Kornimate/medical-research-clean huggingface dataset:
locally advanced colorectal cancer and local recurrences in västra götaland

Conditions: Colorectal Neoplasms

Summary: the aim of this study is to review the treatment strategies of locally advanced colorectal cancer and locally recurrent rectal cancer in västra götaland during 1995-2016. the aim is to evaluate time trends and outcome both related to morbidity and cancer specific survival, we will also evaluate the results after advanced reconstruction. the study will identify the population using the swedish colorectal cancer registry and then the individual patient charts will be reviewed. the data will be collected in a clinical record form covering demography (age, sex, co-morbidity, bmi and diagnoses) as well as treatments strategy, surgical procedures, re-operations, complications, readmissions, hospital stay, stoma formation etc.


Eligibility criteria:
inclusion criteria: * locally advanced rectal cancer * local recurrence for colorectal cancer * curative treatment for colorectal cancer exclusion criteria: -
prevention of cancer-associated malnutrition through oral nutritional supplements

Conditions: Cancer

Summary: the aim of the randomized controlled study is to determine effects of an adjusted amount of oral nutritional supplements on the quality of life, the nutritional status, side effects, and response to therapy, in patients with pancreatic and hepatocellular carcinoma receiving palliative therapy.

cancer is often associated with malnutrition and weight loss. the occurence of malnutrition during the course of the disease depends on the type, extent, and therapy of the tumor. pancreatic cancer patients and patients with hepatocellular carcinoma are particularly at risk of developing a pronounced weight loss. cancer-related malnutrition has negative impact on the response to therapy, survival, quality of life, and the infection rate of patients, resulting in prolonged hospital stays and higher costs for health care. maintaining or optimizing the quality of life in patients receiving palliative therapy has priority. since a poor nutritional status affects the quality of life, patients might benefit from the use of an adjusted amount of oral nutritional supplements. to determine the effects of oral nutritional supplements, a controlled randomized study will be conducted.

Eligibility criteria:
inclusion criteria: * assured diagnosis of pancreatic cancer/hepatocellular carcinoma, not treatable with curative intent * palliative systemic therapy of pancreatic cancer respectively palliative therapy of hepatocellular carcinoma with sorafenib or tace (transarterial chemoembolization) * written informed consent prior to inclusion exclusion criteria: * prefinal phase with an estimated life expectancy of less than three months * nutritional support through tube feeding or a central venous catheter * serious malassimilation (assessed by anamnesis) * eastern cooperative oncology group (ecog) performance status ≥ 2 * hepatic encephalopathy ≥ degree 2

Keywords: pancreatic carcinoma hepatocellular carcinoma palliative therapy oral nutritional supplements quality of life nutritional status
heart failure ventricular pressure time profile

Conditions: Heart Failure

Summary: this proposed study aim to: 1. determine intra-lv pressure-time profile non-invasively using recently developed echo doppler vfm analysis and applanation tonometry and myocardial elastic properties, in hf subjects (both hfnef and hfref) compared to normal volunteers. 2. correlate calculated intra-lv pressure parameters with nt probnp levels.

heart failure (hf) is a common disease and its syndrome is difficult to diagnose. hf with reduced ejection fraction (hfref) may be diagnosed based on impaired lvef (\<50%). however, diagnosis of hf with normal ejection fraction (hfnef) is mainly based on the presence of signs and symptoms. central to diagnosis of hf is estimation of intra-cardiac pressure, which can only be obtained from invasive catheterization. this proposed study aim to: 1. determine intra-lv pressure-time profile non-invasively using recently developed echo doppler vfm analysis and applanation tonometry and myocardial elastic properties, in hf subjects (both hfnef and hfref) compared to normal volunteers. 2. correlate calculated intra-lv pressure parameters with nt probnp levels.

