Kornimate/medical-research-clean huggingface dataset:
studying blood and dna samples from patients with breast cancer treated with chemotherapy with or without trastuzumab

Conditions: Breast Cancer

Summary: rationale: studying samples of blood and dna in the laboratory from patients who received chemotherapy with or without trastuzumab may help doctors learn more about the effects of trastuzumab on cells. it may also help doctors understand how well patients respond to treatment. purpose: this research trial studies blood and dna samples from patients with breast cancer treated with chemotherapy with or without trastuzumab.

objectives: * to determine the role of trastuzumab in the generation of her2-specific antibodies in breast cancer patients undergoing adjuvant combination therapy. * to determine whether the improved disease-free period and overall survival of patients treated in the adjuvant setting with combination of chemotherapy and trastuzumab is dependent on the fcγ receptor genotype of the patient. outline: previously collected serum and dna samples are analyzed for her2-specific antibodies and fcγr genotype by enzyme-linked immunosorbent assay (elisa) and polymerase chain reaction (pcr).

Eligibility criteria:
• patients with her-2-overexpressing node-positive or high-risk node-negative breast cancer enrolled on ncctg-n9831 \* pre- and post-treatment serum and dna samples of patients treated with doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (herceptin®)

Keywords: her2-positive breast cancer her2-negative breast cancer stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer
internetbased relapse prevention for partially remitted depression

Conditions: Depression

Summary: the main purpose of the study is to test whether internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education. we hypothesise that during the two years following the intervention: * the persons in the group receiving internet-based relapse prevention plus medication will be absent from work for fewer days due to sick-leave compared to those in the medication-only group. * fewer persons in the group receiving internet-based relapse prevention + medication will experience long term sick-leave (60 days or more) compared to those in the medication-only group. * the persons in the group receiving internet-based relapse prevention plus medication will suffer fewer depressive relapses compared to those in the medication-only group. * at follow-up, the persons in the group receiving internet-based relapse prevention plus medication will have higher health related quality of life and lower levels of depressive symptoms compared to those in the medication-only group.


Eligibility criteria:
inclusion criteria: * mild residual depressive symptoms (7-19 on the madrs-s). * a history of at least one episode of major depression. * currently in (at least) half-time employment, self-employment or education. * taking a stable (since one month) and therapeutic dosage of antidepressant medication * being able to read and write swedish * having access to the internet exclusion criteria: * fulfilling the criteria for major depression * psychosis * substance abuse * suicidality

Keywords: relapse, recurrence, depression, internet, sick-leave
swedish drug-elution trial in peripheral arterial disease

Conditions: Peripheral Arterial Disease; Critical Limb Ischemia; Intermittent Claudication

Summary: peripheral arterial disease (pad) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. symptoms of pad range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. invasive treatments are often indicated to prevent amputations and to alleviate symptoms. more than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, pta with or without stent implantation). in coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, des) reduce restenosis and improve clinical results for the majority of patients. drug eluting balloons (deb) are a promising alternative, but there is still little evidence that des or deb technology improve clinical outcome in pad. however, promising results utilizing these new technologies in pad have been reported in a few studies. in this trial, we test the hypothesis that drug eluting (de) technology is superior to conventional endovascular treatment (no-de) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. the trial consists of 2 separate parallel studies, swedepad 1 and swedepad 2, each defined by the severity of peripheral arterial disease. patients with critical limb ischemia are allocated to swedepad 1 and patients with intermittent claudication are allocated to swedepad 2.


Eligibility criteria:
inclusion criteria: * all adults \> 18 years old willing to be randomized * symptomatic pad (critical limb ischemia or intermittent claudication) caused by \>50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications exclusion criteria: * acute thromboembolic disease in the leg * infrainguinal aneurysmal disease * previous participation in the study or in other randomised interventional study of infrainguinal lesions * patients without a swedish personal identification number

Keywords: critical limb ischemia intermittent claudication endovascular treatment drug-elution
sacrospinous ligament fixation and lateral suspension operations

Conditions: Prolapse; Cuff

Summary: different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. one of these is transvaginal sacrospinous ligament fixation and the other is lateral suspension. the investigators want to compare the results of patients undergoing these two operations. thus, the difference between surgical methods will be investigated.

patients with symptomatic vaginal cuff prolapse will be operated; there will be two kinds of operation. after the operations, the patients will be followed up, a questionnaire will be applied to the postoperative patients and some questions will be asked. pelvic examinations will also be performed and they will be evaluated for recurrence and complication. at the end of the study, the data of both groups will be compared and their superiority to each other will be shown.

