Kornimate/medical-research-clean huggingface dataset:
radiation therapy for ypn0 breast cancer

Conditions: Breast Cancer

Summary: this is a phase iii randomized study comparing regional nodal irradiation vs. no irradiation for breast cancer patients presenting with node positive disease who turns into node negative after preoperative chemotherapy


Eligibility criteria:
inclusion criteria: * who performance status 0-1 * invasive breast cancer with ct1-3 cn1-2 at time of diagnosis * axillary nodal involvement can be detected using, clinical examination, ultrasound, ct scan or pet scan * pathologic confirmation using, fnac, core biopsy or excisional biopsy * er, pr, her2 neu and ki67 status should be available for all patients * all patients should have received standard preoperative chemotherapy prior to surgery * at the time of surgery, all patients should have axillary clearance with at least 6 nodes harvested from the axilla * patients who have undergone mastectomy or lumpectomy with negative margins with ypn0, ypn0(+i) or ypn0(+mol) are eligible for randomization exclusion criteria: * poor performance status * definitive clinical or radiologic evidence of metastatic disease * t4 tumors including inflammatory breast cancer * n3 disease detected clinically or by imaging * patients with histologically positive axillary nodes after preoperative chemotherapy * positive surgical margin after definitive surgery * previous ipsilateral or contralateral breast cancer * previous chest wall or breast irradiation * second primary cancer * active connective tissue disease

Keywords: breast cancer regional nodal irradiation preoperative chemotherapy
prospective evaluation of prognosis of pci patients using network data in shengjing hospital

Conditions: Coronary Heart Disease

Summary: coronary heart disease (chd) has a serious health threaten to population. pci is a well-proved measure in chd management. however, the knowledge about the real-life pci use and how evidence-based therapies in routine clinical practice is limited. by consecutively recruiting pci patients in a large-scale hospital in in northeast china,this study will examine various real-life factors, that may affect patients recovery after the procedure. practical guidelines, appropriateness criteria and quality evaluative system for pci will be established based on the findings, to improve patients outcomes in future finally.

cardiovascular disease (cvd) is a major concern in public health in china. relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. practical and applied knowledge from large unselected population is needed to guide practice for quality improvement. this study will enroll patients undergoing pci in a large-scale hospital in in northeast china. at study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. cag imaging will be reviewed by 2 cardiologists through pacs. other procedural data, including stent type, total stent length and so on, came from operation records of pci cases finished by operators. at 1 month, 6 month, 12 month, 3 year and 5 year after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. if participants can not return to the clinic for follow up visits,a telephone interview will be conducted to get the related information. before discharge,, blood sample will be collected. participants' blood samples will be stored for future biologic and genetic studies. this study will examine various real-life factors that may affect patients recovery after pci, including patients' characteristics and treatment measures. practical guidelines, quality evaluative system, and appropriateness criteria will be established based on the findings, to improve patients outcomes in future finally.

Eligibility criteria:
inclusion criteria: * hospitalized patients undergoing a percutaneous coronary intervention (pci) for coronary lesions. exclusion criteria: * previously enrolled in the r-push study

Keywords: percutaneous coronary intervention
integrated positron emission tomography - computed tomography (pet-ct) in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: in suspecting pancreatic cancer, dynamic phase pancreatic ct is the most effective tool in diagnosis and staging. in addition, magnetic resolution image, endoscopic ultrasonography, endoscopic retrograde pancreatography, angiography can be performed. after introduction of functional image, pet has been suggested in the role of diagnosis and staging of pancreatic cancer. furthermore, recently fused images of pet and ct were available. in this study, the researchers evaluate the role of integrated pet-ct in patients with pancreatic cancer and analysis the cost-effectiveness of the integrated pet-ct.

compared to dynamic phase pancreatic ct, integrated pet-ct will be evaluated for sensitivity, specificity and accuracy of diagnosing and staging pancreatic cancer while the gold standard for pancratic cancer is operative specimen. if the operation can't be performed, eus-fna of the pancreatic mass or lymph node and additional imaging modality will be preferred to laparotomy.