Eligibility criteria:
inclusion criteria: * either 1. has presented to hospital with a primary diagnosis of heart failure or 2. is attending a hospital clinic for management of heart failure within 6 months of an episode of decompensated heart failure, which either: * resulted in a hospital admission (primary diagnosis) or * was treated in out-patient clinic * lvef \>50% is used as cut-off value for hfnef and lvef \< 50% for hfref. * nt-probnp within 7 days of admission \> 220pg/ml. if there is no result available, nt-probnp on the same day as echo scan must be \> 220pg/ml. exclusion criteria: * haemodynamically significant valve disease defined as more than mild degree of valve stenosis, or more than moderate degrees of mitral or aortic valve regurgitation. * history of valvular disease, i.e. rheumatic heart disease and/or having undergone valvular replacement. * isolated right heart failure due to pulmonary disease. * presence of haemodynamically significant obstructive lesions of left ventricular outflow tract. * history of any organ transplant or who was on a transplant list (life expectancy \< 6 months at time of enrollment). * presence of end-stage renal failure. * pregnancy. * the patient is unable to provide written informed consent.
a research study to compare semaglutide to insulin aspart, when taken together with metformin and insulin glargine, in people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. insulin glargine is taken once a day and semaglutide once a week. insulin aspart is taken three times per day before a meal. all three medicines come in pre-filled pens for injection under the skin. the study will last for about 71 weeks. if participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. the study doctor will inform the participant about this. the participant will have 15 clinic visits and 22 phone calls with the study doctor.


Eligibility criteria:
inclusion criteria: * male or female, age greater than or equal to 18 years at the time of signing informed consent * diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening * treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening * stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors * glycated haemoglobin (hba1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol) exclusion criteria: * history or presence of pancreatitis (acute or chronic) * any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening * subjects presently classified as being in new york heart association class iv * planned coronary, carotid or peripheral artery revascularisation known on the day of screening * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. however, short term bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in
bone, endocrine and lifestyle longitudinal study

Conditions: Osteoporosis

Summary: the purpose of this proposal is to determine the long-terms effects of hormone and lifestyle factors on bone health in young women over a 20-year time period. it is our primary hypothesis that premenopausal women with irregular periods or endocrine issues related to estrogen will have significantly poorer low back and hip bone health when compared to regularly menstruating women. it is our secondary hypothesis that long-term assessment of changes in endocrine function and lifestyle behaviors will assist in establishing risk factors for osteoporosis in young women. this study will include 1000 premenopausal women. the women will participate in the collection of a blood sample, bone scan, body fat measures, and lifestyle questionnaires. in addition, we hope to use this initial study to develop a group of women to follow throughout menopause, with additional visits occurring every 5 years over the course of their life.


Eligibility criteria:
inclusion criteria: * women at least 18 years of age * free from any uncontrolled chronic disease that may affect bone mass * not pregnant exclusion criteria: * women recently diagnosed with uncontrolled chronic disease(s) at time of enrollment known to affect bone mass, including but not limited to metabolic and endocrine diseases (specifically, diseases of the thyroid and parathyroid glands), osteoporosis, and those women who have taken prophylactic bone density agents, such as fosamax.
risk of recurrent urethral stricture after treatment with paclitaxel-coated dilatation balloon (optilume) compared with non-coated dilatation balloon

Conditions: Urethral Stricture

Summary: urethral strictures are often initially treated endoscopically with dilatation or direct visual internal urethrotomy (dviu), a procedure where the stricture is incised through the vision of a cystoscope. these methods are easy to perform, they are often well tolerated under local anesthesia and they have a low risk of complications. one disadvantage is the relatively low success rate which is 20-60% when used as a first intervention and considerably lower after several interventions. instead of repeated endoscopic procedures, it is advisable to perform open urethroplasty. urethroplasty has a success rate of 65-91% but a higher risk of complications and requires general anesthesia. therefore, there is a need for a treatment option for recurrent urethral strictures after dviu or dilatation, before the urethroplasty is performed. optilume is a ce-marked paclitaxel-coated dilatation balloon used for treatment of urethral strictures. the industry-sponsored randomised robust iii trial from 2022 showed a 75% success rate with optilume but it is not sure if the results can be generalised to patients who would otherwise be candidates for open urethroplasty and whether the drug coating per se increases the efficacy of balloon dilatation. the aim of this study is to investigate whether the addition of paclitaxel-coating can increase the success rate and decrease the need for additional interventions and open urethroplasty for individuals who has a recurrent urethral stricture following at least one previous endoscopic intervention.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * urethral stricture recurrence after at least one internal urethrotomy or dilatation * penile or bulbar stricture * length of stricture ≤ 2 cm * eligible for open urethroplasty * able to give informed consent exclusion criteria: * stricture of the meatus * sclerosis of the bladder neck * multiple strictures \< 16 ch * complete stricture without any lumen * previous dilatation with paclitaxel-coated balloon * previous radiation therapy of the pelvis (e.g. for prostate cancer) * previous pelvic fracture * urethral malignancy * presence of urethral fistula * presence of urethral condyloma * previous open urethroplasty * chronic urinary retention secondary to detrusor inactivity

Keywords: drug-coated dilatation balloon
warm acupuncture for breast cancer related lymphedema

Conditions: Breast Cancer Lymphedema

Summary: the purpose of this study is to clarify whether local-distal point association is more effective than local point association by warm acupuncture in the management of breast cancer related lymphedema.


