Kornimate/medical-research-clean huggingface dataset:
strength training study for survivors of breast and gynecologic cancer

Conditions: Breast Cancer; Gynecologic Cancer; Ovarian Cancer; Uterine Cancer; Cervical Cancer

Summary: the purpose of this study is to compare once-a-week vs. twice-a-week strength training in survivors of breast and gynecologic cancer to determine which is the optimal exercise prescription.

as a result of cancer and its treatment, survivors of breast and gynecologic cancer are reported to have deficits in both physical and psycho-social health. in cancer survivors exercise has been shown to improve fitness, increase bone density and lean body mass, enhance self-esteem, and reduce fatigue. these changes have a positive effect on the survivor's physical functioning and quality of life. however, there are few studies which have examined the effects of strength training or studies aimed at determining optimal exercise prescription in this population. therefore, the purpose of this study is to compare two strength training prescriptions (once-a-week vs. twice-a-week strength training) to determine which prescription (if any) results in greater benefit for survivors. it is hoped that the results of this study will lead to a better understanding of how strength training improves the health of survivors and will help inform future exercise guidelines for this population.

Eligibility criteria:
inclusion criteria: * female survivor of breast or gynecologic cancer * completed primary treatment (hormone treatments are ok) * 18 years of age or older * physician's permission to participate exclusion criteria: * high risk individuals (determined by questionnaire) * secondary health problems that could increase the risk of participating (includes but not limited to: uncontrolled angina/hypertension, heart failure, osteoporosis, brain metastases, history of seizures). * report participating in a strength training program in the past six (6) months * have had a change in medication in the past 30 days

Keywords: cancer breast cancer gynecologic cancer strength training exercise physical activity fatigue quality of life strength fitness cancer survivor survivor
effect of dexmedetomidine on emergence agitation and postoperative behavior changes in children

Conditions: Emergence Agitation

Summary: emergence agitation (ea) is a dissociated state of consciousness in which the child is inconsolable, irritable, uncooperative, typically thrashing, crying, moaning, or incoherent. although usually transient, it is not only an extremely distressing event for children, parents, and staff, but may also result in self-injury or the need for restraint. the prevalence in children appears to be between 10% and 80% depending upon the definition and measurement tools used and is more frequently observed in the pre-school age-group. a clear correlation has been found between ea and negative postoperative behavioral changes, including anxiety, eating and sleeping disorders, enuresis, fear of darkness, that may persist for an extended period of time affecting emotional and cognitive development.currently, numerous interventions have been studied to manage ea after surgery. among them, dexmedetomidine (dex) as a kind of highly selective α2 adrenergic receptor agonist has been done to reduce ea in children. unfortunately, no studies examined posthospitalization negative behaviour changes.

the high incidence of ea and postoperative behavioural changes has encouraged paediatric anaesthetists and researchers to study methods to improve the perioperative care of children. dexmedetomidine is a selective alpha-2 receptor agonist with properties that make it attractive to pediatric use. it provides sedation and anxiolysis acting on these receptors in the locus ceruleus of the pons. it also exerts dose-dependent moderate primary analgesic effects through activation of alpha-2 adrenoreceptors in the dorsal spinal horn causing a subsequent decrease in substance p release. the study aims to explore whether a single low-dose dexmedetomidine in the perioperative period has a preventive effect on ea in children, and through short-term and long-term follow-up, to investigate the effect on post-hospitalization behavioural changes.

Eligibility criteria:
inclusion criteria: 1. age between 2-7 years old 2. american society of anesthesiologists（asa） score of i or ii 3. selective ear, nose, and throat surgery under general anaesthesia with sevoflurane exclusion criteria: 1. emergency surgery 2. were intubated before induction of anaesthesia or not planned for extubation after anaesthesia 3. had critical illness with haemodynamic instability, active bleeding, cancer, cardiac diseases including arrhythmias, malignant hyperthermia 4. intellectual disability, or neurological illness with agitation-like symptoms 5. weighed more than 50 kg 6. were allergic to dexmedetomidine 7. the use of sedative or analgesic medications before surgery
a trial comparing sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification. this is an extension to trial nn9068-3952, nct01952145 (dual™ v).