Eligibility criteria:
inclusion criteria: * patients who had previously undergone hysterectomy for benign causes * patients with symptomatic vaginal cuff prolapse during hysterectomy follow-up * and for this, patients scheduled for operation exclusion criteria: * patients with chronic diseases or medications that interfere with the operation * patients with oncology operated for malignant cause * non-localized patients with vaginal cuff prolapse
single fraction intraoperative radiotherapy

Conditions: Invasive Ductal and Invasive Lobular Breast Carcinoma; Stage 0 Breast Carcinoma; Stage I Breast Carcinoma; Stage II Breast Carcinoma

Summary: this clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. this single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.

for patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it) followed by breast radiation. the radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. during this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.

Eligibility criteria:
inclusion criteria: * histological proven invasive breast carcinoma ductal, lobular and/or ductal carcinoma in situ * age \> 40 years * karnofsky performance status \> 70% * tumor. single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm * nodal status: preoperatively n0 * clear surgical margins: r0 * all grades g1 - g3 * any hormonal receptor and her-2 status * informed consent exclusion criteria: * gender: male * tumor size: more than 2.5 cm * nodal status greater than or equal to n1 pathologically * multicentricity * previous radiotherapy to the involved breast * karnofsky index \< 70% * mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus * distant metastases * pregnancy in woman of child bearing age * unable to provide written consent

Keywords: breast cancer carcinoma radiotherapy intraoperative radiotherapy iort
immune response features in allergic airway diseases

Conditions: Allergic Rhinitis; Allergic Asthma

Summary: this study aims to investigate immune mechanisms and phenotypes and endotypes of allergic airway diseases - allergic rhinitis and allergic asthma. pathogenesis of these diseases are not fully investigated yet. patients with the same disease have different dominant symptoms, course of the disease and response to treatment. moreover, there is a hypothesis about united airway disease suggesting that allergic rhinitis and allergic asthma is different manifestation of the same disease. this led to assumption of phenotypes and endotypes. this classification which still is not unified can let to prescribe personalized treatment for every patient.


Eligibility criteria:
inclusion criteria: * hypersensitivity to house dust mites * allergic rhinitis with or without mild to moderate asthma exclusion criteria: * acute or chronic infections * use of systemic immunosupresants (wait 1 month) * use of systemic or local antihistamines (wait 1 week) * use of intranasal steroids (wait 1 month) * oncological or active autoimmune diseases
body weight, sleep, and heart health

Conditions: Cardiovascular Risk Factor; Circadian Dysregulation; Obesity

Summary: a multidisciplinary investigation examining the circadian mechanisms regulating cardiovascular (cv) risk in obesity. specifically, in a valid circadian protocol, the investigators aim to study resting cardiovascular risk markers and the reactivity of circadian rhythms in these risk markers to standardized stressors in obesity. furthermore, using an ingenious approach, the investigators propose to explore impairment in pre/post synaptic function in the cardiac left ventricle.

overall, these studies will help us answer whether cv rhythms predispose obese individuals to increased cv disease risk - particularly around the vulnerable morning period. the results will serve as a foundation for clinical trials of appropriately timed dosing of medications targeting aspects of the cv system in obesity that increase effectiveness while decreasing side-effects.