Eligibility criteria:
inclusion criteria: * at least 6 months after breast cancer surgery and presents with persistent breast cancer related upper extremity lymphedema for at least 3 months. upper extremity lymphedema is defined as more than 2cm circumference difference or 5% volume difference between the affected and unaffected arms. * stage ii or iii lymphedema according to the 2016 consensus by the international society of lymphology. * karnofsky performance score (kps) ≥ 70 * men or women aged 18 to 80 years * out-patients * estimated life expectancy \> 6 months exclusion criteria: * bilateral breast cancer related lymphedema * taking diuretic * history of primary lymphedema * a diagnosis of severe heart, liver, kidney or hematologic disease * edema caused by upper extremity disability or other conditions such as heart failure, kidney disease or malnutrition * have hypoproteinemia * inflammation, scar, or trauma at the site of operation, or other active skin infections * unable to self-care, had a history of psychological disorders, or unable to communicate * received lymphedema treatment within the past 1 month * pregnancy or breastfeeding * the presence of electronic medical device implants * deny to sign the informed written consent, or unwilling to conform to randomization * participation in other clinical trials during the study period
prevalence and outcome of acute hypoxemic respiratory failure

Conditions: Acute Respiratory Insufficiency

Summary: this study is an extension of the spanish initiative for epidemiology, stratification and therapies of acute respiratory failure (siesta) network. the present study is aimed to establish the epidemiological characteristics and clinical outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure \[defined as a pao2/fio2 ≤300 mmhg on positive end-expiratory pressure (peep) of 5 cmh2o or more, and fio2 of 0.3 or more\] admitted in a network of spanish hospitals.

the present study is aimed to establish the epidemiological characteristics and clinical outcomes of adult mechanically ventilated patients with acute hypoxemic respiratory failure \[defined as a pao2/fio2 ≤300 mmhg on positive end-expiratory pressure (peep) of 5 cmh2o or more and fio2 of 0.3 or more\] admitted in a network of spanish hospitals. although there are few previous published observational studies examining the incidence and mortality of patients with acute respiratory failure and ards, there are no studies specifically assessing the epidemiological characteristics, patterns of ventilation and clinical outcomes in patients with acute hypoxemic respiratory failure in the current era of lung protective ventilation. since the study is prospective, with consecutive collection of clinically relevant data from patients and with the participation of several icus from different geographical regions of spain, the findings would be highly generalizable. the study is aimed to improve the knowledge on the epidemiology and outcome of ventilated patients, to identify the percentage of patients developing ards under the current definition, to validate a bedside scoring system developed by us for stratification of lung severity, and to examine the prognosis of hypoxemic respiratory failure, and risk factors associated with fatal outcome.

Eligibility criteria:
inclusion criteria: * age ≥18-year old. * endotracheal intubation and mechanical ventilation, independent of whether the need for ventilatory support is shorter or longer than 24 hours. only patients receiving invasive mechanical ventilation can be included, although patients could have been on non-invasive ventilation before intubation. * pao2/fio2 ≤300 mmhg on invasive mechanical ventilation with a peep of 5 cmh2o or more, and with a fio2 of 0.3 or more. exclusion criteria: * no patients should be excluded (if they meet all the inclusion criteria), regardless of the underlying disease, estimated life expectancy, or duration of invasive mechanical ventilation.

Keywords: respiratory failure mechanical ventilation
skin protectant properties of omeza collagen matrix on damaged skin

Conditions: Transepidermal Water Loss; Erythema

Summary: single-blind within subject comparison study conducted to investigate the skin protectant properties of omeza collagen matrix on damaged skin

this study was conducted in 22 healthy subjects to determine the skin protectant and anti-inflammatory properties of the test product. for the skin protectant assay the test article was applied to the forearm and covered with gauze for 10 minutes before assessment of irritation and tewl readings. an inflammatory skin response was induced by a sls solution 24 hours prior to application of the test article. the test article was applied for 10 minutes at the site of inflammation. the test site was then graded for irritation and tewl readings.

