Kornimate/medical-research-clean huggingface dataset:
4d ct scan versus 3d ct scan concerning cardiac dosimetry assesment for left sided breast cancers radiotherapy

Conditions: Breast Cancer; Radiation-Induced Vascular Disease; Left Anterior Descending Coronary Artery Stenosis; Radiotherapy Side Effect; Cardiac Ischemia; Left Sided Breast Cancer; LAD (Left Anterior Descending) Coronary Artery Stenosis

Summary: to establish if the cardiac radiation dose assesment is well aproximated with routine 3d ct scan compared to 4d ct experimental scan with respiratory gating (breath motion monitoring). the study population relates to left side breast cancers female patients that require a radiation therapy treatment.

as a standard of care, the postoperative breast cancers radiation therapy is generally based on a 3 dimensions ct scan that does not incorporate the breathing motion by definition. meanwhile, the patients must commonly receive the treatment in free motion breathing condition. more of that, the cardiac dose, especially the lad (left anterior descending artery) dose has been established as the main cause of radiation induced ischemic heart disease (rihd) and should be consider in the first place. in more concrete terms, the higher the lad dose is, the greater the rihd relates: arise the lad dose by 1 gy means a 7.4% higher risk to cause a rihd during the next 5 years. that being said, to determine if the cardiac dosimetry and the dose-volume histograms (specifically for the left side breast cancer treatments including or not the internal mammary artery) obtained from a 3d ct scan reflect well or not the reality (which is widely subject to the breathing motion). finally, because it has been established that a 4d ct scan can monitor the breathing motion, it seems definitely interesting to compare it with the average 3d ct scan to address this concern.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 yo 2. sex=female 3. patients diagnoses with a left side breast cancer for which a radiation therapy is indicated and confirmed in a multidisciplinary consultation meeting. 4. be able to understand and give her personal free consent, no judicial protection measure. 5. written or oral consent, in compliance with the clinical investigation rules and regulation. 6. patient affiliated with social security system 7. treatment expected to be realized in saint quentin hospital exclusion criteria: 1. patient \< 18 yo 2. pregnant women. 3. breastfeeding women. 4. consent not given 5. claustrophobia 6. incapacited subject or judicial protection measure 7. other research with exclusion period time ongoing 8. all the inclusion criteria not met

Keywords: breast cancer
perceived health after hospitalization for covid-19

Conditions: COVID-19, Post-hospitalization, Disease Impact

Summary: there are currently no precise data available on the impact of covid-19 on the daily life of patients after hospitalization. for the moment, studies have only demonstrated a strong impact of the diagnosis on the domains of quality of life explored by the mos-sf36 questionnaire and the phq-9 depression score. concerning the impact of covid-19 disease after conventional hospitalization, field reports indicate extremely intense fatigue and a major physical impact lasting several weeks


Eligibility criteria:
inclusion criteria: * adult patient * patient with a diagnosis of covid-19 confirmed by pcr and/or ct scan * patient hospitalized in a short stay unit (excluding intensive care and rehabilitation) for a covid-19 infection * patient providing oral consent to participate in the study * patient able to understand and answer the questionnaires used * patient able to answer the questions on an electronic device and to receive requests by email and/or sms * patient who has electronic equipment at home and an internet subscription allowing him/her to answer the questionnaires online exclusion criteria: * patient under guardianship, curatorship or a measure of judicial safeguard
efficacy and safety of lcz696 in comparison to olmesartan in japanese patients with essential hypertension

Conditions: Essential Hypertension

Summary: this study assessed the efficacy of lcz696 in japanese patients with essential hypertension