Eligibility criteria:
inclusion criteria: * ages 25-65 * lean and overweight (bmi 18.5-40kg/m2) * habitually sedentary exclusion criteria: * history of smoking/tobacco use * insomnia * moderate to severe obstructive sleep apnea. * prior shift work within 6 months prior to the study. * prescription medications * drugs of abuse * acute, chronic, or debilitating medical condition (including diabetes, hypertension, and metabolic syndrome)
intravitreous cytokine level in patient with retinal detachment

Conditions: Retinal Detachment

Summary: photoreceptor apoptosis is the basis for permanent visual loss in a number of retinal disorders including age-related macular degeneration (amd) and retinal detachment (rd). thus, despite tremendous advances in vitreoretinal surgery and management of rhegmatogenous rd leading to a primary reattachment rate over 95%, some patients show poor visual recovery because of photoreceptor apoptosis. physiologically, microglial cells (resident macrophages) are present only in the inner retina. the subretinal space, located between the retinal pigment epithelium (rpe) and the photoreceptor outer segments (pos), is devoid of all mononuclear phagocytes and form a zone of immune privilege. in amd, several studies showed a strong association between subretinal mononuclear phagocytes infiltration and advanced forms of amd. experimental work in mice suggest that this infiltration plays an important role in the pathogenesis of this condition by producing inflammatory cytokines. rd-induced photoreceptor apoptosis might result from similar mechanisms. the aim of this study is to determine the cytokine profile in vitreous samples from patients with rd and to compare it with those from control patients with macular hole.


Eligibility criteria:
inclusion criteria: * patients with primary retinal detachment requiring vitrectomy * patients with idiopathic macular hole requiring vitrectomy exclusion criteria: * history of retinal detachment or intraocular inflammatory diseases

Keywords: retinal detachment photoreceptor apoptosis cytokine
effect of intake of pyrus pyrifolia var. culta(makino) nakai peel extract on body fat and blood lipid.

Conditions: Obesity

Summary: the investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of pyrus pyrifolia var. culta(makino) nakai peel extract on decrement of body fat. the investigators measured decrement of body fat parameters , including body fat mass, percent body fat, weight and bmi(body mass index), and monitored their blood pressure.


Eligibility criteria:
inclusion criteria: * males and females 19-65 years old * bmi(body mass index) 25\~29.9 kg/m\^2 or wc(waist circumference) ≥ 90(men), wc ≥ 85(women) * able to give informed consent exclusion criteria: * bmi(body mass index) ≥ 30 kg/m\^2 * significant variation in weight(more 10%) in the past 3 months * allergic or hypersensitive to any of the ingredients in the test products * history of reaction to any of the test products or of gastrointestinal diseases such as crohn's disease or gastrointestinal surgery * history of alcohol or substance abuse * participation in any other clinical trials within past 2 months * laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * pregnant or lactating women etc.
efficacy and safety of risperidone and trazodone monotherapy and combination therapy in critically ill patients with delirium

Conditions: Delirium; Agitation

Summary: the purpose of this randomized clinical trial is to determine whether risperidone alone, trazodone alone, or a combination of risperidone and trazodone is superior for the treatment of icu acquired delirium. the hypothesis is that combination therapy is superior to either agent alone in treating icu acquired delirium and sustaining delirium free time.

delirium is defined as a disturbance of consciousness characterized by an acute onset of impaired cognitive function. although delirium is thought to be common in the intensive care unit (icu) there are few studies that have evaluated its incidences, risks and outcomes. it has been associated with increased morbidity, and mortality and increased cost to the healthcare system. in addition to the uncertainty of the incidence of icu delirium, there is a lack of information about the effects that certain pharmacological treatments have on delirious patients. the rationale for this study is to evaluate the efficacy and safety of risperidone alone, trazodone alone, and risperidone plus trazodone for the treatment of delirium in critically ill patients when compared to placebo.

Eligibility criteria:
inclusion criteria: * age greater than 18 years old who are admitted for more than 24 hours in the micu or sicu * patients diagnosed with delirium by primary team (screened positive for delirium using the cam-icu or with clinical manifestations of delirium) * patients have an order for as-needed haloperidol or have received a one-time dose of haloperidol within 24 hours of randomization * patients must be tolerating enteral feeding (greater than 20 ml/hour for more than 12 hours) exclusion criteria: * patients who are unlikely to survive 24 hours after admission to the icu * patients who are admitted with a primary neurological condition or injury (i.e. stroke, active seizures, prolonged coma, overdose) * patients who can not actively participate in delirium assessment * patients actively withdrawing from alcohol or narcotics * patients who were treated with any antipsychotic or trazodone within 30 days prior to icu admission * patients with a marked baseline prolongation of the qtc interval (repeated demonstration of qtc interval greater 500 milliseconds (msec)) * patients with a history of torsades de pointes * patients with current treatment with an agent having either the potential to affect or increase the risk of qtc prolongation (e.g. erythromycin, any class ia, ic, or iii antiarrhythmics) * patients being treated with a neuromuscular blocker * patients in whom haloperidol, risperidone, or trazodone is contraindicated * pregnant patients or patients who are breast-feeding * patients with a modified blessed dementia rating scale score ≥4 or an informant questionnaire of cognitive dysfunction in the elderly score ≥4 * patients in which informed consent can not be obtained from the legally authorized representative
evaluation of preoperative oral rehydration solution in colectomy