Eligibility criteria:
inclusion criteria: * subject is a healthy male or female, aged 18 years or older. * subject has signed a written informed consent. exclusion criteria: * pregnancy or lactation. * inadequate precaution or procedure to prevent pregnancy (women of child bearing potential only). * a current skin disease of any type at the test site (e.g. eczema, psoriasis) * heavy alcohol consumption in the opinion of the investigator. * a fever in the last 12 hours, prior to the initial patch application. * significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which in the opinion of the investigator would compromise the safety of the subject. * history of malignant disease. * insulin dependent or non-insulin dependent diabetes. * concurrent medication likely to affect the response to the test articles or confuse the results of the study, i.e. routine high dosage use of antiinflammatory drugs (aspirin, ibuprofen, corticosteroids). * known sensitivity to the treatment solutions or their constituents including patch materials. * sensitisation or questionable sensitisation in a repeat insult patch test. * use of self-tanning lotion on the test area, one week previous to the start of the study.
blood collection biorepository for liver disease research

Conditions: Non-Alcoholic Steatohepatitis(NASH); Hepatitis C; Hepatitis B; Fibrosis; Cirrhosis; Fatty Liver; Obesity, Childhood; Bariatric Surgery Candidate

Summary: the purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.

the biorepository at the university at buffalo has been established to collect biological samples from patients with various types of liver disease. the objectives of this biorepository are to stimulate collaboration between clinicians and researchers, to bolster training of junior investigators and to promote multidisciplinary integration to advance translational medicine and to improve the health of patients all over the country. the purpose of this biorepository is to support investigators and to provide them with high quality specimens to promote their efforts in new discoveries or perfecting treatment of patients with liver diseases caused by non-alcoholic fatty liver disease (nafld), non-alcoholic steatohepatitis (nash), hepatitis c virus (hcv), hepatitis b virus (hbv), and human immunodeficiency virus (hiv). the goal is to obtain samples that represent patients seen in the clinics of medical centers in western ny and from some of the rarer diseases encountered in these clinics. the ultimate goal is to develop the biorepository as western new york's resource for clinically annotated human samples that can be used to conduct research that could lead to significant advances in patient care.

Eligibility criteria:
inclusion criteria: * this protocol is to establish a biobank of blood samples from individuals with or without liver diseases including viral hepatitis, liver cancer, nash, and negative control samples. * children and teenagers will be special populations considered in this protocol. exclusion criteria: * vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study.

Keywords: liver disease obesity hepatitis hiv hepatology
a study of idn-6556 in subjects with nafld and raised transaminases

Conditions: Nonalcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease

Summary: the purpose of this study is to determine the safety and efficacy of idn-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests

this is a double-blind, randomized study to evaluate the effects of idn-6556 on serum transaminases and pharmacodynamics of idn-6556 in subjects with non-alcoholic fatty liver disease with elevated alanine aminotransferase.

Eligibility criteria:
inclusion criteria: * male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study * diagnosis of non-alcoholic fatty liver disease (nafld) as evidenced by imaging or other diagnostic assessments * alanine aminotransferase (alt) levels ≥1.5 x uln on at least two occasions, seven or more days apart, during the screening period * alpha-fetoprotein (afp) ≤ 100 ng/ml * hemoglobin ≥10 g/dl, a platelet count ≥ 100 x 10\^9/l, and a white blood cell count ≥ 3.0 x 10\^9/l * if on metformin, sulfonylureas, statins, or fibrates, subjects must be on a stable dose of these drugs for at least three months prior to screening and during the study exclusion criteria: * known infection with hiv, hcv, or hbv * decompensated or severe liver disease as evidenced by one or more of the following: 1. confirmed cirrhosis or suspicion of cirrhosis 2. esophageal varices 3. ascites 4. suspicion of portal hypertension 5. hospitalization for liver disease within 60 days of screening 6. bilirubin \>2 x uln, or alt or ast \> 10 x uln * inflammatory bowel disease * diagnosed or suspected systemic lupus erythematosus (sle) and/or rheumatoid arthritis (ra) * hepatocellular carcinoma (hcc) at entry into the study * history of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas) * significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, and/or serious psychiatric disease, that, in the opinion of the investigator would preclude the subject from participating in and completing the study * history or presence of alcohol abuse, defined as consumption of more than 210 ml of alcohol per week (the equivalent of 14 4-ounce glasses of wine or 14 12-ounce cans/bottles of beer or wine coolers), or other substance abuse within the prior two years

Keywords: nafld nash