Eligibility criteria:
inclusion criteria: * patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy. * treated patients (using antihypertensive treatments within 4 weeks prior to visit 1) must have an mssbp ≥ 150 mmhg and \< 180 mmhg at the randomization visit (visit 201) and mssbp ≥140 mmhg \< 180 mmhg at the visit immediately proceeding visit 201 (visit 102 or 103). * untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to visit 1) must have an mssbp ≥ 150 mmhg and \< 180 mmhg at both visit 1 and visit 201. * patients must have an absolute difference of ≤15 mmhg in mssbp between visit 201 and the immediately preceding visit; exclusion criteria: * severe hypertension (msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg). * history of angioedema, drug-related or otherwise, as reported by the patient. * history or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension. * patients who previously entered a lcz696 study and had been randomized or enrolled into the active drug treatment epoch. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: essential hypertension lcz696
zaleplon in hiv patients with depression

Conditions: HIV/AIDS; Clinical Depression

Summary: in hiv positive patients with sleep onset insomnia and receiving pharmacologic treatment for comorbid depression, the proposed study aims to evaluate the impact of zaleplon on sleep measures determined by insomnia severity index (isi) and epworth sleepiness scale (ess).

an estimated \>50% of hiv positive individuals report insomnia. insomnia and other sleep disturbances negatively impact outcomes in this population by contributing to metabolic dysfunction, reducing quality of life, and impairing psychosocial functioning. additionally, in hiv depressed populations, insomnia may hinder remission from clinical depression. to date, there have been no pharmacotherapeutic studies treating insomnia in this population, emphasizing the need to determine whether known hypnotic medications work as effectively in hiv positive patients, including those with comorbid depression. non-benzodiazepine hypnotics represent an attractive pharmacotherapy for treatment of insomnia in a depressed population, as there are reduced side effects and abuse potential compared to classical benzodiazepines. consequently, an open-label study evaluating zaleplon for insomnia in hiv positive patients with comorbid depression warrants further study.

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged 18-65 years with a diagnosis of asymptomatic seropositive hiv 2. principal diagnosis of major depressive disorder or dysthymic disorder in accordance with dsm-iv criteria, and receiving pharmacologic treatment. 3. subject has obtained some subjective benefit from current antidepressant therapy and is agreeable to remain on the same medication for the course of this study 4. current symptoms of insomnia as determined by a total score of at least 2 on items 4, 5, and 6 of the ham-d, and specific complaint of sleep onset insomnia (sleep onset latency of at least 1 hour, 3 or more times per week)) 5. free of sleep medication for at least 2 weeks prior to enrollment (we will not enroll any patients who might require weaning off of sedative hypnotic medications in order to be eligible for the study) 6. ability to understand the requirements of the study and provide informed consent exclusion criteria: 1. significant chronic, systemic illness or significant neurologic disorder, including traumatic brain injury 2. clinically significant history of liver disease 3. psychiatrically unstable patients in the clinical judgment of the investigator as indicated by current acute suicidality, current homicidal thoughts, or current psychosis 4. lifetime history of schizophrenia, schizoaffective disorder, or any psychotic illness 5. history of substance abuse or dependence over the past 6 months 6. currently taking medication to assist with sleep (e.g., ambien/zolpidem,dalmane/flurazepam, doral/quazepam, halcion/triazolam, lunesta/eszopiclone, prosom/estazolam, restoril/temazepam, rozerem/ramelteon, sonata/zaleplon, melatonin, unisom, benadryl). 7. pregnant

Keywords: insomnia zaleplon
the role of circulating circrnas and micrornas in acute lung injury

Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome

Summary: efforts to identify circulating factors that predict severity of acute lung injury/acute respiratory distress syndrome（ali/ards）patients is unrevealing. the primary purpose of this study is to verify circrnas and micrornas might be potential novel ali/ards biomarkers and could play roles in pathogenesis of ali/ards.