Eligibility criteria:
inclusion criteria: * pancreatic mass suspicious of pancreatic cancer * no comorbidity, expected life expectancy less than 6 months * consent this study in letter exclusion criteria: * refuse diagnostic and staging work-up

Keywords: pancreatic cancer integrated pet-ct
impact of increasing levothyroxine dose in ramadan for uae patients with hypothyroidism

Conditions: L-thyroxine

Summary: the study aims to compare the mean change in thyroid stimulating hormone (tsh) levels among patients with hypothyroidism treated with an increased dose of l-thyroxine (treatment group) versus standard/regular dose of l-thyroxine (control group) during the month of ramadan.

the present study is an open-label, two-arm parallel groups, randomized controlled clinical trial that included emirati patients with hypothyroidism who attended the family promotion centre, endocrinology clinic, regularly. eligible participants (n = 103) were randomly allocated to the treatment group (patients who received an increased dose of l-thyroxine, 25 mcg, n = 50) and the control group (patients who received standard/regular dose of l-thyroxine, n = 46). both groups attended 5 visits before, during, and after ramadan. several tests were conducted including thyroid function, lipid profile, hba1c, and vitamin d.

Eligibility criteria:
the inclusion criteria for participants will include: 1. male and female patients with primary hypothyroidism. 2. patients with stable tsh 3. aged between 18 and 70 years. 4. patients regularly fasting for at least 25- 30 days during ramadan. 5. emirati nationals (100% health care coverage) exclusion criteria: 1. patients with any end organ damage 2. pregnant or breast-feeding women 3. thyroid cancer 4. patients not adhering to initial thyroxine medications. 5. those receiving proton pump inhibitory therapy, dietary fiber, bile acid sequestrates, ferrous sulfate, sucralfate, calcium carbonate, aluminum-containing antacids, phosphate binders, and raloxifene. 6. disease interferes with thyroxine absorption, coeliac disease, inflammatory bowel disease, lactose intolerance as well as helicobacter pylori (h. pylori) infection and atrophic gastritis, 7. several other factors cause treatment failures such as fiber-rich food, soy protein, grapefruit, and aluminum antacids, which interfere with thyroxine absorption. in addition to calcium carbonate and ferrous sulfate. 8. patients were diagnosed with cardiovascular disorders, including angina, coronary artery disease, and hypertension.
persistent pain after reconstruction following mastectomy

Conditions: Breast Cancer; Chronic Pain

Summary: a cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.

the aim of the study is to determine if reconstruction of the breast after mastectomy increases the risk of reporting persistent pain 2-3 years after surgery.

Eligibility criteria:
inclusion criteria: * patients with unilateral primary breast cancer aged 18-70 years exclusion criteria: * recurrent cancer * other malignancy * emigration * non-standardized treatment

Keywords: pain neuropathic pain chronic pain
trk-700 drug-drug interaction study with digoxin and midazolam

Conditions: Healthy

Summary: this study comprises 2 cohorts, and in each cohort, the study will be conducted as an open-label add-on study. the purpose of the study is to investigate the pharmacokinetics of each substrate in concomitant administration of a single dose of the p-glycoprotein substrate digoxin (cohort a) or the cyp3a4 substrate midazolam (cohort b) during repeated administration of trk-700 in healthy adult males.


Eligibility criteria:
inclusion criteria: * japanese healthy adult males. * subjects with a bmi of at least 18.0 and less than 30.0 at the screening examination and the examination at admission. exclusion criteria: * subjects with significant concomitant or historical disease of the metabolism, liver, kidneys, blood, lungs, heart, digestive organs, urinary organs, or nerves, or psychiatric diseases, accompanied by clinical symptoms or with other clinically significant disease, who are unsuitable for participation in this study, in the opinion of the investigators. * subjects who are found by the investigators to have significant clinical abnormality at the screening examination, the examination at admission, or the examination at the day of first administration of digoxin or midazolam.

Keywords: trk-700 pk digoxin midazolam drug-drug interaction p-glycoprotein cyp3a4 mdr1 pharmacokinetics multidrug resistance 1
bucillamine study of holding remission after infliximab dose-off

Conditions: Rheumatoid Arthritis

Summary: patients with rheumatoid arthritis who have been well controlled with methotrexate plus infliximab may remain in remission or low disease activity without infliximab. and the chance of sustained remission increase by the addition of another dmard, bucillamine, at the time of discontinuing infliximab. the bushido trial is the prospective, randomized, controlled study comparing mtx monotherapy and mtx plus bucillamine combination therapy as to the rate of disease flare after discontinuing infliximab.


Eligibility criteria:
inclusion criteria: * ra according to american college of radiology (acr) classification criteria * age of 20 or greater * das28-esr \< 3.2 or das28-crp \< 2.6 for more than 6 months exclusion criteria: * previously teated with bucillamine * pregnancy or lactation
guanfacine extended-release for adolescents with cannabis use

Conditions: Cannabis Use Disorder

Summary: a randomized controlled trial to assess the efficacy of extended-release guanfacine to reduce cannabis use frequency in young people with cannabis use disorder following a period of monitored abstinence.


