given questionnaires and instruments to measure various frailty indicators, such as walking speed, standing up and walking test, muscle mass index, grip strength, 5 times of sitting and standing speed, and various physiological indicators such as blood oxygen, body fat, etc. the subjects will be randomly assigned to the intervention group or the control group. the control group will receive routine outpatient care. the intervention group will receive multi-faceted frailty prevention and treatment programs such as physical exercises, nutritional advice, cognitive training, and drug education. after that, the prognosis will be tracked by telephone every 3 months, and the self-evaluation questionnaire and the measurement of frailty indicators will be carried out at the 6th and 12th months. in order to observe the changes in the prognosis and frailty indicators of the two groups in one year.

Eligibility criteria:
inclusion criteria: * adults aged greater than 65 years in outpatient department exclusion criteria: * with dementia * with active cancer and those unable to operate or follow measuring instructions. * individuals with pacemakers or metal implants were excluded because those devices may interfere with measurement of body composition using the bioelectrical impedance analysis (bia) technique
gemcitabine, oxaliplatin in combination with bevacizumab in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with hepatocellular carcinoma.

* treatment is given in cycles, each cycle (except for cycle 1) is 4 weeks long. cycle 1 is only 2 weeks long. * during cycle one only, bevacizumab will be given intravenously on day one. two weeks after receiving bevacizumab, the patient will return to the clinic for treatment with all 3 study drugs. * during cycle 2 and every cycle thereafter patients will receive; bevacizumab intravenously on day one and day 15; gemcitabine intravenously on day 2 and day 16; oxaliplatin intravenously on day 2 and day 16. * the following evaluations will be conducted on day 1 and day 15 of each cycle (once every 2 weeks): physical examination, vital signs, medical history, blood tests and urine tests. * tumor measurements done by ct and/or mri will be repeated at the end of cycle 3 and every 2 cycles thereafter. * dynamic contrast-enhanced magnetic resonance imaging (dce-mri) of the liver and perfusions ct scans will also be done on days 10-12 following bevacizumab treatment during cycle 1, and the perfusion ct will be repeated at the end of cycle 3. * once study treatment is stopped the following evaluations will be performed: physical exam, vital signs, blood work, urine tests, ct scan of chest, abdomen and pelvis, and tumor measurements by ct or mri scans. * follow-up will consist of physical examinations and blood tests every 6 months. * patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.

Eligibility criteria:
inclusion criteria: * unresectable or metastatic hepatocellular carcinoma * measurable tumors * adequate hepatic function: total bilirubin \< 3.0mg/dl; ast \< 7x uln * adequate bone marrow function: anc \> 1,000/mm3; platelets \> 75,000/mm3 * inr \< 1.5 for those who are not on anticoagulation * up to two prior chemotherapy regimens for hepatocellular carcinoma * 18 years of age or older * ecog performance status of 0-1 * life expectancy of \> 12 weeks exclusion criteria: * clinically apparent central nervous system metastases or carcinomatous meningitis * uncontrolled serious medical or psychiatric illness * pregnant or lactating women * current or recent (within 4 weeks of first study infusion) participation in experimental study drug * uncontrolled hypertension * significant proteinuria * serious, non-healing wound, ulcer, or bone fracture * evidence of bleeding diathesis or coagulopathy

Keywords: unresectable hepatocellular carcinoma metastatic hepatocellular carcinoma gemcitabine oxaliplatin bevacizumab avastin
long-term safety and tolerability of idebenone in friedreich's ataxia patients (miconos extension)

Conditions: Freidreich's Ataxia

Summary: this is an extension study of the miconos main randomised placebo-controlled trial (nct00905268), and open to those patients completing the main study. the scientific aim of this extension study is to monitor safety and tolerability of idebenone over two years in patients with friedreich's ataxia.


Eligibility criteria:
inclusion criteria: * completion of 52 weeks in study snt-iii-001 * body weight ≥ 25 kg * negative urine pregnancy test * eligibility to participate in the present extension study as confirmed by investigator exclusion criteria: * safety or tolerability issues arising during the course of snt-iii-001 which in the opinion of the investigator preclude further treatment with idebenone * clinically significant abnormalities of haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of sgot, sgpt or creatinine * parallel participation in another clinical drug trial * pregnancy or breast-feeding * abuse of drugs or alcohol

Keywords: frda idebenone frda disease
development of ketoacidosis during the perioperative period: an observational study 'the dkap study'

Conditions: Ketosis; Keto Acidosis; Ketoses, Metabolic; Ketosis, Diabetic; Peri-operative; Diabetes Mellitus

Summary: rationale: during perioperative period, prolonged starvation, surgical stress, acute complications (e.g. infection) and medication changes all promote ketone generation, therefore increasing the risk of ketoacidosis. at present, there is no literature concerning the ketone production in patients undergoing cardiac surgery, regardless of the diabetes status. objectives: the objectives of this study are to explore the change in blood ketone level during the perioperative period in patients with and without diabetes, to observe the incidence of perioperative ketoacidosis, and to investigate therapy and outcome of patients with perioperative ketoacidosis.

study procedures on the first day of admission, all the patients scheduled for cardiac surgery with an on-pump procedure will be asked for a consent for anonymous using of their information. patients giving permission will be screened for participation in this study, and those fulfil the inclusion/exclusion criteria will be included for further research. blood ketone will be measured with statstrip glucose/ketone meters (nova biomedical, united kingdom) using sample leftover from blood gas analysis. no extra blood draw is needed. the levels of ketones will be measured at four time points: 1. beginning of surgery; 2. the moment the cardio-pulmonary bypass machine takes over the circulation. 3. after the decoupling of the cardio-pulmonary bypass machine 4. at the end of surgery. diagnosis of ketoacidosis is based on criteria mentioned. epidemiology characteristics and perioperative variables will be extracted from electronic medical records.

