Kornimate/medical-research-clean huggingface dataset:
thermal therapy for the treatment of depression in cancer survivors, the s-warm study

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this early phase i trial evaluates the effect of thermal therapy on depression with or without sleep disturbance in cancer survivors. thermal therapy may help improve quality of life, physical capacity, fatigue, and enhance positive mood and sleep quality. the purpose of this study is to evaluate the potential of thermal therapy to improve patient's quality of life by reducing symptoms of depression, sleep disruption, fatigue and anxiety in cancer survivors.

primary objective: i. to evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of depression in cancer survivors. secondary objective: i. to evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of sleep disruption in cancer survivors. exploratory objective: i. to evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of fatigue, anxiety and other generally debilitating aspects of increased stress in cancer survivors. outline: patients undergo thermal therapy over 2.5 hours. after completion of study treatment, patients are followed up at weeks 1 or 2, 3 or 4, and then monthly for months 2-4.

Eligibility criteria:
inclusion criteria: * patients who have had therapy for malignancy * age \>= 18 years * have an eastern cooperative oncology group (ecog) performance status of =\< 2 * patient or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure * patient denies current pregnancy * patients who screen positive on the depression/anxiety domain will be given the hamilton depression rating scale. those with a score of 16 or more on this scale will be eligible for intervention exclusion criteria: * history of prior myocardial infarction. these patients may be allowed with clearance from a cardiologist * history of any condition deemed by the principal investigator to be a contraindication to s-warm therapy (e.g., skin reaction, dysregulation of thermoregulation, etc.) * all patients with transdermal patches (e.g.; fentanyl, lidoderm, scopolamine, etc.) * unwilling or unable to follow protocol requirements * any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive s-warm * received an investigational agent within 30 days prior to enrollment * uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * patients on dialysis
tissue banking study - polycythemia vera or essential thrombocythemia (pv & et) patients

Conditions: Polycythemia Vera; Essential Thrombocythemia

Summary: the purpose of the study is to isolate and characterize stem cells of patients with polycythemia vera (pv) and essential thrombocythemia (et) to find out why these cells are not working the way they should be and why they seem to be sensitive to regulatory factors in the blood, such as clotting.

specific aim 1: assess the effects of rg7112 on mpn hsc/hpc p53 levels and study how it affects mpn stem cell function. specific aim 2. assess the effects of a combination of low doses of ifnα and rg7112 on mpn hsc/hpc.

Eligibility criteria:
inclusion criteria: * polycythemia vera or essential thrombocythemia * agree to give blood for study exclusion criteria: * none

Keywords: tissue banking
escitalopram to placebo in patients with localized pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma; Periampullary Cancer

Summary: use of antidepressants for participants with localized pancreatic and periampullary cancer receiving neoadjuvant therapy.

anti-depressants have been shown to be beneficial in cancer participants. they reduce depressive symptoms and improve quality of life. randomized trials have shown that antidepressants can reduce the development of depression in non-depressed participants with breast, melanoma, and head and neck cancers. it has been shown that treating depression can impact survival in cancer participants. additionally, depressed pancreatic cancer participants have worse survival. therefore, anti-depressants may also have implications for cancer treatment.

Eligibility criteria:
inclusion criteria: 1. subjects must have histologically or cytologically confirmed localized or locally advanced pancreatic ductal adenocarcinoma or other periampullary adenocarcinoma (bile duct, duodenal, ampullary) 2. subjects must not currently be on an antidepressant, anti-anxiety, anti-bipolar, or anti-psychotic medicine 3. aged 18-80 years. 4. ecog ps (eastern cooperative oncology group performance status) score of 0-2 5. planned to have at least 12 weeks of neoadjuvant chemotherapy as standard of care cancer treatment 6. no diagnosis of bipolar disease 7. willing to comply with all study procedures and be available for the duration of the study 8. subjects must be mentally competent and must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. patients under the age of 18 or over 80 2. metastatic pancreatic or other periampullary cancer 3. resection of pancreatic cancer within the past year prior to study enrollment or planned surgery within the next 12 weeks. 4. currently on an antidepressant, anti-anxiety, anti-bipolar or anti-psychotic medicine. patients who have taken maois (monoamine oxidase inhibitors) within the past 6 months are excluded. 5. patients with a history of seizure disorder 6. patients with a recent medical history of myocardial infarction or unstable heart disease 7. patients with a history of qtc prolongation or torsade de points, a baseline qtc 1. interval of \> 500ms, a history of drug-induced qtc prolongation or congenital long qt 2. syndrome 8. patients with child-pugh score of b or c 9. patients with moderate to severe renal disease with a gfr (glomerular filtration rate) \< 45. 10. patients who cannot ingest oral medication 11. patients with any history of mania 12. known allergy to escitalopram 13. pregnancy or lactation
metabolic effect of an innovative chitosan formulation