Eligibility criteria:
inclusion criteria: 1. 12-25 years of age (inclusive) at consent; 2. seeking treatment for cannabis use; 3. dsm-5 cannabis use disorder, mild, moderate or severe; 4. self-reported cannabis use on average at least 5 days/week during the 28 days prior to screening with a thc positive urine drug screen on the day of screening; and 5. able to provide informed consent (both adequate iq and english fluency; \<18-year-olds will provide consent themselves in addition to parent/guardian consent). exclusion criteria: 1. dsm-5 substance use disorder (moderate or severe) except cannabis or nicotine; 2. any unstable medical, psychiatric or neurological condition or medical contraindicating study participation; 3. diagnosis of a psychotic or bipolar illness; 4. acute suicidality as assessed by clinician; 5. prescribed antipsychotics, benzodiazepines or other sedative medications, or other medications for the treatment of adhd. if prescribed antidepressants, the participant must have been on a stable dose for more than 2 weeks at screening; 6. a history of heart disease or cardiac risk factors (e.g. arrhythmias); 7. abnormal liver or thyroid function as indicated by clinically-significant findings on blood tests; 8. pregnancy, breast feeding or, if sexually active and able to become pregnant, no effective contraception. 9. intention to enter residential rehabilitation after treatment in the ysas residential withdrawal facility.
comparison between mediterranean diet and high protein diet in women with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) affects 5-10% of women and is the most common endocrine syndrome.pcos is associated with infertility, risk for obesity and type 2 diabetes. the elevated insulin characteristic of pcos is likely to play a major role in its symptoms. restricted calorie high protein diet and mediterranean diet may improve insulin sensitivity and therefore lower androgen production in women with pcos women.the purpose of this study is to determine which diet is more effective in improving metabolic and reproductive outcomes.

polycystic ovary syndrome (pcos) is a heterogeneous syndrome affecting 5-10% of women of reproductive age. it is characterized by elevated circulating insulin, reduced insulin sensitivity, infertility, hyperandrogenism, and a multitude of symptoms that result in a decreased quality of life. the elevated insulin characteristic of pcos is likely to play a major role in its pathogenesis by reducing insulin sensitivity and stimulating excess androgen production hence causing an hormonal imbalance. low calories diets have shown to improve pcos symptoms but the optimal diet for all pcos women is still unknown. in this study, our purpose is to compare two lowering insulin restricted calories diets in order to find the optimal diet for improving metabolic and endocrin outcomes in pcos women we will also investigate which diet has the best long lasting compliance.

Eligibility criteria:
inclusion criteria: * polycystic ovary syndrome exclusion criteria: * pregnancy * lactation 6 month prior to study * known hyperandrogenism * more then 5 kg weight loss 6 month prior to study * imbalance pituitary hormones * alcohol or drug abuse * chronic disease - kidney/heart/diabetes/lung * psychiatric disease * drug use accept contraceptive pills

Keywords: polycystic ovary syndrome (pcos) diet mediterranean diet high protein diet
therapeutic drug monitoring of teicoplanin in children

Conditions: Bacterial Infections

Summary: in this study, the therapeutic drug monitoring of teicoplanin is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. then we analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of teicoplanin in chinese children.


Eligibility criteria:
inclusion criteria: * teicoplanin was administered intravenously; * teicoplanin was used for therapeutic purposes; * age:≤18 years; * clinician confirms and plans to diagnose the patient with gram-positive coccus infection; * patients with therapeutic concentration monitoring of teicoplanin. exclusion criteria: * teicoplanin was administered non-intravenously; * teicoplanin was used for prophylactic purposes; * patients without therapeutic concentration monitoring of teicoplanin; * patients who die within 24 hours of the use of teicoplanin； * the blood concentrations of the patient was not approved by the quality control center.
rituxmab versus il-6 in treating ild

Conditions: Interstitial Lung Disease; Scleroderma

Summary: all ssc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test

all ssc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test diffuse infiltrative lung disease (ild): progressive shortness of breath is the most frequently presentation going to er pulmonary unit first. it should be considered in case of persistent dry cough or dyspnea, which should be looked for in any patient with ssc. an etiological assessment must be conducted in order not to mistakenly attribute ild to the ssc.

