Kornimate/medical-research-clean huggingface dataset:
cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial ibcsg-1-98

Conditions: Breast Cancer; Cognitive/Functional Effects; Fatigue; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: studying cognitive function, such as thinking, attention, concentration, and memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve quality of life and the ability to plan treatment for cancer. purpose: this phase iii trial is studying cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial ibcsg-1-98.

objectives: primary * compare cognitive function in postmenopausal women with breast cancer who have received 5 years of adjuvant tamoxifen vs letrozole on protocol ibcsg-1-98. secondary * compare cognitive function in patients who have received a single hormonal therapy for 5 years vs those who have received that same hormonal therapy for 3 years, having previously received an alternate hormonal therapy for 2 years. * compare improvement in cognitive function 1 year after cessation of adjuvant hormonal therapy. * compare changes in cognitive function in patients who have received prior adjuvant chemotherapy vs those who have not received adjuvant chemotherapy. * assess the relationship between objective and subjective measures of cognitive function, including specific cognitive domains. * assess the relationship between cognitive function and psychological distress, fatigue, and quality of life. outline: this is a longitudinal, multicenter study. patients undergo cognitive function testing and complete self-reported questionnaires regarding cognitive ability, quality of life, fatigue, and psychosocial status during the fifth year of adjuvant hormonal therapy on protocol ibcsg-1-98 and then during the sixth year\* (post randomization on protocol ibcsg-1-98) (i.e., after completion of adjuvant hormonal therapy). note: \*patients who receive extended letrozole, hormone replacement therapy, or other endocrine therapy beyond 5 years do not undergo the 6-year assessment. projected accrual: a total of 148 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * enrolled in protocol ibcsg-1-98 * must be in the fifth year of study treatment (i.e., still receiving tamoxifen or letrozole) * no breast cancer recurrence or second malignancy * patients who received 2-4½ years of tamoxifen and have chosen to switch to letrozole to complete 5 years of treatment on protocol ibcsg-1-98 are not eligible * hormone receptor status * estrogen receptor- and/or progesterone receptor-positive tumor patient characteristics: * female * postmenopausal prior concurrent therapy: * see disease characteristics * no concurrent hormone replacement therapy

Keywords: cognitive/functional effects fatigue psychosocial effects of cancer and its treatment stage i breast cancer stage ii breast cancer stage iiia breast cancer
effect of transcranial direct current stimulation (tdcs) on post-stroke patients on neuromotor recovery

Conditions: Stroke

Summary: the aim of the study is to evaluate whether a non-invasive brain stimulation technique (transcranial direct current stimulation) can influence the secondary neurodegeneration observed after a stroke (assessed based on serum concentration of neurofilaments) and can improve the functional outcome.

the present preliminary study aims to evaluate the effects of tdcs (transcranial direct current stimulation) on functional recovery in subacute stroke patients and on neurodegeneration, measuring neurofilament light chain (nfl) in blood. it will evaluate: * baseline nfl levels in patients with subacute stroke; * the correlation between motor recovery and the blood concentration of nfl in subjects treated with tdcs compared to the control group. * the effect of tdcs on motor recovery and nfl levels in the 3 months after the stroke event;

Eligibility criteria:
inclusion criteria: * partecipants with a first episode of ischemic or hemorrhagic stroke * partecipants must be enrolled within 30 days from the stroke exclusion criteria: * partecipants with previous episodes of ischemic or hemorrhagic stroke (evaluation by neuroimaging required) * uncooperative patients * medically unstable patients * partecipants with any other neurodegenerative diseases * epilepsies * multiple ischemic lesions * encephalic trunk ischemic lesions

Keywords: stroke rehabilitation tdcs neurofilament neurofilament light chain nfl transcranial direct current stimulation
sodium-restricted diets and symptoms in end stage renal disease: an rct

Conditions: ESRD

Summary: dietary sodium intake independently increases the risk of mortality in end stage renal disease (esrd). it plays a significant role in hypertension, hypervolemia, and left ventricular hypertrophy (lvh), and blunts the effectiveness of hypertensive agents. in addition, the hypervolemia associated with excessive dietary sodium intake results in the need for more intense fluid removal during dialysis (ultrafiltration), resulting in symptoms such as pain, cramps, hypotension, nausea, and vomiting during hemodialysis (hd) treatment sessions. although sodium restriction is a universal recommendation for esrd management, the national kidney foundation (nkf) recommendation of 2400 mg/day is consensus-based per the dietary approaches to stop hypertension (dash) studies, not an evidence-based recommendation from data derived from a dialysis population. in addition, the dietary guidelines for americans 2010, recommend further restriction of dietary sodium intake to 1500 mg per day for persons with hypertension and/or kidney disease, middle-aged and older adults, and african americans, though there is also little empiric evidence to support this recommendation in the general population and none in the dialysis population. therefore, it remains to be demonstrated that a diet with such sodium restrictions is attainable, sustainable, safe or beneficial. the investigators propose a double blind randomized controlled design investigation to examine the feasibility of assessing the effects of three levels of sodium intake (ambient, 2400 mg/d, 1500 mg/d) on the hemodialysis (hd) participant symptom profile, and to compare the effect of hemodialysis-specific variables on participant symptom profile during dialysis as well as to explore the role of body fluid composition using bioimpedance (bia) measurements among the three sodium-restricted groups as a marker of sodium restriction efficacy.


Eligibility criteria:
inclusion criteria: 1. persons ≥ 21 years of age 2. who have the ability to read and write, 3. who are undergoing maintenance hd 4. who are on therapy for at least 3 months. exclusion criteria: 1. unable to read or write 2. non-english speaking 3. intend to move out of the area or change hd centers within 6 months 4. have terminal illness or life expectancy of less than 12 months, 5. plan to receive a living donor transplant in the study period, have cognitive impairment 6. are unable to provide informed consent 7. have heart failure class iii or iv 8. have an internal defibrillator or pacemaker, and/or are pregnant.
use of intravitreal bevacizumab in patients with diffuse diabetic macular edema

Conditions: Diabetes Mellitus Type 2; Diabetic Macular Edema

Summary: intravitreal bevacizumab is an effective treatment for the diffuse diabetic macular edema

a non-randomized prospective clinical interventional study which includes 45 non previously treated patients with dme. the patients received a single intravitreal injection of 2.5 mg bevacizumab. follow-up included clinical examination (best corrected visual acuity (bcva, intraocular pressure (iop), cataract grading, dme characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. oct and fluorescein angiography was evaluated at months 1 and 3.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * macular edema involving the center of the macula demonstrated on oct * clear ocular media * untreated patients * older than 45 years * bcva of the fellow eye at least 20/100 exclusion criteria: * renal diabetic disease, uncontrolled hypertension or stroke history * other ocular disease * ocular surgery excepting uncomplicated phacoemulsification * history of photocoagulation (panretinal or focal) * history of another intravitreal treatment (like triamcinolone)

Keywords: diffuse diabetic macular edema intravitreal bevacizumab anti-vegf drugs
intervention to increase chemotherapy tolerance in elderly cancer patients

Conditions: Colonic Neoplasms

Summary: the purpose of this study is to develop and pilot test a behavioral intervention for elderly adults in treatment for colon cancer, to enhance their skills for managing the challenges of completing chemotherapy regimens. the investigators will assess feasibility and acceptability of the intervention, and explore preliminary efficacy of the intervention for reducing psychological distress and improving rates of optimal chemotherapy adherence.