Conditions: Hypercholesterolemia; Overweight and Obesity

Summary: chitosan is a natural polysaccharide of β-1,4-linked glucosamine residues deriving from chitin, a dietary fiber primarily obtained from fungal cell walls and the exoskeletons of various crustaceans (e.g. crab, lobster, and shrimp) and whose cholesterol-lowering properties are due to the hydrophobic bonds it forms with cholesterol and other sterols, interfering with the emulsification process in the intestine. in addition to reducing low-density lipoprotein cholesterol (ldl-c) levels, several studies showed that chitosan administration may help reduce body weight. for this reason, its use might be particularly useful as a strategy to simultaneously control two different risk factors for the development of cvds.


Eligibility criteria:
inclusion criteria: * subjects agree to participate in the study and having dated and signed the informed consent form; * subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements; * male or female aged ≥ 18 years and ≤ 70 years old; * subjects free from cardiovascular diseases (cvds) (primary prevention for cvds); * subjects with sub-optimal serum levels of cholesterol (total cholesterol (tc) of 200-240 mg/dl or ldl-c of 130-190 mg/dl); * subjects with body mass index (bmi) 25 -34.9 kg/m2 exclusion criteria: * subjects already affected by cvds (secondary prevention for cvds); * subjects with serum levels of triglycerides (tg)\> 400 mg/dl; * type 1 or type 2 diabetes; * lipid-lowering treatment not stabilized since at least 2 months; * known current gastrointestinal diseases and use of medications for their treatment; * known clinically relevant decline in renal function; * women in fertile age not using consolidated contraceptive methods * pregnancy and breastfeeding; * history or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study; * any medical or surgical condition that would limit the patient adhesion to the study protocol

Keywords: hypercholesterolemia overweight class i obesity low-density lipoprotein cholesterol lipids chitosan medical device
vaginal infection study

Conditions: Vulvovaginitis; Vaginitis

Summary: this study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products in the treatment of vaginal infections.


Eligibility criteria:
inclusion criteria: * patients must have a clinical diagnosis of vaginal infection. * patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control. exclusion criteria: * patients must not have any other infections * may not be pregnant or nursing * may not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.
a feasibility study of the bone@bc app version 3.0

Conditions: Breast Cancer Female

Summary: introduction due to improvements in diagnostics and treatments, the 5-year survival for patients with breast cancer is 80-90% after initial diagnosis. during treatments, patients typically have consultations weekly and then gradually reduce to annual visits. during this transition from hospital-based care to health self-management, the breast cancer survivors are encouraged to e.g. exercise because of accumulating evidence for the efficacy of exercise training in cancer survivorship, and in the majority of cases, adhere to endocrine treatments to reduce the risk of breast cancer recurrence. design and methods the study is a one-arm convergent parallel mixed-methods feasibility intervention study. the quantitative data will be the use of the bone@bc app (intervention) and questionnaires (n=50) and the qualitative data will be semi-structured interviews (n= 15 - 20)

aim the aim is to investigate the feasibility and user satisfaction of an app bone@bc version 3.0 and if the app bone@bc can enhance self-efficacy and investigate user statistics and traffic in the app bone@bc by using a convergent parallel mixed-methods design. recruitment and procedure for the quantitative data, the recruitment will follow a consecutive sampling strategy, the follow-up group with the electronic patient-reported outcome (epro) and systematic consultations (n= 50) will be recruited from the endocrinology out-clinic at rigshospitalet, denmark. for the qualitative data, the participants will be recruited from the group participating in the quantitative data following a nested sampling. the patients will be recruited by the principal investigator trine lund-jacobsen (tlj), or clinical physicians from the department of endocrinology, rigshospitalet, denmark. the identification of patients will be given to the principal investigator (tlj) in case the patients are accepted to be contacted for further written and oral information about the project, letter for the subject's rights is handed out and then be provided for obtaining written consent from the patient. the patients who regret or refuse to give consent to participate in the study will be registered and we will note the reason why the patients refuse or regret participating in the study.