acute lung injury (ali) or acute respiratory distress syndrome (ards) is a devastating cause of morbidity and mortality characterized by alveolar epithelial and endothelial injury. despite recent advances in pathogenetic mechanisms and therapy strategies of ali, efforts to identify circulating factors that predict severity of ali/ards patients have been unrevealing. circular rnas (circrnas) are a novel class of endogenous non-coding rna with a covalently continuous closed-loop structure. compared with traditional linear rnas, circrnas are more stable and resistant to rnase r due to the absence of 5' caps and 3' tails, which show clear advantages in acting as novel molecular biomarkers for many diseases. in addition, many studies have reported that circrnas can bind to micrornas (mirnas), acting as "mirna sponges" which are named competitive endogenous rnas (cernas), and can regulate gene expression at the transcriptional or post-transcriptional level. evidence indicates that circrnas play important roles in cancers and other diseases such as tuberculosis and intervertebral disc degeneration. as no published research has studied the expression and role of circrnas in the pathology and pathogenesis of ali/ards, the investigators aimed to validate the aberrant expression of circrnas in ali/ards and explore the potential pathological mechanism in which circrnas are involved.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ali/ards * informed consent was obtained from either the subjects themselves or from designated surrogates before enrollment in the study. exclusion criteria: * patients who have chronic lung disease before enrollment. * patients who have severe organ dysfunction, autoimmune diseases and tumor. * women who are pregnant or breast-feeding. * patients who, in the opinion of the investigator, have any other medical condition which renders the patient unable to complete the study or which would interfere with optimal participation in the study or produce significant risk to the patient. * patients participating in or planning to enroll in another clinical trial during the time of the study.

Keywords: circrnas micrornas
pre-operative olanzapine as prophylactic antiemetic in oncologic patients

Conditions: Postoperative Nausea; Postoperative Nausea and Vomiting

Summary: olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and vomiting. the project aims to evaluate the efficacy of olanzapine in combination with ondansetron and dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium and large surgery.

double blinded randomized clinical trial. fifty patients will be selected for each group. group a will receive 10mg olanzapine in the preoperative and group b will receive placebo in the preoperative period. both groups will receive intravenous general anesthesia combined with epidural. all patients will receive epidural pca. the primary outcome of this study is the incidence of post-operative nausea and vomiting. the power of analysis was based on the following parameters: type error i (α = 0.05), error ii (β = 0.8), 95% confidence interval and hypothesis test two-tailed. thus, 42 patients are indicated per group to obtain reduction of the incidence of nausea and / or vomiting of the population risk from 60% to 30%. the population will be composed of 100 patients because it is assumed that percentage of loss of 10% per group. the statistical analysis will be performed in program r version 3.5.1. the results obtained will be presented as mean + standard deviation for continuous data or absolute frequency for described data. for quantitative variables, the student's t-test will be used for with normal distribution or mann-whitney for non-distributed data normal. for qualitative variables, the chi-square test will be used or fisher's exact test. significant difference is defined as p, 0.05. data will be collected and managed using redcap data capture tools

Eligibility criteria:
inclusion criteria: * patients submitted to medium and large surgeries in the thoracic or abdominal region (mastectomies, breast plastic, hysterectomies, annexectomies, gynecological pelvic surgeries, colectomies, rettosigmoidectomies) under general anesthesia * patients aged between 18 and 60 years * patients considered to be at high risk for ponv according to the apfel scale (apfel 3 or 4) * patients with a history of chemotherapy-induced nausea and vomiting. exclusion criteria: * pregnancy or lactation * current use of typical anti-psychotic medications or atypical * history of allergy to olanzapine * myocardial infarction or unstable angina in the 6 months prior to the day of surgery planning * history of severe ventricular arrhythmia (eg, vt or vf) * heart failure class ii or greater second nyha * postural hypotension or vasovagal syncope in the 6 months prior to the day of surgery planning * narrow angle glaucoma * parkinson's disease * dementia * inability to swallow medicines * qt interval history greater than 450ms or torsades de pointes * patient does not want to participate in the study * videolaparoscopy surgery * contraindication for neuraxial block

Keywords: nausea and vomiting
high oral loading dose of cholecalciferol in non-alcoholic fatty liver disease