Eligibility criteria:
in order to be eligible to participate in this study, a subject must meet all of the following criteria: inclusion criteria * aged eighteen years or older * scheduled for open heart surgery exclusion criteria * diagnosed with type 1 diabetes mellitus or latent auto-immune diabetes in adults * recently used sodium glucose transport co-enzyme 2 (sglt-2i's) within 2 weeks before surgery) * history of recurrent ketoacidosis (two times or more within three months) * emergency surgery * (suspected) pregnancy

Keywords: surgery ketones
left ventricular thrombus registry

Conditions: Left Ventricular Thrombus

Summary: left ventricular thrombus (lvt) is a blood clot that can develop in a poorly functioning heart. in around 1 in 6 patients who have had a heart attack or diagnosed with heart failure tend to develop blood clots in their main heart chamber. having a blot clot in the main heart chamber can lead to serious complications such as stroke. treatment for blood clots is blood thinning medications, which if taken for a prolonged period of time can result in bleeding which further complicates treatment. we hope to gather information to better understand the factors associated with blood clot formation and management in the lower left chamber of the heart. this understanding will hopefully enable us and others to improve management of this condition in the future and therefore help the wider population. as part of this study, bloods and scan results will be recorded and we will complete a short quality of life questionnaire. when participants come in for routine mri scan, we may capture additional images for further research analysis. a sample of blood no more than one tablespoon will be collected for research analysis at the same time as routine blood test. this will occur at baseline and at around 6 months. at 12 months we will repeat the quality of life questionnaire and collect final data.


Eligibility criteria:
inclusion criteria: * patients with lv thrombus or; * patients at risk for developing lv thrombus (e.g severe lv dysfunction, lv aneurysm, mi. exclusion criteria: * age \< 18 years * unable to consent
treatment of alzheimer's and dementia with the metabolism, infections, nutrition, drug elimination (mind) protocol

Conditions: Alzheimer's Disease; Dementia

Summary: treating with measures that may improve metabolic functioning of neurons in an integrated protocol

most organ failure results in modest drops in function until over 50% of function is lost. at a certain point, even modest drops in physiologic activity result in dramatic drops in clinical function. though less homogeneous than in other organs, clinical experience and the literature suggests a similar process occurs in the brain. the hypothesis is that by using an integrated protocol to, essentially, "tune up" neuronal function, a 5-10 % improvement in metabolic functioning may translate to significant improvement in clinical functioning. this tune-up will include "mind": m- metabolism-- optimizing hormonal function i- infections-- looking for and eliminating n- nutritional and herbal support d- drugs- weaning subjects off unneeded medications

Eligibility criteria:
inclusion criteria: * a diagnosis of alzheimer's and/or dementia with an mmse score over 12 or being ambulatory and able to travel outside the home with assistance. * must have a caregiver living with them. exclusion criteria: * overt progressive and severe causes of secondary dementia such as metastatic brain cancers, or severe overt infectious encephalopathies or severe autoimmune illness. * also, severe life threatening illnesses which would make them unlikely to be alive after 6-12 months
role of abus as an alternative to breast mri in assessing response to neoadjuvant chemotherapy

Conditions: Breast Cancer

Summary: some women who have been diagnosed with a breast cancer will require chemotherapy as part of their treatment. the chemotherapy can be given before breast surgery - neoadjuvant chemotherapy or after breast surgery - adjuvant chemotherapy. whether chemotherapy is given before or after does not affect the clinical outcomes for the woman - ie there is no disadvantage to the woman. due to the fact that giving chemotherapy before has no disadvantages, many of the oncologists like to give the chemotherapy before because they can see if the breast cancer is responding. they are able to do this by using imaging. the best imaging test is breast mri. ultrasound can be used but studies have shown that it is not as good. however, whole breast ultrasound (abus) provides 3 dimensional information similar to breast mri and the purpose of our study is to see if abus performs similar to breast mri in being able to see if a tumour is responding to the chemotherapy. the breast mri requires women to lie facing down and takes about 20mins. it involves an injection of contrast called gadolinium via a cannula. abus involves scanning the whole breast with the patient lying on their back and takes 10mins. there is no injection of contrast. mri is an expensive test and often there is limited access to the scanner and so patients may have to wait for an appointment. abus because it is an automated process for obtaining the images can be performed in the breast unit in a timely manner without the issue of competing demands. all women who agree to take part in the study will have both the breast mri - standard or care and the abus.


Eligibility criteria:
inclusion criteria: 1. all female participants eligible for neoadjuvant chemotherapy and planning surgical treatment 2. able to give informed consent exclusion criteria: 1. all female particpants having neoadjuvant chemotherapy as palliative treatment with no surgery planned 2. unable to provide informed consent 3. unable to have breast mri scan due to clautrophobia or allergy to gadolineum