Eligibility criteria:
inclusion criteria: * postmenopausal women * age 50-70 years * danish speaking * diagnosed with ebc, stage i-iii * eligible to receive (neo-) adjuvant chemotherapy or adjuvant treatments * access to an e-mail address * access to smart mobile electronic devices connected to the internet * willingness to have the app installed on the smart mobile electronic devices * ability to work with the app exclusion criteria: * prior malignancy * pre-existing type 2 diabetes or other metabolic diseases * withdrawn or not given a consent form
a 26-week trial comparing efficacy and safety of insulin degludec/insulin aspart bid and insulin degludec od plus insulin aspart in subjects with type 2 diabetes mellitus treated with basal insulin in need of treatment intensification with mealtime insulin

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, europe and the united states of america (usa). the aim of the trial is to compare the difference in change in glycosylated haemoglobin (hba1c) between insulin degludec/insulin aspart (idegasp) and/or oral anti-diabetic drugs (oads) and insulin degludec (ideg) plus insulin aspart (iasp)and/or oads.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1) * treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (su)/glinide, dpp-4 inhibitors, alfa-glucosidase-inhibitors * hba1c 7.0% - 10.0% * body mass index (bmi) less than or equal to 40.0 kg/m\^2 exclusion criteria: * treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria * stroke; heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * chronic disorder or disease which might jeopardise safety or compliance * malignant neoplasms * recurrent severe hypoglycaemia
safety evaluation of porous silica in men

Conditions: Safety Issues

Summary: the aim of the present study was to determine whether oral dosing, up to 9 grams/day, of porous silica administered as a food additive can be used safely in normal weight and obese male humans, without significant side effects on gastrointestinal function, bowel emptying habits, and biomarkers.

this single blinded safety study will consist of two study arms and include 10 males each (18-35 years). one arm will include participants with normal weight and one with obesity. after a placebo run-in period, all subjects will be given porous silica three times daily, with increasing dose up to 9 grams/day (phase 1). subjects with obesity continued the study with highest dose for additional 10 weeks (phase 2). the participants will have weekly contacts during with the representative for the study (pi or other research staff). clinical examinations, and blood sampling will be performed day 1, 7, 14, and 21. faeces and morning urinary sampling day 1, and 21. information regarding eating habits, sleep patterns, living conditions and gastrointestinal health were obtained from written forms and orally. if gastrointestinal adverse events would occur after increased dosage, the study staff will adapt the dosage protocol to facilitate adherence.

Eligibility criteria:
inclusion criteria: group - normal weight subjects * age 18-35 * bmi 20-25 group - subject with obesity * age 18-35 * bmi 30-45 exclusion criteria: * chronic somatic diseases that may affect metabolic and/or intestinal function (e.g. diabetes, hypertension, dyslipidemia, irritable bowel disease, gluten intolerance, pancreatic dysfunction, other causes of malabsorption, neoplastic disease,) * allergies with previous anaphylactic reactions * previous abdominal surgery * current or history of eating disorders * extreme or unusual diets such as low carb high fat and vegetarian diets for the last year * psychiatric disorders (e.g. schizophrenia, and other diagnoses that may influence compliance) * drug or alcohol abuse * continuous oral pharmacological treatment and other types of pharmacological treatment that may influence the study * other conditions which the investigator considers could negatively affect the outcome of the study or study compliance
dietary factors and racial disparities in prostate cancer aggressiveness

Conditions: Prostatic Neoplasm

Summary: the north carolina-louisiana prostate cancer project is a population-based case-only study of over 2,000 men newly diagnosed with prostate cancer designed to address racial differences in prostate cancer aggressiveness and survival through a comprehensive evaluation of social, individual, and tumor level influences on prostate cancer aggressiveness. project 3 specifically aims to examine nutritional modulation of prostate cancer aggressiveness using dietary assessment and biomarker-based data on dietary factors.

a total of 2,258 (1,130 african americans and 1128 european americans) men newly diagnosed with prostate cancer in north carolina and louisiana were enrolled into the study between 2004 and 2009. participants signed informed consent and were interviewed by a trained nurse who collected information on demographics, occupation, family history, health status, health care, prostate cancer diagnosis and screening history, medication use, anthropometrics, lifestyle factors (e.g., physical activity, smoking), and diet and supplement use. research subjects were asked to recall their diet in the year prior to prostate cancer diagnosis via a modified version of the national cancer institute diet history questionnaire. vitamin and supplement use in the year prior to prostate cancer diagnosis was assessed via a validated questionnaire, and current use was assessed by bottle label inventory. blood, urine, and adipose tissue samples were collected.