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: non-alcoholic fatty liver disease (nafld) is a metabolic disorder with high prevalence in patients suffering from chronic liver diseases \[1\]. nafld is characterized by the accumulation of \> 5% of fat deposits in hepatocytes (hepatic steatosis) with no known other reasons for steatosis as excessive alcohol intake.the global prevalence of nafld differs depending on the population reaching 13% in africa, 32% in the middle east, and 30 % in the united states


Eligibility criteria:
inclusion criteria: * either male or female adult patients (\>19 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (us) and with type ii diabetes diagnosed according to american diabetes association (ada) 2019 criteria and treated with metformin exclusion criteria: * pregnant and/or lactating women, excessive alcohol use (defined as an average alcohol intake of\> 30 g per day in men and \> 20 g per day in women), * other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, patients suffering from chronic kidney disease, and hyper/hypoparathyroidism. * hypersensitivity to cholecalciferol, hypercalcemia, patients taking supplementation with vitamin d, and calcium. * medications affecting calcium/vitamin d metabolism (as anticonvulsants, glucocorticoids, and antacids).
dose escalation trial of traditional chinese medicine for irritable bowel syndrome (tcm- ibs)

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to determine whether a 20- herb formulation, as a well characterised extract, is efficacious in treating irritable bowel syndrome (ibs) and also to identify efficacious and safe dosage of the formulation in treating ibs.

the specific aims of the project are: 1. to determine whether a 20- herb formulation improves pain/ discomfort and disturbed bowel frequency in patients with irritable bowel syndrome who have been disappointed with current conventional western medicine. 2. to identify an optimal dosage of the 20- herb formulation that is safe and well tolerated for up to 8 weeks of treatment, among 2 dosages. this is determined by relief of symptoms of ibs in a dose escalation, placebo-controlled double- blind randomized clinical trial, in conjunction with indices of safety and tolerability.

Eligibility criteria:
inclusion criteria: * age 18- 75 * all ibs patients attending the gastroenterology clinic of the prince of wales hospital of hong kong. * ibs diagnosed by rome iii criteria: * recurrent abdominal pain or discomfort at least three days per month in the previous three months * symptoms onset at least six months prior to diagnose * pain or discomfort associated with two or more of the following: 1. improvement with defecation 2. onset associated with change in frequency of stool 3. onset associated with a change in form (appearance) of stool * normal colonic evaluation (colonoscopy or barium enema) in past 5 years * no "global symptom improvement" as rated by patients (see below) at screening and during the two- week run- in period to baseline * normal full blood count, liver function test and renal function test. * informed written consent for participation into study. * ethical approval will be obtained from the joint cuhk-ntec clinical research ethics committee as well as the irb of umb. exclusion criteria: * past or present history of organic disease of gastrointestinal tract (e.g. colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, peptic ulcer and previous gastrointestinal surgery). (note: those with polyps removed during colonoscopy can be included, as long as no known polyps remained. * systemic diseases that cause diarrhea or constipation (e.g. thyroid disease, diabetic neuropathy) * lactose intolerance * severe liver disease (e.g. cirrhosis, chronic active hepatitis) * renal impairment (serum creatinine level \> 150mmol/l) * women who are pregnant, lactating or not practicing proper contraception * known hypersensitivity to herbal medicine * concommitant use of prescription antidepressant medication * current alcoholism and drug use * current psychiatric illness or dementia * fever or severe illness at baseline (week 0).

Keywords: ibs
symptom recognition improves self-care in patients with heart failure.

Conditions: Heart Failure; Symptoms and Signs

Summary: describe a behaviour intervention to analyse self-care engagement in heart failure patients. allocate patients with heart failure into 2 arms study: a control group and an intervention group.

according to medical record at admission, a pilot study was described and included 63 patients in new york heart association (nyha) functional class ii-iii. patients were recruited in a hospital setting after discharge from a heart failure unit. patients were allocated into a control group (n=33) and an intervention group (n=30) through the computerised random allocation generator at http://random.org. the pilot study was performed during three months per patient, with four moments of assessment (baseline, first-week follow-up, first-month follow-up, third-month follow-up).