Eligibility criteria:
inclusion criteria: * completion (visit 28) of nn9068-3952 with insulin degludec/liraglutide + metformin * hba1c (glycosylated haemoglobin) above or equal to 7 percent at visit 27 of nn9068-3952 trial exclusion criteria: * clinically significant diseases of the major organ systems * screening calcitonin above or equal to 50 ng/l
the evaluation with artificial neural network of pain scales in children (ann)

Conditions: Pain

Summary: the study evaluates with artificial neural network (ann) of pain scales in children. pain of these patients' will be evaluated by many pain scales in the postoperative period.

pain of these patients' will be evaluated by many pain scales in the postoperative period. these scales include oucher, visiuel analog scale, flacc, faces pain scale revise, wong baker faces scale, faces pain scale, numeric rating scale, verbal rating scale, cheops and also age, blood pressure, respiratuar rate, heart rate will be recorded. in the first step of this study, the parameters taken into account on widely used each pain scale practically and importance level of each parameter will be examined. the parameters taken into account in determining the degree of pain and degree of each pain scale will be recorded. independent t-test of the pain scales will be analyzed whether different statistically. pain scales used in the application at conclusion statistical analysis will be grouped. in addition, parameters considered to be effective on pain (pulse, blood pressure, etc.) will be determined and also recorded. the degree of importance on pain of the current scales and other parameters to be determined and as result, new pain scale will be created. while determining the the level of importance will be utilized from the analytic hierarchy process (ahp). making binary comparisons between ahp and parameters, the level of importance and weightiness score of each parameter will be determined. the mathematical formulation of the pain points will be presented considering ahp weightiness score of each parameter. although pain scores obtained mathematically, pain score with artificial neural network (ann) will be estimated considering the parameters that impact on the pain score. the final step, the creation of new pain scale comparing the pain scores obtained by mathematical formulation and artificial neural network and, it is intended to be compared with the current scales.

Eligibility criteria:
inclusion criteria: * 2 months -18 years * children undergoing elective surgery exclusion criteria: * children with mental and motor development retardation * patients scheduled emergency surgery * patients and parents, who refused to participate in this study
adjunctive effect of acupuncture for advanced cancer patients with palliative care: a three-arm randomized trial

Conditions: Advanced Cancer

Summary: the proposed study aims to evaluate the adjunctive effect of ma with standard care (asc) for relieving cancer-related symptoms in a collaborative model of palliative care compared to sham ma plus standard care (ssc) or standard care alone (sc).

after being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. eligible participants will be randomized into three arms, asc, ssc, and sc, in a 2:1:1 ratio.

Eligibility criteria:
inclusion criteria: * all cases are subject to pathology and (or) cytology for a diagnosis of malignant tumour (pathological type is not restricted) at stage iiib or iv; * aged 18 years or above; * expected survival time longer than 16 weeks; exclusion criteria: * disseminated intravascular coagulation or severe thrombocytopenia with a bleeding tendency, i.e., low platelet count \ 1.5; hemoglobin ≤ 90 g/dl; white blood cell count ≤ 4x109/l; * uncontrolled active skin infection; * needle phobia; * inability to read and understand chinese; * not signed written informed consent. * receiving surgery during the whole study period; * receiving acupuncture treatment in the last 3 months

Keywords: advanced cancer palliative care acupuncture
cellular and molecular inflammatory mechanisms leading to bone resorption in peri-implantitis vs periodontitis

Conditions: Peri-Implantitis; Periodontitis

Summary: recent data found that peri-implantitis may differ from periodontitis at the histological level in terms of extent and composition of the cellular components. from human biopsies, it has been shown a deeper apical extension of the inflammatory cell infiltrate and a larger proportion of granulocytes and macrophages in peri-implantitis lesions compared to periodontitis lesions. following experimental peri-implantitis, it has been observed a continuing bone loss around dental implants after ligature removal; whereas, such a progression was not observed around teeth after cessation of the experimental periodontitis. the factors influencing the recruitment and the activation of osteoclasts in both diseases have not been compared yet. hypothesis : the more rapid and more severe alveolar bone destruction occurring in peri-implantitis compared to periodontitis is due at least in part to differences in the inflammatory process in these diseases. aim: to study the cytokine profile produced by gingival explants from periodontitis or peri-implantitis sites and to test the consequences on alteration of bone remodelling activity using in vitro approach. materials and methods the investigators will establish a collection of human gingival samples from patients undergoing surgical treatment of periodontitis or peri-implantitis. the investigators will test pro-inflammatory cytokines and chemokines release and consequences on osteoclast differentiation and activity.


