Kornimate/medical-research-clean huggingface dataset:
her-2/neu in patients with metastatic breast cancer (adhere)

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an adenovector expressing rat her-2/neu (adher-2/neu) in patients with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. metastatic or locally recurrent breast cancer 2. 18 years of age or older 3. her-2/neu positive (3+ by immunohistochemistry or fluorescence in-situ hybridization \[fish\] +) 4. one of the following: 1. currently receiving hormonal therapy or are candidates for such, or 2. being considered for trastuzumab, or 3. cancer has progressed on trastuzumab. exclusion criteria: 1. pregnant or lactating women. 2. prior or concurrent malignancies except for treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured for more than five years prior to study entry. 3. currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. \[note: concurrent hormonal therapy (tamoxifen, aromatase inhibitors, or megace) is permitted.\] 4. treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy. 5. hemoglobin \< 80 g/l or granulocytes \< 1.5 × 10\^9/l or lymphocytes \< 1.0 × 10\^9/l or platelets \< 100 × 10\^9/l. 6. baseline liver enzymes (ast or alt) greater than 3 times the upper limit of normal or greater than 5 times the upper limit of normal if liver metastases are present and/or bilirubin is greater than 50 mmol. 7. cd4 cells \< 0.5 ×10\^9/l 8. patients with documented brain metastases. 9. patients with any acute illness that would interfere with the collection of cd34+ cells or administration of vaccination cellular therapy (i.e. unstable angina, renal or liver failure, or severe chronic obstructive airway disease). 10. any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids). 11. eastern cooperative oncology group (ecog) performance status of \> 2. 12. patients with a life expectancy of less than 6 months. 13. geographic inaccessibility which would preclude follow-up. patients registered on the trial must be treated and followed at the juravinski cancer center and the henderson site of the hamilton health sciences. 14. failure to give written informed consent. 15. baseline left ventricular ejection fraction (lvef) \< 55% by echocardiography or multigated acquisition (muga) scan.

Keywords: metastatic breast cancer locally recurrent breast cancer
high dose vitamin a compound in treating participants with resectable non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer; Stage I Lung Cancer; Stage Ib Lung Carcinoma; Stage IA Lung Carcinoma AJCC V7; Stage IIA Lung Carcinoma; Stage IIIA Lung Carcinoma

Summary: this trial studies how well high dose vitamin a compound works in treating participants with non-small cell lung cancer that can be removed by surgery. vitamin a compound may increase the number of germinal centers (immune centers that make antibodies mature) in tumor and lymph tissues which may be beneficial to patients with cancer.

primary objectives: i. to compare the percentage of resected cancers containing germinal centers (gcs) in patients who receive neoadjuvant vitamin a compound (vitamin a) to controls. secondary objectives: i. to compare the abundance of gcs in adjacent lymph nodes in patients who receive neoadjuvant vitamin a to controls. ii. to compare histopathologic responses based on tumor necrosis in lung cancer patients who receive neoadjuvant vitamin a to controls. iii. to compare overall survival of patients who receive neoadjuvant vitamin a to controls. exploratory objectives: i. to describe immunophenotypic changes of monocytes including myeloid derived suppressor cells (mdscs) in pre- and post-treatment blood samples. outline: participants are randomized to 1 of 2 groups. group i: participants receive vitamin a compound orally (po) for 7 consecutive days in the absence of disease progression or unacceptable toxicity. within 21 days of completing treatment, participants then undergo surgical resection. group ii: participants undergo surgical resection. after completion of study treatment, participants are followed up for 30 days.

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older. * patients must have either biopsy proven or radiographically suspected non-small cell lung cancer. * patients must have disease in the chest that is felt to be surgically resectable. * ecog performance status of 0-2. * ability to understand and the willingness to sign an irb-approved informed consent document exclusion criteria: * patients younger than 18 years of age * women who are pregnant or breast feeding. * patients may not be receiving any other investigational agents for the treatment of nonsmall cell lung cancer. * patients may not be taking the following medications: high dose vitamin a supplement (multivitamin supplements prohibited only if vitamin a content is greater than 3,500 international units), bexarotene, alitretinoin, tretinoin, adapalene, isotretinoin, acitretin, doxycycline, minocycline, or demeclocycline, * uncontrolled intercurrent illness including, but not limited to, pancreatitis, 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. * hypervitaminosis a - toxic effects of ingesting too much vitamin a.
a trial of single incision versus four ports laparoscopic cholecystectomy

Conditions: Cholelithiasis

Summary: background: single-incision laparoscopic cholecystectomy (silc) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (lc) in terms of postoperative pain and faster recovery. methods: seventy-three patients with symptomatic cholelithiasis were randomized to silc (n=37) or lc (n=36). data measures included operative details, adverse events, postoperative pain and analgesic requirements, success of the ambulatory process, return to normal activity and return to work, cosmetic results and quality of life score.