Conditions: Insulin Resistance; Postoperative Complication

Summary: elective colectomy procedures typically require bowel preparation starting 2 days prior to the surgery. osmotic laxatives such as colyte® are administered 2 days prior, and nothing by mouth (npo) is required 1 day prior to ensure no fecal residue is left in the bowel. though it may ensure a cleaner and safer surgery, this longer period of starvation increases insulin resistance and may increase post-op complications. however, there is evidence that administration of oral rehydration solution(ors) prior to surgery reduces insulin resistance. our purpose is to evaluate the difference of insulin resistance in those who received ors 1 day prior to surgery and those who did not.

1. enhanced recovery after surgery (eras) enhanced recovery after surgery(eras) was introduced in the early 2000s by kehlet et.al., and was applied primarily to patients receiving colectomy. as the knowledge and understanding of this concept continues to grow, we are now able to change the way we treat pre- and post- operative patients. in europe, it has been proven that applying this concept to patients resulted in decreased length of post-operative hospital stay, post-op complications and overall hospital costs. 2. the change in homa-ir with shorter preoperative nothing by mouth (npo) period in eras patients 1. homa-ir index equation (evaluation of insulin resistance) = insulin (μu/ml) x blood glucose (mg/dl) / 405 2. homa-ir was statistically proven to have been lowered in patients who received ors 2hr prior to surgery. 3. reference * increased insulin resistance induces hyperglycemia * toxicity of post-op hyperglycemia and their relation to post-op complications * insulin resistance increases in procedures such as herniorrhaphy or laparoscopic cholecystectomy. administration of preoperative carbohydrates decrease post-op nausea and vomiting * conventional pre-op 8hr fasting increases insulin resistance and influences increased glucose levels 3. additional benefits of shorter preoperative fasting 1. relieve of stress of fasting 2. help stabilize post-op triglyceride, cortisol, and glucose levels 3. reduce infectious complications

Eligibility criteria:
inclusion criteria: * asa grade i\~ii (dm, cva, copd, esrd, mi, tia etc. excluded) * age: adults age 19\~75 * patients undergoing elective colon cancer surgery * able to take the ors per orally. able to swallow without trouble of aspiration tendencies * bmi of less than 27.5 * child-turcotte-pugh classification score of less than 6 exclusion criteria: * emergency cases such as obstruction or perforation * food allergy * abdominal distension at present * prior gastric surgery

Keywords: early recovery after surgery oral rehydration solution insulin resistance postoperative complication
study to compare efficacy and safety of abp 501 and adalimumab (humira®) in adults with moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this research study is to compare the efficacy and safety of abp 501 and adalimumab (humira®) in adults with plaque psoriasis.


Eligibility criteria:
inclusion criteria: 1. men or women ≥ 18 and ≤ 75 years of age at time of screening 2. stable moderate to severe plaque psoriasis for at least 6 months before baseline 3. moderate to severe psoriasis defined at screening and baseline by: body surface area (bsa) affected by plaque psoriasis of 10% or greater, and pasi score of 12 or greater, and static physician's global assessment score of 3 or greater 4. no known history of active tuberculosis 5. subject is a candidate for systemic therapy or phototherapy procedures 6. previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy exclusion criteria: 1. forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema) 2. ongoing use of prohibited treatments 3. prior use of 2 or more biologics for treatment of psoriasis 4. previous receipt of adalimumab or a biosimilar of adalimumab other inclusion/exclusion criteria may apply

Keywords: plaque psoriasis