Eligibility criteria:
inclusion criteria: * beneficiary by national health insurance * age: over 18 year-old * non smoking * good health ---for the periimplantitis group: * patients formerly treated with a non surgical procedure without antibiotics with at least one functional dental implant with at least on pocket deeper than 5 mm with bleeding on probing and radiographical alveolar bone loss. ---for the periodontitis group: * patients formerly treated with a non surgical procedure without antibiotics for a generalized severe chronic periodontitis (in accord to armitage 2009) and needing a resective surgical procedure (periodontal pockets deeper than 5 mm with bleeding on probing) ---for the healthy group: * patients with good health without periodontal or peri implant disease needing gingivectomy (crown lengthening, esthetic surgery) exclusion criteria: * smokers * patients treated with antibiotics or nsaid during the last 3 months * patients suffering from a chronic infectious, inflammatory or auto-immune disease (non equilibrated diabetes mellitus, rheumatoid arthritis, spondylarthrosis, gougerot-sjögren, crohn, behcet, horton, obesity, chronic end renal disease, cardiopathies....) * pregnant women * for the healthy group : bleeding on probing on the site.
highly aspherical lenslet (hal) and binocular vision (bv) disorders [halt x(t) study]

Conditions: Myopia; Strabismus

Summary: assess the effect and changes of eye misalignment (strabismus) with myopia control glasses assess the efficacy of myopia control glasses on childhood myopia progression in children with strabismus due to the uncertainty clinicians face when prescribing myopia control glasses to these strabismic children

studies have been done to show that spectacles, atropine eye drops, and outdoor activities have some efficacy in slowing myopia progression in children, however most of such studies exclude children with significant eye conditions such as strabismus or nystagmus to isolate the effects of myopia control treatment. in this study, we would like to investigate whether these specialized glasses can effectively slow down the progression of myopia in children with strabismus. since strabismus can affect visual development, this study would also be able to assess the effect and changes of eye misalignment (strabismus) with myopia control glasses. the study also aims to assess the efficacy of myopia control glasses on childhood myopia progression in children with strabismus due to the uncertainty clinicians face when prescribing myopia control glasses to these strabismic children.

Eligibility criteria:
inclusion criteria: age 5-12 years old myopia of between -1d and -6d in at least 1 eye progression of at least 0.5d within the last year astigmatism less than 2.5d exotropia exophoria: horizontal deviation \<40pd esotropia (good control), esophoria: horizontal deviation \<40pd any vertical strabismus: vertical deviation \<10 pd intermittent exotropia (good, moderate, poor) horizontal deviation ≥15 pd, vertical deviation ≤5 pd (?) exclusion criteria: va poorer than logmar 0.2 (6/9.5) in either eye any other ocular condition (e.g. lens opacity, glaucoma) other than myopia, strabismus or nystagmus) any medical/neurological condition which would interfere with subjects ability to co-operate with tests and attend follow-up appointments. plans of surgery for strabismus or nystagmus in the next year constant xt). past use of any other from of myopia control treatment (eg. atropine or myopia control glasses or contact lenses) within the last year.

Keywords: myopia strabismus halt stellest myopia control
the iguratimod effect on lupus nephritis (igelu)

Conditions: Lupus Nephritis

Summary: this study is a 52-week, randomized, open, active-controlled trial of patients with active diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic agent iguratimod. the subjects will randomly receive iguratimod or cyclophosphamide followed with azathioprine, both combined with steroids.


Eligibility criteria:
inclusion criteria: * active lupus nephritis: * fulfill acr classification criteria (2009) for sle * proteinuria ≥1g/24h at screening * nephritis of class iii, iv, v, iii+iv or iv+v, confirmed by renal pathology within 90 days prior to screening * body weight ≥40kg * sle-2k score ≥8 * agreement of contraception * informed consent obtained exclusion criteria: * active severe sle-driven renal disease or unstable renal disease at screening * active severe or unstable neuropsychiatric sle * clinically significant active infection including ongoing and chronic infections * history of receiving cyclophosphamide, azathioprine, tacrolimus , mycophenolate moetil or rituximab treatment with 90 days prior to screening * history of human immunodeficiency virus (hiv) * confirmed positive tests for hepatitis b or positive test for hepatitis c * active tuberculosis * live or attenuated vaccine within 4 weeks prior to screening * subjects with significant hematologic abnormalities * abnormal liver function test at screening (alt, ast or total bilirubin over 2 fold of upper normal level * history of peptic ulcer or gi bleeding; treatment with warfarin or other anticoagulants within last 14 days

