Kornimate/medical-research-clean huggingface dataset:
the efficacy of prophylactic antibiotic administration during breast cancer surgery in overweight patients.

Conditions: Breast Cancer

Summary: this is a single center trial to compare the rate of surgical site infection (ssi) in normal (bmi equal to or less than 25; control group)) and overweight (bmi over 25) women who are undergoing breast cancer surgery. the overweight patients are further randomized into two groups; in one group patients receive prophylactic antibiotics (ampicillin/sulbactam; prophylaxis group), in the other they do not (no prophylaxis group).

context although breast surgery is regarded as clean surgery, the actual ssi rate is well above accepted range in various series. retrospective studies showed bmi as one of the factors which may have caused increased ssi rate after breast cancer surgery. yet, no prospective randomized study assessed the efficacy of chemoprophylaxis during breast surgery in overweight patients. objective to compare the ssi rate between three groups of early stage breast cancer patients in which two are assigned according to randomization. first, patients are grouped into two according to their bmi. all patients (control group) with bmi equal to or below 25 do not receive any antibiotics as prophylaxis. patients with a bmi above 25 are randomly assigned to receive a single dose prophylactic ampicillin /sulbactam combination before surgery (prophylaxis group) or not to receive chemoprophylaxis (no prophylaxis group). design, setting and patients patient recruitment is still continuing after the study started in october 2003 in order to reach a sample size of 360 patients with bmi over 25. advanced or distant metastatic stage, receiving neoadjuvant therapy, history of receiving antibiotics within prior 3 months, history of immunodeficiency, having a remote infection and history of reaction to treatment antibiotics are within the exclusion criteria. interventions all patients are followed for 30 days postoperatively (once in a week at the original surgical unit). patients and the investigator who inspects all wounds are blinded. cost of ssi-related prophylaxis and treatments (including additional hospital visits after discharge, physician charges, additional antibiotics, wound management, other drugs and interventions etc) is calculated in each study group and compared with each other.

Eligibility criteria:
inclusion criteria: * women at any age with early stage breast cancer (stage i-ii) and american society of anesthesiologists (asa) score of i-ii. exclusion criteria: * ductal carcinoma in situ (dcis; stage 0 cancer), * advanced or distant metastatic stage, * receiving any neoadjuvant therapy, * history of receiving any antibiotics within prior 3 months, * history of immunodeficiency, * having a remote infection, * history of reaction to study antibiotics, * denial of signing the consent form.

Keywords: breast cancer breast surgery clean wound overweight prophylaxis antibiotics
pilot study of a web-based decision aid for young women with breast cancer, during the proposal for preservation of fertility

Conditions: Breast Cancer

Summary: comparative study of two information modalities during the care course, aiming to propose the preservation of fertility to young women with breast cancer (but not yet under treatment): standard oral information during the pf consultation vs. an online decision support tool, consulted prior to the pf consultation, during which the standard oral information is provided.

in recent decades, the incidence of breast cancer has increased significantly among young women. between 1980 and 2012, there was an increase of 59% and 53% in the 30-39 age group and the 40-49 age group, respectively. however, both diagnostic and therapeutic advances made it possible to significantly reduce mortality, at the cost of potentially deleterious chemotherapeutic treatments for reproductive function. these treatments may therefore be the cause of a chronic pathology "infertility" that may negatively impact the quality of life of young breast cancer survivors. since 2004, in france, the preservation of fertility (pf) is part of the different laws of bioethics. the latest cancer plans have highlighted the importance of quality of life in patients cured of cancer. for young women, this often involves the possibility of accessing maternity, using their own gametes. thus, access to an onco fertility consultation should be systematically proposed, ideally before the initiation of any cancer treatment. while the importance of oncofertility consultations is now recognized, they raise a certain number of ethical questions, particularly as to the nature of the information to be transmitted, whether it is generalizable or not, and how it is delivered and supported. very little data on the value of decision support tools in pf for women with breast cancer are available, while the concept of "shared medical decision" is becoming increasingly important in the doctor-patient relationship. the only available studies have shown that these tools can reduce the level of decisional conflict and regret over fertility-related treatment options, and improve knowledge about fertility and satisfaction among young women. this study aims to compare two modalities of delivery of information to breast cancer patients (not yet under treatment): standard oral information during the prevention of fertility (pf) consultation vs. an online decision support tool, consulted prior to the pf consultation, during which the standard oral information is provided.