Eligibility criteria:
inclusion criteria: * first diagnosis of histologically confirmed adenocarcinoma of the prostate * 40-79 years old at diagnosis, * can complete the study interview in english, * do not live in an institution (nursing home), * are not cognitively impaired or in a severely debilitated physical state, * are not under the influence of alcohol, severely medicated, or apparently psychotic at the time of the interview. * must self-identify as at least part african american/black or caucasian american/white/european american. exclusion criteria: -
how much reliable iv calcium for the treatment of hyperkalemia?

Conditions: Acute Renal Failure; Chronic Renal Failure

Summary: hyperkalemia is a common problem in the emergency services and one of the life threatening metabolic emergencies. calcium, insulin, beta adrenoceptor agonists, bicarbonate, diuretics, sodium polystyrene sulfonate and lastly dialysis are advised in treatment. especially, avoiding evolution of serious arrythmias and iv calcium using in the treatment of occured electrocardiogram (ecg) abnormalities, there is not sufficient level of survey in the literature. so the aim of this study was to evaluate administration of iv calcium efficiency on vital signs and ecg.

hyperkalemia is a common problem in the emergency services and one of the life threatening metabolic emergencies. serious hyperkalemia is mostly seen in patients who have known chronic renal failure or end stage renal disease, and also new diagnosis of acute renal failure can be appear with serious hyperkalemia. paresthesia and weakness which is proceeded to flask paralysis can be observable, sharp ''t'' waves (the repolarization and relaxation of the ventricles), diminution of ''p'' waves (atrial depolarisation and contraction), long ''pr'' intervals (time frame from the beginning of atrial depolarization to the beginning of ventricular depolarization), or elongated ''qrs'' complexes (depolarisation and contraction of the ventricles), ''st'' segment (end of the qrs complex to the beginning of the t wave) elevation, and serious ventricular arrythmias can be seen in electrocardiography. calcium, insulin, beta adrenoceptor agonists, bicarbonate, diuretics, sodium polystyrene sulfonate and lastly dialysis are advised in treatment. especially, avoiding evolution of serious arrythmias and i̇v calcium using in the treatment of occured ''ecg'' abnormalities, there is not sufficient level of survey in the literature. the group of cochrane stated in systematic assessment report, which is published in 2005 about iv calcium administration, available dates are based on anecdotal and animal experiments. and in the researches that we have done, we did not find clinical human studies showing the benefits of calcium administration beyond the delivery of case reports . the aim of this study was to evaluate administration of i̇v calcium efficiency on vital signs and ecg.

Eligibility criteria:
inclusion criteria: * all patients who had ecg changes due to hyperpotassemia (k\>5.5 mmol/l) exclusion criteria: * arrest patients * patients needed antiarrhythmic interventions * patients need inotropic that may cause ecg changes * patients need atropine during emergency treatment prior to ca-gluconate * patients needed cardioversion or defibrillation * hyperpotassemia with myocardial infarction * in the presence of other situations which changes ecg for example pericarditis * unstabile patients for ideal ecg * digoxin usage * trauma * blood calcium level of \> 10.5 mg/dl

Keywords: calcium gluconate hyperpotassemia treatment
clinical performance of nano plus sirolimus-eluting stents in patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: the study aims to evaluate the safety and efficacy of polymer-free sirolimus-eluting coronary stent system (nano plus) in patients with coronary artery disease . the primary endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel related myocardial infarction and clinically-driven target lesion revascularization at 1 year follow-up.

this is a prospective, multicenter, single arm clinical registry investigating the safety and efficacy of polymer-free sirolimus-eluting coronary stent system (nano plus) in patients with coronary artery disease . in total, we plan to recruit 2500 patients in real world setting. the patients will be followed clinically at 1-, 6- month and 1-, 2-, 3-, 4-, 5-year. all clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee.

Eligibility criteria:
inclusion criteria: * 18-85 years old, male or non-pregnancy female; * patients with coronary artery disease who match the indication of stent implantation; * patients who can understand the nature of the study, agree to participate and accept clinical follow-up; exclusion criteria: * patients who can not tolerate the material or medication in this study; * pregnancy or lactation women * patients who had participated in another investigational drug or device trial that has not completed the primary endpoint; * patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol