Kornimate/medical-research-clean huggingface dataset:
a study of pi3-kinase inhibitor gdc-0941 in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole, in participants with locally recurrent or metastatic breast cancer

Conditions: Breast Cancer

Summary: this is an open-label, multicenter, phase ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (po) pictilisib administered with letrozole or intravenous (iv) paclitaxel with and without iv bevacizumab or iv trastuzumab in participants with locally recurrent or metastatic breast cancer. the study consists of three parts. part 1 (pictilisib will be administered in 21+7 schedule along with paclitaxel and/or bevacizumab), part 2 (pictilisib will be administered in 5+2 schedule along with paclitaxel and/or bevacizumab or trastuzumab) and part 3 (pictilisib will be administered in combination with letrozole). part 1 and part 2 consists of two stages; a dose escalation stage and a cohort-expansion stage.


Eligibility criteria:
inclusion criteria: * confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease * adequate organ and bone marrow function as assessed by laboratory tests * evaluable disease or disease measurable per recist * agreement to use an effective form of contraception for the duration of the study exclusion criteria: * history of malabsorption syndrome or other condition that would interfere with enteral absorption * any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents * prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, radiotherapy, or hormonal therapy) within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study treatment * uncontrolled current illness * active small or large intestine inflammation (such as crohn's disease or ulcerative colitis) * clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (hiv), hepatitis b virus, or hepatitis c virus * known hiv infection * new york heart association (nyha) class ii or greater congestive heart failure * active ventricular arrhythmia requiring medication * pregnancy, lactation, or breastfeeding * known significant hypersensitivity to study drugs or excipients * history of arterial thromboembolic disease within 6 months of first study treatment * no more than two prior chemotherapy regimens for metastatic disease

Keywords: mbc pi3k avastin herceptin
effect of nurse-led supportive care on quality of life

Conditions: Quality of Life

Summary: breast cancer is the most common type of cancer in women with a high mortality rate in the world. the several methods are used in the treatment of breast cancer. one or more of these methods can be preferred according to the characteristics of women with breast cancer. women may experience many different physiological and psychological symptoms during each treatment process.this situation negatively affects the quality of life of women with breast cancer. for this reason, there is a need for an intervention that could improve quality of life in women with breast cancer. in the literature, it is stated that nurse-led supportive care can be an effective nursing intervention to improve the quality of life in women with breast cancer.

this an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of nurse-led supportive care on quality of life in women with breast cancer. this trial was conducted in the general surgery clinic of training and research hospital located in turkey. all patients were women who had breast surgery.

Eligibility criteria:
inclusion criteria: * 18 years and older women, * stages ii or iii breast cancer * having breast cancer surgery * planned to receive chemotherapy * able to use a phone * who agreed to participate in the study exclusion criteria: * having communication problems * having psychological diseases * receiving any supportive care

Keywords: nurse-led care quality of life breast cancer
somatropin therapy in children born preterm but appropriate for gestational age

Conditions: Growth Hormone Therapy; Infant, Very Low Birth Weight

Summary: safety and efficacy of somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.


Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: * prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age. * girls: tanner stage 1 breast development * boys: testis volume \<= 3ml * tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition). * (in case of any signs or symptoms of gonadal puberty a gnrh-test must decide if the subject is still pubertal.) * height \<=-2 sd for chronological age (brandt/reinken). * growth velocity sds below 0 sd for chronological age (brandt/reinken based on 12+/- 3 months observation period before screening). * premature born defined as \<=1500 g birth weight. * gh sufficiency (gh level \> 7 ug/l following any routine gh stimulation test). * written informed consent of both parents (legal guardians) and oral/written consent of subject due to age specific information. exclusion criteria: subjects presenting with any of the following will not be included in the trial: * other endocrine diseases except for well substituted hypothyroidism. * severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. glucocorticoids). * positive gad and ia-2 antibodies (for type 1 diabetes). * history of malignancy * children who meet all of the following 4 criteria: * actual body height \< -2,5 sds (brandt/reinken) and parent adjusted target height \< -1 sds (hermanussen and cole, 2003) * length and/or body weight retardations adjusted to gestational age at birth \< -2,0 sds (lawrence et al., 1989, voigt et al., 1996) * children with chronological age \> = 4 years and * growth velocity \< 0 sds during the last year before inclusion. * chromosomal aberrations or syndromes. * suspected non-compliance or impossibility to follow the two or three year treatment schedule, respectively (e.g. social implications). * severe hemiparesis and severe cns defects * retinopathia \> third degree or laser treatment as newborns. * participation in any other clinical trial during active treatment phase. * other severe acute or chronic medical or psychiatric condition or clinically relevant laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
improving the quality of dementia care through innovative redesign of the memory care environment