Eligibility criteria:
inclusion criteria: * age higher than 18 and lower than 80 * american society of anesthesiologists class (asa) i-ii, * absence of any previous anesthetic complication, * accompaniment by a responsible adult during 24 hours, * symptomatic gallstones candidate to cholecystectomy * and a signed informed consent. exclusion criteria: * a body mass index (bmi) higher than 35, * any laparoscopic contraindication, * acute cholecystitis background, suspect of mirizzi's syndrome, common duct stones or malignancy, * anti-inflammatory allergy * psychiatric history that could hinder ambulatory procedure
evaluation of a diet in patients with senile dementia

Conditions: Alzheimer's Disease; Parkinson's Disease; Senile Dementia

Summary: the most common symptoms associated to senile dementia disease are confusion about schedules, hyperactivity... in this sense, these patients have frequently poor nutrition, resulting in malnutrition problems or malnutrition high risk.

the purpose of this study is to assess if the daily intake of a specific nutritional supplement versus a non specific supplement one is related to malnutrition or malnutrition risk reduction and contributes to an improvement in cognitive and functional parameters in patients with senile dementia.

Eligibility criteria:
inclusion criteria: * patients over 70 years with neurologist or geriatrician dementia diagnosis (alzheimer's disease, parkinson's or mixed), with mild or moderate cognitive impairment degree (between 24 and 14 mmse). * patients with or at malnutrition risk (mini nutritional assessment screening positive) exclusion criteria: * patients with decompensated kidney failure, creatine and/or bilirubin greater than 2, uric acid higher than 8 mg/dl, and glomerular filtration under 60 ml/minute. * patients with diabetes mellitus poorly controlled (glycemia \> 200 mg/dl) * patients with decompensated hypertension. * patients with pharmacological treatment or consuming supplements containing specific supplementation of experimental product (omega 3 and/or vitamins supplements). * post-stroke vascular dementias. * do not achieve any inclusion criteria.

Keywords: senile dementia neurodegenerative supressi specific diet cognitive status memory malnutrition parkinson alzheimer
unripe banana peel powder and lemongrass oil in chronic ulcer

Conditions: Chronic Ulcer; Healing Ulcer

Summary: to evaluate the activity of a gel composed of 10% peel powder of unripe banana (musa sapientum) combined with lemongrass (cymbopogon citratus) oil, at 0.1% concentration, in patients with chronic ulcers.

purpose: to evaluate the activity of a gel composed of 10% peel powder of unripe banana (musa sapientum) combined with lemongrass (cymbopogon citratus) oil, at 0.1% concentration, in patients with chronic ulcers. methods: this is a clinical, individual, analytical, interventional, longitudinal, prospective, controlled study with convenience sampling. three groups will be used, as follows: control group 1 (cg1) with 7 participants will be treated with collagenase, control group 2 (cg2) with 7 participants will be treated with a gel composed of 10% unripe banana peel powder, and study group (sg) with 11 patients will be treated with the abovementioned gel combined with lemongrass oil at 0.1% concentration. the ulcer areas will be analyzed once a week for 4 weeks. afterward, wound areas will be measured and the obtained data will be subjected to statistical analysis.

Eligibility criteria:
inclusion criteria: * presence of chronic ulcers, * 18 years of age and older exclusion criteria: * patients who had any type of allergic reaction to the study products during treatment

Keywords: healing ulcer chronic ulcer musa sapientum lemongrass
preventive therapy with ursodiol to reduce the incidence of gallstones formation in patients after bariatric surgery

Conditions: Morbid Obesity

Summary: risk factor of cholelithiasis is rapid weight loss after bariatric surgery and change in the gallbladder function which is secondary to surgery. many observational studies support this fact, and a high incidence of 28% -71% after gastric bypass surgery (rygb) was reported in them. according to another publication, the incidence of gallbladder diseases is 5-36% after jejunoileal bypass surgery and 2.8-36% after gastric bypass surgery.

study format: prospective, randomized, blinded study. 266 candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with bmi range of 40-50 and aged 18-65 will be studied. the patients will be randomly divided into two groups (according to the last digit of the identity card number): 1. treatment group will receive preventive therapy with ursodiol 600 mg per day as of day 10 after the surgery (at the first routine visit after the surgery) and for six months or until the formation of gallstones. 2. placebo group will receive placebo as of day 10 after the surgery (at the first routine visit after the surgery) and for six months or until the formation of gallstones.

Eligibility criteria:
inclusion criteria: * candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with bmi range of 40 to50. * aged 18 to 65. * no presence of gallstones. * patients who have signed the consent form. exclusion criteria: * minors, * pregnant women, * age over 65, * sensitive to ursodiol, * gallstones, * biliary tract pathologies, * gallbladder wall thickening, * patients after cholecystectomy, * patients participating in another clinical trial.