Eligibility criteria:
inclusion criteria: * age 60 or older * verbal fluency in english * diagnosis of colon cancer * scheduled to initiate chemotherapy treatment for colon cancer exclusion criteria: * active, unstable, untreated serious mental illness interfering with ability to participate * cognitive impairment interfering with ability to participate * receiving radiotherapy concomitant with chemotherapy

Keywords: colonic neoplasms older adults psychosocial intervention chemotherapy adherence
carboplatin auc-10 with early pet scanning in metastatic seminoma

Conditions: Metastatic Seminoma

Summary: this study evaluated the safety, efficacy and toxicity of carboplatin area under the curve (auc)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (fdg) positron emission tomography-computed tomography (pet-ct) to assess metabolic response, the number of patients requiring 4 cycles can be reduced. carboplatin auc-10 was given every 21 days. a pet-ct scan was carried out on day 17-21 of the first cycle. if the pet - ct scan showed a complete response patients received 3 cycles of treatment. if the pet - ct scan did not show a complete response patients received 4 cycles of treatment. after treatment, patients were followed up for 2 years.


Eligibility criteria:
inclusion criteria: 1. metastatic seminoma with international germ cell consensus classification (igcccg) good prognosis. 2. glomerular filtration rate (gfr) by ethylenediaminetetraacetic acid (edta) clearance over 25 ml/min. 3. eastern cooperative oncology group (ecog) performance status 0-3. 4. normal alpha-fetoprotein (all levels of human chorionic gonadotropin and lactate dehydrogenase are acceptable). 5. males aged ≥18 and ≤75 years. 6. able to give written informed consent prior to study entry. 7. patients must be sterile or agree to use adequate contraception during the period of therapy. exclusion criteria: 1. metastatic seminoma with any non-pulmonary visceral metastases. 2. raised alpha-fetoprotein. 3. any previous chemotherapy or radiotherapy. 4. currently enrolled in any other investigational drug study. 5. other malignancy except basal cell.
phase ⅱ study of neoadjuvant chemotherapy followed by concurrent chemoradiation for stage ⅳab nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the primary objective of this study is to determine the tolerance and overall survival in patients with stage ⅳab npc treated with neoadjuvant chemotherapy and concurrent chemoradiation. secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage ⅳab treated with this regimen

concurrent chemoradiation is the standard treatment for locally advanced npc. the survival benefit gained from adding neoadjuvant chemotherapy to concurrent chemoradiation has never been defined. in the present trail, we hope to assess the tolerance and survival benefits of neoadjuvant chemotherapy followed by concurrent chemoradiation in patients with stage ⅳab npc.

Eligibility criteria:
inclusion criteria: * histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx. * stage ⅳab disease * kps \>70 * age between 18-70 * patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (agc) of \> 2000 cells/mm3, platelet count of \> 100,000 cells/mm3 (pre treatment without intervention). bilirubin \ 50ml/min. * no prior radiation treatment to the head and neck or any prior chemotherapy * patients with no prior malignancy (not include basal cell carcinoma of skin) exclusion criteria: * evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. * prior radiotherapy to the head and neck region for any reason. * initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. * patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin. * pregnant women

Keywords: phase 2 clinical trial npc neoadjuvant chemotherapy concurrent chemoradiation
dose-finding, safety, efficacy trial of topical resiquimod in patients with multiple actinic keratosis lesions

Conditions: Actinic Keratosis

Summary: a dose-finding study of resiquimod evaluating safety and efficacy in patients with multiple actinic keratosis lesions

prospective, randomized, partly blinded, in part placebo-controlled, multicenter dose-finding trial with patients suffering from ak. patients were observed for efficacy, local tolerability and safety. a total of 14 sites in switzerland and germany enrolled male and female patients over 18 years of age with clinically diagnosed ak lesions patients were randomized to receive resiquimod gel (treatment arms 1, 2, 3, 4, or 5) or matching vehicle (treatment arms 1-pla, 2-pla, or 3-pla): treatment arms 1, 2 and 3: the patient was randomly assigned to one of three treatment groups and within each group there was one randomly assigned placebo patient for every two treatment patients (parallel-group randomization; 2:1 active vs placebo). treatment arms 4 and 5: the patient was randomly assigned to one of two treatment groups (parallel-group randomization, 1:1).