Eligibility criteria:
inclusion criteria: * adults aged \>18 years old, with diagnosed hf and with no cognitive disability associated. exclusion criteria: * patients placed on the heart transplant waiting list and patients in class iv nyha.

Keywords: heart failure self-care behaviors symptom recognition nurse-led program
diabetes therapy to improve bmi and lung function in cf

Conditions: Cystic Fibrosis; Diabetes Mellitus

Summary: to recruit 150 adult patients with cystic fibrosis related diabetes (cfrd) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (bmi) and stabilize pulmonary function in cystic fibrosis (cf).

the primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve bmi and pulmonary function in cystic fibrosis patients who have diabetes without fasting hyperglycemia.

Eligibility criteria:
* diabetic glucose pattern by oral glucose tolerance test (ogtt) of \>200 at 120 min. (stable and healthy at time of ogtt) * fasting glucose levels \<126. * weight stable within 5% in previous 3 months. * free from illness for two months. * male and female 16 and older, who are done growing * willing to come in for visits every 3 months. * patients receiving infrequent short bursts of systemic glucocorticoids may be considered for the study inclusion if: a. they have not received systemic glucocorticoids steroids for at least one month, b. they did not receive the steroids for more than 14 consecutive days or 28 days total in six months

Keywords: cystic fibrosis related diabetes diabetes without fasting hyperglycemia
elderly independent patients with non small cell lung cancer (nsclc)

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to determine duration before progression of first-line treatment chemotherapy following erlotinib in second-line comparing erlotinib in first-line following chemotherapy in second-line in old patients with none small cell lung cancer.

a multicenter phase ii trial , prospective, randomized, open, non comparative

Eligibility criteria:
inclusion criteria: * age \> 65 years * comorbidities score, * ps frailty score\*\*.according to(table n°1) * no dementia, repeated falls, faecal or urinary incontinence, adl=0, iadl=0 * life expectancy at least 12 weeks * créatinine clearance de la créatinine \> or =30cc/mn according to cockrofts * gault formula * competency to give written informed consent * haematological function as follows: absolute neutrophil count \> 1.5 x 109/l and/or platelet\> 100 x 109/l, hémoglobine \> or = 9,5 g/dl * hepatic function as followed :bilirubin \<1,25 lns sgot/sgpt \<5 x n,pal \<5n * ps \< 3 * no symptomatic cerebral metastasis * histologically or cytologically confirmed nsclc * stage iv/iiib4 (t4with pleural effusion) * no prior chemotherapy for nsclc * relapses of previous nsclc treated by surgery or radiotherapy are eligible if the target is measurable out of initial radiotherapy field and if histological or cytological proof * at least one measurable target lesion by recist guidelines. exclusion criteria: * symptomatic cerebral metastasis * any severe co-morbidity calculated by charlson score (according to table 1), any kind of disorder that compromises the ability of the subject to give written informed and/or comply with the study procedure adl \> or = 1 et iadl \> or =1 dementia, repeated falls, faecal or urinary incontinence- peripheral neuropathy grade 2 or more * performance status \> 2 ( ecog)- contraindication to corticosteroids * unwilling or unable to comply with study requirements for personal , family, sociologic, geographic or any reasons * lack of liberty following administrative or judicial decision * hypersensitivity to polysorbate * hypersensitivity to erlotinib or any excipients of this product * unusual hereditary disorders as galactosemia, deficit in lactase and malabsorption in glucose or galactose * participation in concomitant clinical trial * contraindication to a product of this study disease * bronchioloalvéolar or neuroendocrine or composite carcinoma * superior vena cava syndrome

Keywords: cancer lung cancer none small-cell lung cancer