Eligibility criteria:
inclusion criteria: * active ild scleroderma exclusion criteria: * abnormal liver enzymes renal impairment neutropenia \<1000 cells/mm3 thrombocytopenia \< 50,000 cells/mm3
prospective study of short course radiation therapy followed by neoadjuvant chemotherapy and surgery in locally advanced rectal cancer

Conditions: Locally Advanced Rectal Carcinoma

Summary: the goal of this clinical trial is to investigate total neoadjuvant therapy (tnt) using short course radiation therapy (scrt) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. the main questions it aims to answer are: * is total neoadjuvant treatment in this design safe \& tolerable? * impact of this design on treatment related outcomes in terms of pathological and clinical responses.

patients will be assigned to an experimental arm in which preoperative short course 5 x 5 gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks

Eligibility criteria:
inclusion criteria: * histopathological proof of rectal adenocarcinoma. * tumors located within 15 cm and not less than 4 cm from anal verge. * age: ≥ 18 years. * locally advanced resectable rectal cancer (ct3/4 n0- any t n+ve). * ecog performance status: 0-2. exclusion criteria: * non-epithelial rectal malignancy such as sarcoma or lymphoma. * unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen. * recurrent rectal cancer. * previous history of malignancy within the last 5 years. * previous pelvic irradiation. * psychiatric or addictive disorder that would preclude study therapy. * concurrent uncontrolled medical conditions. * pregnancy or breast feeding. * any contraindication to surgery. * extensive peripheral neuropathy.

Keywords: advanced rectal cancer- short course radiation - chemotherapy-surgery
efficacy and safety evaluation of the imescard compound water smartweed ointment

Conditions: Hemorrhoidal Disease

Summary: the aim of our study was to assess the clinical efficacy and safety of the drug imescard compound water smartweed, adrenalin and hamamelis ointment in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.

the drug imescard compound water smartweed ointment is currently registered at the brazilian national sanitary surveillance agency (anvisa) as a topic hemorrhoidal treatment. it's composed by adrenalin, which produces vasoconstriction, benzocaine, an anesthetic, hamamelis, which is believed to have a desiccative and astringent activity, and water smartweed (polygonum hydropiperoides), commonly used in the treatment of this condition, with, however, little or no evidence other than tradition to support its use. the aim of this study was to assess the clinical efficacy and safety of this drug in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial. sixty healthy volunteers with ages between 18 to 70 years old who presented with 2nd to 4th degree hemorrhoids were enrolled after clinical and laboratory evaluation (day 0) and then randomized (day 1) to receive either the imescard ointment after waking up, after evacuations and before bedtime, for 5 days, or placebo, with the exact same appearance and posology. at followup (day 8), patients underwent new clinical and laboratory evaluation. main outcome was the percentage of patients with 50% improval of symptoms, assessed by a diary containing symptom questionnaires concerning every day of treatment. secondary outcomes were mean scores of the symptom questionnaires, life quality improval assessed by whoqolbrief at days 1 and 8 and adverse effects evaluation.

Eligibility criteria:
inclusion criteria: * age between 18 and 70 years old * 2nd to 4th degree hemorrhoids clinically diagnosed * proper anticonception, in the case of women in fertile age * possibility to abstain from any other drugs (except in emergencies, in wich case the responsible party must be informed) * good understanding and agreement to informed consent form exclusion criteria: * hypersensitivity to any of the components of the drug * use of alcohol or drugs * clinical evidence of immunosupression * abnormalities in baseline laboratory exams * diagnosis of any acute disease in current activity or chronic disease uncontrolled

Keywords: hemorrhoids hemorrhoidal disease water smartweed hamamelis rct
cord blood alarin levels in term babies

Conditions: Birth Weight

Summary: in this study, alarin levels in the cord blood of babies with large birth weights will be compared with babies of normal weight. thus, the investigators aimed to find out whether there is a relationship between babies' birth weights and alarin.

studies have shown that the galanin neuropeptide family plays a role in regulating appetite, insulin resistance, obesity, hypertension and metabolism. alarin is a peptide consisting of 25 amino acids. current research shows that allerin plays an important role in the emergence and development of diabetes and obesity. there are studies that found that the serum alarin level increased significantly in patients with impaired glucose tolerance and type 2 diabetes mellitus. additionally, studies have found that both non-obese and obese type 2 diabetes mellitus serum alarin levels increase. studies in the literature are related to adults, and there are no studies on alarin levels in newborn babies. based on the alarin studies available in the literature, the investigators determined whether there is a relationship between the alarin level and the baby's birth weight by comparing the alarin level in the cord blood of babies with a high birth weight according to their gestational age (both babies of diabetic mothers and babies of non-diabetic mothers) compared to babies whose birth weight is within the normal range. the investigators aimed to find it.

Eligibility criteria:
inclusion criteria: * babies given consent by their families * healthy babies exclusion criteria: * babies with syndromic appearance or any accompanying disease * babies whose family does not give consent

Keywords: newborn alari̇n umbi̇li̇cal cord blood