Eligibility criteria:
inclusion criteria: * signed informed consent * male or nonpregnant, nonlactating female, ≥18 years * a minimum of 2 clinically diagnosed ak-lesions within a defined area (25 cm2 contiguous treatment area). one ak-lesion must have a diameter of at least 6 mm (indicator lesion) * ak-lesions on balding scalp, forehead or face exclusion criteria: * known allergy or hypersensitivity to any of the trial gel ingredients * dermatological disease or condition that might be exacerbated by resiquimod gel treatment or may impair trial assessments * evidence of unstable or uncontrolled clinically significant medical conditions, active infection, immunosuppression or systemic cancer

Keywords: actinic keratosis resiquimod
effect of physiotherapy after total knee replacement

Conditions: Knee Osteoarthritis

Summary: physiotherapy plays an important part in rehabilitation after total knee arthroplasty. even if this is a common practice, few studies have been performed on this issue. the prime aim of this study is to examine the effects of an ambulatory individualized task-oriented exercise program compared with current ambulatory physiotherapy(usual care)on activity performance and self efficacy beliefs in the time span 6 weeks to 3 months after total knee arthroplasty with a follow-up at twelve months. ho:task oriented physiotherapy has better effect than usual care on activity performance and self-efficacy beliefs in the time span 6 weeks to 3 months after total knee replacement.

a randomized controlled trial was performed with an experiment group having task oriented exercises in only weight-bearing 12 times from 6 weeks to 12 weeks after the operation, while the control group had usual physiotherapy care during the same time span. the primary outcome was walking measured by the six minutes walk test. other performed and self reported measures of physical functioning were performed, at baseline, six weeks after the operation, immediately after the intervention at 12-14 weeks and with a follow-up nine months after the intervention.

Eligibility criteria:
inclusion criteria: * primary gonarthrosis * good written and oral understanding of norwegian * good cognitive function exclusion criteria: * severe gonarthrosis in the other knee or coxarthrosis * neurological disorders or rheumatoid arthritis

Keywords: physiotherapy functional outcome activity level self efficacy task oriented exercises
a pilot study to develop predictive biomarkers for the response to immunotherapy in lung cancer

Conditions: Lung Cancer

Summary: several immune checkpoint inhibitors targeting the pd-1 pathway have been developed with clinical trials showing an approximately 20% durable response in unselected patients with advanced non-small cell lung cancer (nsclc). at the moment, no clear biomarker exists to accurately predict anti-pd1/pdl1 tumor responsiveness. the goal of this study is to broadly discover and evaluate the utility of blood based biomarkers for use in measuring and predicting response to immunotherapy in patients with lung cancer.


Eligibility criteria:
inclusion criteria: * advanced metastatic nsclc * scheduled to initiate an immune checkpoint inhibitor * age \>= 18 years * able to provide informed consent exclusion criteria: * other, unrelated, concomitant active, invasive malignancy
regulation and signaling of red blood cell (rbc) endothelial nitric oxide synthase (enos) in patients with stable and unstable coronary artery disease

Conditions: Coronary Artery Disease; Endothelial NO-synthase

Summary: the aim of this study is measurement of expression and activity of rbc enos in different clinical cohorts of patients with coronary artery disease and acute coronary syndrome and to investigate the importance of the no-stimulated reaction cascade in terms of sgc and pkg.