Eligibility criteria:
inclusion criteria: * 18-40 years women * with breast cancer * cancer treatment not started, no antecedent of chemotherapy * speaking french * affiliated in social insurance exclusion criteria: * recurrence of breast cancer * metastatic breast cancer * pregnancy in progress * adults protected (wardship, guardianship, protection of justice)

Keywords: breast cancer preservation of fertility online support decision tool
inflammation, intracellular invasion and colonization of the nasal mucosa by staphylococcus aureus

Conditions: Healthy

Summary: an inflammatory state of the nasal cells (very close to keratinocytes) could favour the internalization of staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium. staphylococcus aureus is a commensal bacterium of the skin and mucous membranes that colonizes approximately 2 billion people worldwide staphylococcus aureus is also a leading cause of community and healthcare-associated infection. staphylococcus aureus has demonstrated its ability to invade many non-professional phagocytic cell lines such as keratinocytes, osteoblasts, fibroblasts, epithelial cells and endothelial cells. during pro-inflammatory stimulation, internalization of staphylococcus aureus into keratinocytes is mainly mediated by icam-1. these results suggest that, in humans, an inflammatory state of the nasal cells (very close to keratinocytes) could promote the internalization of staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.

the main objective is to compare the expression level of icam-1 in nasal cells with and without the presence of staphylococcus aureus.

Eligibility criteria:
inclusion criteria: * subject affiliated to a social security scheme or entitled person * subject who received informed information about the study et signed consent * adult subject (≥18ans) * healthy volunteer exclusion criteria: * subject undergoing antibiotic treatment or having received antibiotic treatment (oral, iv or local) in the month prior to inclusion * subject with a major haemostasis disorder or anticoagulant treatment contraindicated for surgery * subject with a pathology increasing the nasal carriage of s. aureus (chronic furunculosis, diabetes, hiv infection, chronic rhinosinusitis) * subject under guardianship or trusteeship * pregnant woman

Keywords: staphylococcus aureus icam-1 nasal cells s. aureus nasal swab
phase 3 randomized study of telcyta + doxorubicin versus doxorubicin in platinum refractory or resistant ovarian cancer

Conditions: Ovarian Neoplasms

Summary: the purpose of this research study is to determine if telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.

this is a randomized, open label, multicenter, multinational phase 3 study of tlk286 (telcyta) in combination with liposomal doxorubicin (doxil/caelyx) as compared to the active control therapy with liposomal doxorubicin (doxil/caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. patients will be randomly assigned to receive either tlk286 (telcyta) in combination with liposomal doxorubicin (doxil/caelyx) or active control liposomal doxorubicin (doxil/caelyx).

Eligibility criteria:
inclusion criteria: * are a woman 18 years of age or older * have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer * have platinum refractory or resistant cancer * measurable disease according to radiographic recist criteria progression exclusion criteria: * had treatment with first-line chemotherapy other than a platinum-containing regimen * have clinically significant cardiac disease * have any sign of intestinal obstruction interfering with nutrition * are pregnant or lactating * had prior treatment with liposomal doxorubicin * had prior treatment with telcyta

Keywords: ovary
the efficiency of periarticular multimodal drug injection in pain management following primary unilateral tka

Conditions: Arthritis Knee; Pain; Arthroplasty Complications

Summary: this interventional study aims to compare the effectiveness of local multimodal drug periarticular injection in tka patients with the standard pain control regime that includes opioids, nsaids, and other analgesics. the main questions the investigators strive to answer are: is there a significant difference in the severity of pain and functional outcomes when applying periarticular injections? are there any increased complications when applying the periarticular injections?

the best pain control regime following tka is controversial. while opioids have an excellent analgesic effect, they also have many side effects. the investigators are conducting a randomized controlled trial to compare the severity of pain following primary unilateral tka when multimodal drug periarticular injunction is used with the standard pain control regime. the investigators will enroll patients undergoing primary unilateral tka and randomly allocate them into one treatment group. the first will undergo the procedure with periarticular injection before the closure is composed of a mixture of 20ml of low body weight bupivacaine 5mg/ml plus 1ml of ketorolac 30mg/ml plus 0.5ml adrenaline 1mg/ml injected in medial and lateral retinaculum, medial and lateral collateral ligaments, quadriceps and patellar tendon, joint capsule, subcutaneous fat, and the second will go standard tka with pain control using opioids, nsaids, and paracetamol. the severity of postoperative pain is the primary outcome studied, as well as preoperative complications and any drug side effects, the data will be collected by a fellow researcher who is blinded to the interventions, and the patients will be blinded too. randomization will be done by a research fellow who is not involved in patient treatment or care.