Keywords: morbid obesity, cholelithiasis bariatric surgery ursodiol
assessment of the impact of two dexmedetomidine dosages added with bupivacaine in ultrasound-guided transversus abdominis plane block for postoperative analgesia following inguinal hernia repair

Conditions: Spinal Anaesthesia; Herniorrhaphy; Transversus Abdominis Plane Block

Summary: the principal outcome assessed was the duration until the initial request for analgesia post-surgery. the secondary outcomes encompassed the total quantity of analgesics administered (ketorolac, paracetamol, and morphine) within the initial 24 hours. pain levels, measured using the visual analogue scale (vas), were evaluated at rest and during movement at many intervals following surgery (1, 6, 12, and 24 hours). the study also observed postoperative complications, such as emesis, hypotension, bradycardia, and pruritus.

one of the most frequently performed surgical procedures worldwide is the repair of an open inguinal hernia, with a postoperative pain severity of moderate to severe affecting over 60% of patients. post-surgical analgesia frequently employs a multifaceted approach, incorporating oral pharmacotherapy and regional anesthetic procedures. opioids are a conventional option for postoperative pain management; nevertheless, their administration is linked to adverse effects such as nausea, vomiting, sleepiness, pruritus, and respiratory depression, which may impede the recovery process. non-opioid alternatives, however, can improve patient rehabilitation and overall outcomes. the transversus abdominis plane (tap) block efficiently reduces early postoperative discomfort and decreases narcotic usage, which is a significant advantage for patients undergoing inguinal hernia repair. to alleviate pain in the abdominal wall muscles, peritoneum, and skin, this treatment involves administering a local anesthetic into the space between the transversus abdominis and internal oblique muscles.\]2\[

Eligibility criteria:
inclusion criteria: * with asa physical status i or ii * scheduled for elective unilateral inguinal hernioplasty under spinal anesthesia * aged 18 to 60 years * both genders exclusion criteria: patient refusal, bmi ≥ 40 kg/m2 incapacity to engage in pain assessment contraindications to spinal anesthesia (e.g., coagulopathy, skin infection) - and intolerance to the research medications.
post marketing surveillance of remicade

Conditions: Crohn's Disease; Ankylosing Spondylitis

Summary: the purpose of this study is to understand the safety and effectiveness of infliximab when used in clinical practice. this is a post-marketing surveillance study.

the investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on remicade approval.

Eligibility criteria:
inclusion criteria: * severe active crohn's disease: the patients with severe active crohn's disease who do not show any response to the treatment with corticosteroid or immunosuppressive agents, have no drug tolerance, or are contraindicated to such treatments. * fistula-type active crohn's disease: the patients with fistula-type active crohn's disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant. * ankylosing spondylitis: the patients with ankylosing spondylitis who do not show adequate response to general treatments, and with increased serological indices related to severe axial symptoms and inflammation. exclusion criteria: * none

Keywords: crohn's disease ankylosing spondylitis
improving blood pressure control through the mybpmylife mhealth application

Conditions: Hypertension

Summary: this study is enrolling eligible participants that have high blood pressure. reducing dietary salt intake and engaging in regular physical activity is known to decrease blood pressure in people with hypertension. this trial will determine whether a smartwatch and a mobile health application, which together deliver notifications, can increase activity levels and reduce salt intake for people with high blood pressure. all study activities will be completed online or via a mobile medical application. participants will not have any face-to-face visits with the study team.


Eligibility criteria:
inclusion criteria: * self-reported history of hypertension and no hypertensive medication changes in the last 4 weeks. * a smartphone with a compatible apple or android operating system installed and able to download and use the mybpmylife app including accepting all permissions * a valid email address * fluent in spoken and written english * signed written informed consent. (note that each participant must be able to consent for themselves.) exclusion criteria: * contraindication to performing physical activity or following a sodium restriction diet. the participant must be able to walk and eat on their own without assistive devices. * unstable symptoms or markedly elevated bp at enrollment (defined as systolic bp\>180 mmhg, diastolic bp\>120 millimeters of mercury (mmhg)) * known secondary causes of hypertension (e.g., adrenal insufficiency, pheochromocytoma), heart failure, or end-stage renal disease * difficulty using an upper arm blood pressure cuff due to biceps size or end-stage renal disease or difficulty comfortably wearing a smartwatch * wrist too large to wear a smartwatch comfortably. * daily sodium intake less than 1500 mg/day as measured by the sodium screener * currently pregnant or planning to become pregnant in the next six months

Keywords: high blood pressure exercise decrease salty food smartwatch mobile application
the effect of loop diuretics on severity and outcome of acute kidney injury