Eligibility criteria:
inclusion criteria: * informed consent * for acs(acute coronary syndrome)-group: angiographic coronary artery disease; acute coronary syndrome, defined by either unstable angina pectoris with significant coronary stenosis (troponin negative, without significant st-elevation) or low-risk nstemi (troponin positive, without significant st-elevation) * for stable cad-group: angiographic coronary artery disease; no acute coronary syndrome within the last 3 months * healthy control group: no clinical or angiographical signs of apparent atherosclerosis exclusion criteria: * acute inflammation (crp \> 1 mg/dl, leukocyte \> 11.000/µl) * malignant diseases * pregnancy * medication with no-donors ( e.g.isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate, molsidomin, ranexa) * patients with stemi or high-risk nstemi

Keywords: coronary artery disease acute coronary syndrome angina pectoris non-st-segment elevation myocardial infarction red blood cells erythrocytes
gemcitabine in treating patients with recurrent or refractory cancer of the uterus

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus.

objectives: i. determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. ii. determine the toxicity of gemcitabine in these patients. outline: patients receive gemcitabine iv over 30 minutes weekly for 3 weeks. courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. patients are followed every 3 months for 2 years, then every 6 months for 3 years. projected accrual: a total of 40 patients will be accrued for this study within 4 years.

Eligibility criteria:
disease characteristics: histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or standard treatments failed local therapeutic measures and considered incurable measurable disease not eligible for a higher priority gog protocol patient characteristics: age: 18 and over performance status: gog 0-2 life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 platelet count at least 100,000/mm3 granulocyte count at least 1,500/mm3 hepatic: bilirubin no greater than 1.5 times normal sgot no greater than 3 times normal alkaline phosphatase no greater than 3 times normal renal: creatinine no greater than 1.5 mg/dl other: no significant infection at least 5 years since any other invasive malignancy except nonmelanoma skin cancer prior concurrent therapy: biologic therapy: at least 3 weeks since prior biologic therapy chemotherapy: at least 3 weeks since prior chemotherapy and recovered no prior gemcitabine no more than 1 prior chemotherapy regimen (single agent or combination therapy) endocrine therapy: at least 3 weeks since prior endocrine therapy radiotherapy: at least 3 weeks since prior radiotherapy and recovered surgery: at least 3 weeks since prior surgery and recovered

Keywords: recurrent uterine sarcoma uterine leiomyosarcoma
pediatric fast fluid randomized controlled trial

Conditions: Fluid Resuscitation

Summary: the purpose of this study is to determine the impact of syringe size on the amount of time it takes a health care provider to administer a known volume (900 ml) of resuscitation fluid to a non-clinical, toddler-sized, model. the investigators hypothesize that syringe size will impact fluid resuscitation time.

the surviving sepsis guideline for the resuscitation of pediatric septic shock indicates that up to 60 ml/kg of isotonic saline should be administered within the first 15 minutes of resuscitation. there are practical challenges to achieving these benchmarks. syringes are often used to perform manual fluid resuscitation as they are generally available and health care providers are typically comfortable using them. health care providers have been observed to have different preferences regarding the syringe size used to perform manual fluid resuscitation. larger syringes e.g. 60 ml-size requires more force to depress the syringe plunger, due to a larger crosssectional area, but fewer syringes are needed to administer a given volume. fewer syringes results in less time spent connecting and disconnecting syringes, which contributes to total fluid resuscitation time using this technique. consenting participants will be randomly assigned (by an independent randomization coordinator) to one of four syringe size groups (10 ml, 20 ml, 30 ml, 60 ml sizes). the allocation sequence is therefore concealed. after undergoing a standardization procedure, each participant will be instructed to administer 900 ml of 0.9% normal saline using pre-filled provided syringes by manual push as rapidly as possible using the disconnect-reconnect method. participants will be advised to consider that they are in a situation where they are resuscitating a 15 kg child (represented by the model) in decompensated shock. syringes for each 300 ml (20 ml/kg) aliquot will be colour-coded for identification purposes.

Eligibility criteria:
inclusion criteria: * consenting health care staff and health care students capable of performing manual syringe bolus fluid administration exclusion criteria: * non-english speaking individuals * any condition that would impact upon the individual's ability to perform manual fluid resuscitation e.g. limited hand strength or dexterity

Keywords: pediatrics fluid bolus resuscitation shock