Eligibility criteria:
inclusion criteria: * all patients with end-stage arthritis of the knee going primary unilateral total knee arthroplasty. exclusion criteria: * inflammatory and secondary arthritis of the knee. * patients who are allergic to one or more of the drugs used in the injections. * patients who are already taking opioids for whatever reason or have a history of addiction. * bmi less than 20 and more than 35. * patients with intra-operative complications that would affect the outcomes measurement. * patients who are going through complex primary or revision tka. * pregnancy, renal or liver failure. * patients who are classified as grade 3 or more according to asa.

Keywords: total knee arthroplasty arthritis pain injection
a single dose study of oral vadadustat in subjects with normal and impaired hepatic function

Conditions: Hepatic Impairment

Summary: this is a phase i open-label study to evaluate the pharmacokinetic (pk) profile of a single oral dose of vadadustat in subjects with hepatic impairment(hi) compared to healthy matched control subjects with normal hepatic function.

this is an open label, parallel-group, single dose, phase 1 study to evaluate the pk profile, safety, and tolerability of a single oral 450 mg dose of vadadustat in subjects with hepatic impairment relative to control subjects with normal hepatic function. the study will enroll up to 24 subjects in 3 groups of 8 subjects at 2 study sites. blood samples for vadadustat pk and its metabolites will be collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, and 72 hours post-dose.

Eligibility criteria:
inclusion criteria (all groups): * male or female subjects between ≥18 years and ≤70 years of age * have a body weight ≥45 kg and body mass index (bmi) ≥18.5 kg/m2 to 40.0 kg/m2 additional group-specific inclusion criteria: * group 1 (moderate hepatic impairment subjects): * presence of moderate hepatic impairment (child-pugh class b) * group 2 (normal hepatic function subjects): * normal hepatic function * group 3 (mild hepatic impairment subjects): * presence of mild hepatic impairment ( child-pugh class a) exclusion criteria (all groups): * renal impairment ≥ stage 3 (estimated glomerular filtration rate \[egfr\] \<60 ml/min/1.73m2 using the modification of diet in renal disease (mdrd) study equation) * any history of active malignancy within 2 years prior to or during screening, except for treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin, or cervical carcinoma in situ; any history of tuberculosis and/or prophylaxis for tuberculosis * positive test for human immunodeficiency virus (hiv) antibody at screening. * hepatic or other organ or cell transplant * subjects with alcoholic cirrhosis must be sober for a minimum of 6 months

Keywords: hepatic impairment healthy subjects child-pugh vadadustat
diabetes mellitus and inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: diabetes mellitus is a hyperglycemic metabolic disorder due to insulin deficiency or resistance at its receptors, leads to impaired glucose metabolism and multi-organ affection; (optic, peripheral neurological, cardiovascular and renal).

inflammatory bowel disease; (crohn's disease and ulcerative colitis), is chronic relapsing inflammation in the gastrointestinal tract due to complex interactions among genetic, environmental, gut microbiome, and immunologic factors. inflammatory bowel disease treatment inhibits the abnormal inflammatory response to heal intestinal tissue, relieve the abdominal pain, the diarrhea and the fresh bleeding per rectum, also decreases the frequency of flare-ups and maintains remission. amino-salicylates and antibiotics are step i drugs act on the intestinal lining and on presented inflammatory masses. corticosteroids are step ii drugs on failure of step i drugs for adequate control of the inflammatory bowel disease and rapid relief of symptoms and inflammation. the immune modifying agents as azathioprine and 6 mercaptopurine are step iii drugs on failure of the steroids. biologic agents are anti tumor necrotic factor agents (infliximab and adalimumab) and non anti tumor necrotic factor agents (vedolizumab, ustekinumab and natalizumab). inflammatory bowel disease may have endocrinal and metabolic associations in the form of; lipid abnormalities and insulin resistance. also, insulin resistance and hyperglycemia may be due to steroid use as steroid upgrades (hepatic gluconeogenesis, inhibition of glucose uptake in adipose tissue, and impairment of insulin action). there is no epidemiological evidence that inflammatory bowel disease is a definite risk factor for diabetes. in this study, the association of diabetes in patients with inflammatory bowel disease will be determined.