Conditions: Dementia

Summary: research study is being done to demonstrate novel opportunities to transform the way the dementia community is cared for.


Eligibility criteria:
inclusion criteria: * patients currently residing at arbor terrace memory care unit * patients diagnosed with dementia exclusion criteria: * hospice patients with less than 30 days of life expectancy at the time of enrollment
pre-epidural sequential compression devices (scds) to prevent hypotension during labor

Conditions: Hypotension; Labor Complication

Summary: when hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. the purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of scds in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. this study will use a randomized, non-blinded, controlled design with two arms: * arm 1: patient will receive 1l of lr and have scds applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement * arm 2: patient will receive 1l of lr during and after epidural placement with no use of scds

when hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. the purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of scds in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. this study will use a randomized, non-blinded, controlled design with two arms: * arm 1: patient will receive 1liter (l) of lactated ringers (lr) and have scds applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement * arm 2: patient will receive 1l of lr during and after epidural placement with no use of scds outcome variables include occurrence of maternal hypotension or category ii fetal tracings in the first hour after epidural placement.

Eligibility criteria:
inclusion criteria: * laboring at bethesda north hospital labor \& delivery unit * will receive epidural analgesia * 37+ weeks gestation * singleton pregnancy * category 1 tracings only before epidural placement exclusion criteria: * under 18 years old * does not speak english * unable to consent to involvement in the research study * diagnosed with fetal demise * diagnosis of pre-existing hypertension * diagnosis of gestational hypertension * diagnosis of pre-eclampsia * diagnosis of diabetes * breech presentation * contraindications to lower leg compression (ex: fractured bones in leg, cellulitis, lower limb amputation, etc.) * contraindications to receiving 1l of lr * blood pressure on admission systolic blood pressure (sbp)\>160 or diastolic blood pressure (dbp)\>110 * fetal heart rate abnormalities before epidural
predicting successful outcome of interdisciplinary biopsychosocial rehabilitation in osteoarthritis

Conditions: Chronic Pain; Osteoarthritis; Disability Physical

Summary: the goal of this prospective study is to identify variables that can predict whether an interdisciplinary biopsychosocial intervention for patients with osteoarthritis will be successful. using an observational design, patients admitted to this program during the 3-year period (2019-2021) will be included and data gathered during routine clinical practice at baseline and end of treatment of patients who gave informed consent, will be used. with these data a prediction model will be build and internal validation with bootstrapping will be done.

rationale: to predict the probability of a positive outcome of interdisciplinary biopsychosocial intervention in individual patients with osteoarthritis (oa), a prediction model is needed. research question/objective: the overall goal is to develop a clinical prediction model to facilitate decision making in interdisciplinary biopsychosocial rehabilitation in patients with oa. the model will predict the individual probability (in percentage) of a positive response to the treatment (treatment success). design: a retrospective cohort design. setting: a dutch rehabilitation facility. participants: patients with oa diagnosed by a medical specialist and consisting at least three months. intervention and procedures: the intervention of interest is interdisciplinary biopsychosocial rehabilitation. the procedures include the development of a clinical prediction model and assessment of its performance and internal validity. measurements: candidate predictors will be carefully selected. the outcome of the model will be treatment success, defined by the change on the pain disability index (pdi). the model will be built with data gathered as part of routine practice. expected outcome of the research: the deliverable will be a clinical predication model, which can be used in follow-up research.