Conditions: Acute Kidney Failure

Summary: the primary objective is to safely determine if the investigators can identify the severity of acute kidney injury (aki) early in the course of the disease. once enrolled the investigators will draw blood and urine for novel and standard biomarkers. the investigators are attempting to determine if these biomarkers can forecast the course of aki (need for dialysis, death and renal recovery). the investigators seek to determine how well physicians caring for those with aki can predict the clinical course compared to these novel biomarkers of aki and if there is an association between clinical course and 3 year patient outcomes.

aki is a very common disease in the setting of critical illness and carries an extremely high morbidity and mortality rate (over 50%). currently there are no fda approved therapeutic agents for the treatment of aki. there is limited prospective evidence to guide nephrologists in terms of which patients will progress to more severe aki in the setting of early aki. similarly, there is no evidence to guide nephrologists in terms of which patients will completely recover their renal function after aki. thus we need to know very early in the course of aki which patients will progress and go on to require renal replacement therapy (rrt). additionally we will investigating the long term patient outcomes, 2-3 years after the index aki admission.

Eligibility criteria:
inclusion criteria: 1. 18 yrs or older 2. increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater than or equal to 150% from baseline or sustained oliguria (uop \< 0.5 cc/kg/hr for 6 hours with the last 48hours) 3. written informed consent 4. patients with an indwelling bladder catheter exclusion criteria: 1. voluntary refusal 2. patients with advanced chronic kidney disease - as defined by a baseline glomerular filtration rate (gfr) \< 30 ml/min (mdrd) 3. history of renal transplant 4. pregnant patients 5. allergy / sensitivity to loop diuretics (furosemide) 6. pre-renal aki * defined by a fractional excretion of sodium (fena) of \< 1% and no urinary casts * under-resuscitated as per the treating clinical team * active bleed 7. post renal aki * evidence of hydro-ureter * clinical scenario wherein obstruction is considered a likely possibility

Keywords: renal replacement therapy diuretics biomarkers renal insufficiency furosemide therapeutic uses physiological effects of drugs biological markers
the lean meats mediterranean diet study

Conditions: Cardiovascular Diseases; Dietary Modification

Summary: the purpose of the proposed research study is to assess the effects of including greater amounts of minimally processed red meat (lean pork and beef) into a mediterranean diet on cardiometabolic and emotional well-being.

all subjects will complete an 18-wk randomized crossover study. following a 2-wk baseline testing period to assess cardiometabolic and emotional well-being and habitual diet, subjects will consume a mediterranean-style, weight-maintenance diet that is either restricted or rich in lean, minimally processed red meat for 5 weeks. following a 4-wk washout period and second 2-wk baseline testing, subjects will consume the mediterranean diet with the alternate predominant animal protein sources for 5 weeks. cardiometabolic and emotional well-being will be assessed during baseline and post periods.

Eligibility criteria:
inclusion criteria: * male or female 30-69 years old * bmi 25-37 kg/m2 * total cholesterol \<240 mg/dl * low-density lipoprotein \<160 mg/dl * triglycerides \<400 mg/dl * fasting glucose \<110 mg/dl * systolic blood pressure \<160 mmhg * diastolic blood pressure \<100 mmhg * body weight \<300 lb * weight stable for 3 months prior (±10 lb) * stable physical activity regimen 3 months prior ≤3 h/wk of moderate or high intensity exercise resistance or aerobic training * medication use stable for 6 months prior. exclusion criteria: * diabetic * smoker

Keywords: cardiovascular disease risk mediterranean diet red meat
promoting cancer symptom management in older adults

Conditions: Neoplasms; Chemotherapy-induced Nausea and Vomiting

Summary: the purpose of the project is to estimate the effect size of a technology based intervention for older adults with cancer for nausea and vomiting. participants will be randomized to either an intervention or a wait control group. outcomes such as symptom severity, quality of life and resource use will be examined.

the goal of this study is to increase the self-management behaviors for chemotherapy induced nausea and vomiting (cinv) and reduce treatment-related negative outcomes in older adults with cancer. cinv is a common reason for unplanned emergency department and/or hospital admissions in older adults with cancer. early reinforcement of standard education and reframing preconceived beliefs about the potential serious consequences of cinv and the symptoms ability to be successfully managed will increase effective self-management behaviors and improve patient outcomes

Eligibility criteria:
inclusion criteria: * men and women age 65 and older * newly diagnosed with any cancer * treatment with any chemotherapeutic agent with a moderate to severe emetic potential (on a 3- or 4- week cycle) * proficient in english * have a telephone. exclusion criteria: * patients with previous diagnosis and treatment for cancer * advanced or end stage disease with a palliative intent * visually or hearing impaired.

Keywords: gerontology symptom self-management chemotherapy-induced nausea and vomiting