Eligibility criteria:
inclusion criteria: - all patients with ibd admitted at el-raghy assiut university hospital in the period of first of october 2019 to the end of september 2020 the diagnosis of dm is confirmed by high random blood glucose level more than 200mg/dl three times per day or high hba1c more than 6.5%. the diagnosis of ibd is confirmed by colonic biopsy results after colonoscopy. exclusion criteria: * patients didn't do colonoscopy or didn't get biopsy or with normal colonoscopy and biopsy
evaluating lung doppler signals in patients with systemic sclerosis (ssc)

Conditions: Systemic Sclerosis; Pulmonary Hypertension

Summary: doppler signals can be recorded from the lung parenchyma by means of a pulsed doppler ultrasound system incorporating a special signal processing package; i.e. the transthoracic parametric doppler (tpd) (echosense ltd., haifa, israel). systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. the tpd system may provide important insight into pulmonary blood vessels characteristics by the lds signals that are related to pulmonary hypertension. the tpd performance in detecting pah in ssc patients will be assessed in the study.


Eligibility criteria:
inclusion criteria: 1. able and willing to give signed informed consent prior to enrollment 2. male or female, ≥ 18 years of age 3. diagnosis of ssc according to 2013 acr/eular ssc classification criteria (van den hoogen 2013): score ≥ 9. 4. patients with rhc data available from measurement within 3 weeks prior to tpd assessment 5. no change in or initiation of pah specific therapy between the last rhc and tpd exclusion criteria: 1. people unable or unwilling to give informed consent. 2. pcwp or lvedp \> 15 mmhg 3. any ph etiology outside group 1 (dana point, 2008) 4. pregnant women 5. patients having severe chest wall deformity

Keywords: systemic sclerosis pulmonary hypertension lung doppler signals
inhibitory control and pediatric weight management

Conditions: Overweight and Obesity

Summary: the purpose of this pilot study is to explore the benefits of supplementing the kurbo online program with a cognitive training game (polyrules!) among youth ages 7-13 with overweight or obesity.


Eligibility criteria:
inclusion criteria: * between 7-13 years old at time of enrollment * are able to read, write and speak english * bmi%ile ≥ 85%ile exclusion criteria: * concurrently enrolled in another weight loss intervention, are currently taking anti-obesity medications, or are undergoing bariatric surgery * have type 1 or type 2 diabetes * have severe cognitive delays * have visual/hearing impairments
association between obstructive sleep apnea and bruxism

Conditions: Bruxism, Sleep; Obstructive Sleep Apnea

Summary: the objective of this retrospective observational study will be to investigate the between the obstructive sleep apnea syndrome (osas) and sleep bruxism (sb), in individuals diagnosed through polysomnography (psg).

the sb and osas are sleep disorders with great importance for dentistry. the osas is characterized by partial or total obstruction of the upper airways. sb is defined as a repetitive activity of the mandibular musculature characterized by the tightening or grinding of the teeth and/or by the retrusion or propulsion of the mandible. this study retrospective observational will be evaluation to investigate the association between osas and sb. data from psg and medical records (n=640) will be collected from january 2012 to july 2018 at "instituto do sono de pelotas (isp)".

Eligibility criteria:
inclusion criteria: * adults (aged 20 to 60 years) and elderly (aged \> 60 years) (who-world health organization, 2015) who was undergone psg at the "instituto do sono de pelotas (isp)"; * have completed all the respective psg reports. exclusion criteria: •those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of psg.

Keywords: sleep bruxism polisomnography
aneurysmal bone cyst imaging after interventional radiology treatment

Conditions: Bone Cysts

Summary: this study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization)


Eligibility criteria:
inclusion criteria: * male of female * aging from 0 to 30 years * with typical aneurysmal bone cyst at initial imaging * at least one interventional radiology procedure performed exclusion criteria: * no initial surgery * patient refuses to participate

Keywords: radiology, interventional epidemiology vascualr embolisation percutaneous alcoholization aneurysmal bone cyst
cervical stabilization exercises in patients with spondyloarthritis

Conditions: Spondyloarthritis

Summary: the aim of this study is to investigate the effectiveness of cervical stabilization exercises on cervical positioning error in spondyloarthritis patients.

the position sense and kinesthesia are defined as proprioception. in other words, proprioception allows being aware of positions of the body parts in the space. muscles, tendons, joint capsules are source of proprioception. possible damage to these structures due to inflammation may cause diminished proprioception sense. decreased proprioception was shown for cervical region in axial spondyloarthritis patients in a recent study. different exercise programs may help increasing proprioception. therefore, the aim of the present study is investigate the effects of cervical stabilization exercises on cervical proprioception accuracy.

Eligibility criteria:
inclusion criteria: * being diagnosed as axial spondyloarthritis according to asas criteria * being able to understand and follow the exercise commands * willingness to participate in the study exclusion criteria: * trauma history related to cervical region * a completed ankylosis in cervical region * surgery history related to cervical region * any vestibular disorders * upper extremity involvement other than axial spondyloarthritis

Keywords: arthritis exercise proprioception