Eligibility criteria:
inclusion criteria: * chronic musculoskeletal pain \> 3 months and osteoarthritis * large personal and social dysfunction * interplay of biological, social and psychological factors maintaining pain and/or disability exclusion criteria: * inability to actively participate in treatment (insufficient motivation, limited dutch language skills, environmental factors, other pending treatments) * disagreement between patient and care providers on content of treatment * pending legal procedures that hinder full cooperation

Keywords: multimodal treatment interdisciplinary rehabilitation medicine prediction model treatment outcome
carbohydrate restricted diet intervention for men on prostate cancer active surveillance

Conditions: Prostate Cancer

Summary: this phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on active surveillance. eligible patients include men over 18 years old, bmi \>25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on as. arms of the trial will be randomized 1:1 in a crossover approach, with arm a receiving a carb restricted diet over 6 months then soc and arm b receiving the waitlist control arm (i.e. soc then allowed to go on diet after 6 months). ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month soc biopsy. every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.


Eligibility criteria:
inclusion criteria: * pathologically confirmed prostate adenocarcinoma * most recent biopsy positive for prostate cancer * currently on or starting active surveillance * ability to read, write, and understand english * bmi \>24 kg/m2 * written informed consent obtained from subject and ability for subject to comply with the requirements of the study. * scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer * age \> 18 years exclusion criteria: * already consuming a severely carbohydrate-restricted (i.e. \<20g total carbohydrates per day) or vegetarian diet * medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study * anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy) * loss of \>10% of body weight within the previous 6 months * currently receiving any oral hormonal therapy for prostate cancer or bph (finasteride, dutasteride, bicalutamide) * if prior oral hormonal therapy use for prostate cancer or bph (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications) * having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (lhrh agonist, lhrh antagonists, prostvax, provenge) * current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program

Keywords: prostate cancer prostate adenocarcinoma active surveillance diet weight loss low carb ketogenic diet ketogenic
efficacy and safety of colistin for therapy of infections caused by esbl producing k.pneumoniae or e.coli

Conditions: Infections

Summary: in patients with documented esbl-producing e.coli and klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.

in patients with documented esbl-producing e.coli and klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.the primary outcome is clinical response and secondary outcomes are microbiological response and adverse events.

Eligibility criteria:
inclusion criteria: * age \> 18 yr. * hospitalized to siriraj hospital * infections with esbl-producing e.coli or k.pneumoniae * consent informed consent exclusion criteria: * pregnancy or lactating mother * colistin allergy * neurologic diseases

Keywords: esbl-producing e.coli infections esbl-producing klebsiella pneumoniae infections colistin
experimental study about physiotherapy treatment vs self-treatment in axillary web syndrome after axillary dissection

Conditions: Breast Neoplasms

Summary: background dissection and removal of lymph nodes in the axilla (alnd) remains a method used in breast cancer management across the world. post- surgical scar tissue that forms in this dissection is therefore beyond the linear scar, is characterized by less elasticity than healthy tissue and can over time, because of the anatomical location, cause significant limitations of the active range of motion (arom) of the scapulohumeral joint. after this procedure it's possible that axillary web syndrome (aws) occurs. this study discusses the physiotherapy management of patients with aws. the primary objective of the study was to verify direct and indirect changes to aws cords with two treatment methods at a single breast cancer rehabilitation setting: physiotherapist 's work vs. self-treatment.

breast cancer is the most common form of cancer among women. axillary surgical procedures have reported, with post-operative morbidity of bleeding, lymphedema and shoulder pain, also the rather underestimated axillary web syndrome. the study shows that the reduction of the problems linked to the syndrome such as pain in shoulder abduction and flexion and inability in everyday life is possible with an early and competent treatment. two different approaches to the syndrome were investigated. the patients were divided in two groups. good results were obtained within 5 weeks since the appearance of aws with both of them but if the physiotherapist is able to teach the convenient exercises, the selftreatment seemed to have the best outcome. this fact can change the awareness that an early approach is necessary inside the path to recovery. in the last years the axillary web syndrome was the topic of many studies: the etiology, its clinical diagnosis, the relation with lymphedema...but the treatment was often reported like a combination of different techniques without indications about kinds, times. instead the investigators examined a detailed procedure, the same in both groups. the work was different only as regards the cords treatment. this fact shows the value of a comprehensive treatment for neck, shoulder, breast and two different but specific works on the axillary web syndrome. for these reasons its publishing could be important for all the professionals working with women after surgery for breast cancer and metastatic lymphnodes.

Eligibility criteria:
inclusion criteria: 1. age \> 18years; 2. patients able to sign informed consent; 3. patients who underwent alnd surgery for breast cancer; 4. presence of cords associated with a.w.s.; 5. surgeon examination carried no more than 10 days after the operation. exclusion criteria: 1. presence of cords after ad due to melanoma metastasis.

Keywords: axillary web syndrome
intestinal microbiota composition after antibiotic treatment in early life

Conditions: Microbiota; Eczema; Atopy

Summary: in this prospective observational cohort study the potential clinical consequences of antibiotic use in early life and perturbations in the gastrointestinal microbiota composition due to that antibiotic use are studied. it is hypothesized that altered microbiota may be an important underlying mechanism for impediments in the developing immune system. differentiation will be made between a group of neonates who received antibiotics in the first week of life, and control infants who were not exposed to antibiotics in the neonatal period.

healthy newborns born in the hospital, observed for low probability of neonatal infection will be compared to newborns exposed to antibiotic therapy in early life (first 1-2 weeks). infants are recruited from the maternity wards and neonatal wards of four teaching hospitals in the netherlands. in total 150 infants, treated with antibiotics because of (a high suspicion of) a perinatal infection during the first week of life, will be recruited. the control group comprises 300 healthy newborns, born in the hospital and needing clinical observation for 24-48 hours for several reasons like maternal comorbidity, low probability of neonatal infection, blood sugar monitoring, meconium containing amniotic fluid, or delivery by caesarean section. differences in clinical outcomes between antibiotic treated infants and controls are investigated. incidence of atopic dermatitis (eczema), food allergy, upper respiratory tract infections (urti), lower respiratory tract infections (lrti), gastrointestinal infections (giti) and excessive crying are evaluated, prospectively assessed by parental reports and retrospectively assessed by doctor's diagnoses. the clinical endpoints will be linked to the developing intestinal microbiota during the first year of life. potential differences in intestinal fecal microbiota composition and diversity can be determined at eight time points during the first year of life, as sampling moments include: day one (t1), day two (t2), one week (t3), two weeks (t4), one month (t5), three months (t6), six months (t7), one year (t8).

Eligibility criteria:
inclusion criteria: 1. term-born babies (≥ 36 weeks gestational age) 2. (short) stay on maternal ward or admission to neonatal ward because of antibiotic treatment 3. signed informed consent by the parents exclusion criteria: 1. congenital illness or malformations 2. severe perinatal infections for which transfer to the neonatal intensive care unit is needed 3. maternal probiotic use ≤ six weeks before delivery 4. insufficient knowledge of the dutch language.

Keywords: intestinal microbiota antibiotics infant allergy
health status of patients after surgically implanted biological and tavi: a population-based retrospective analysis

Conditions: Aortic Valve Disease

Summary: the overall project aim is to study outcomes following aortic valve replacement with surgically implanted bioprostheses or tavi by retrieving data from the main social security carriers in austria for the years 2010-2020.


Eligibility criteria:
inclusion criteria: * isolated aortic valve replacement in austria (surgically implanted bioprostheses or tavi) exclusion criteria: * below 65 years of age * coronary revascularization within 4 months before the index procedure * concomitant heart surgery