Keywords: lupus nephritis iguratimod
clinical evaluation on the use of the x-pander device

Conditions: Osteoarthrosis; Total Hip Arthroplasty

Summary: the purpose of this study is to clinically evaluate the use of the x-pander device.

clinical evaluation on the use of the x-pander device during tha-surgery

Eligibility criteria:
inclusion criteria: * clinical diagnosis for hip osteoarthrosis exclusion criteria: * previous surgery of the actual hip

Keywords: total hip arthroplasty osteoarthritis
reduction of pro-inflammatory synovial fluid biomarkers in osteoarthritis of the knee with alpha-2 macroglobulin

Conditions: Osteoarthritis

Summary: the purpose of the current study is to assess the ability of alpha-2-macroglobulin treatment to reduce the level of pro-inflammatory synovial fluid biomarkers in patients with osteoarthritis of the knee. this is a double-blinded rationalized control trial with prospective data collection. the study will collect and analyze the synovial fluid, serum, and urine of patients presenting with knee osteoarthritis in kellegren-lawrence grade 2 or 3. it will compare synovial fluid biomarker levels between patients receiving an intra-articular alpha-macroglobulin, intra-articular pr injection and intra-articular corticosteroid serving as a control. pre-injection pain and function will be assessed. post-injection pain, function and outcomes will be assessed after six weeks and three months.


Eligibility criteria:
inclusion criteria: * patients osteoarthritis classified as kellegren-lawrence grade 2 or 3 exclusion criteria: * mentally impaired (e.g, alzheimer's subjects, dementia, etc.) * younger than 18 years of age * greater than 90 years of age * patients with underlying inflammatory arthropathies
a study of nivolumab plus ipilimumab in participants with renal cell cancer in the real world setting in japan

Conditions: Advanced or Metastatic Renal Cell Carcinoma

Summary: the purpose of the observational study is to evaluate the safety and effectiveness of combination therapy with nivolumab and ipilimumab in japanese participants with advanced or metastatic renal cell carcinoma (arcc) in the real-world setting in japan.


Eligibility criteria:
inclusion criteria: * histological confirmation of renal cell carcinoma (rcc) * no prior systemic therapy for rcc * participants who are planned to start treatment with nivolumab and ipilimumab regimen in the timeframe between after irb approval to enrollment-end date * international metastatic renal cell carcinoma database consortium (imdc) risk category intermediate/poor exclusion criteria: * participants who are enrolled in a post marketing safety study on nivolumab plus ipilimumab combination therapy in japan * pregnant and/or lactating women * participants who are judged to be inappropriate by investigator other protocol-defined inclusion/exclusion criteria apply.

Keywords: japanese observational study
cannabinoid vs opioid for photorefractive keratectomy pain control

Conditions: Photorefractive Keratectomy; Myopia; Hyperopia

Summary: photorefractive keratectomy (prk) is a commonly performed corneal refractive surgery but has significant post-operative pain. pain medications after prk are typically opioid-acetaminophen combinations. alternatives to opioid medication are worth consideration. patients will receive prk in each eye sequentially, using the cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.


Eligibility criteria:
inclusion criteria: * adults older than 18 years with refractive stability for 1 year electing to have prk surgery * consenting to participate * not meeting exclusion criteria will be included in the study population. exclusion criteria: * patients not candidates for prk will be excluded from the study. * patients taking other pain medications for concomitant medical conditions including, but not limited to tricyclic antidepressants, gabapentin and tramadol will be excluded from the study. * additional exclusion criteria will be known or suspected allergy or hypersensitivity to any of the routine or study medications. * patients completing follow up appointments at anywhere other than uf health ophthalmology clinic at the oaks will not be enrolled in the study. * patients who are pregnant or nursing are not eligible for prk, and such patients are not eligible to enroll in this study. female patients of child-bearing age will be pregnancy tested before surgery and study enrollment. * patients will be specifically counseled, and it will be noted in the written informed consent that use of the cannabinoid product may result in a positive thc urinalysis screening test so they may self-exclude if such a situation could cause social and/or employment conflict.
osteopathic manipulative treatment for gastro-oesophageal reflux disease

Conditions: Gastro-oesophageal Reflux Disease

Summary: to evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (gerd)


Eligibility criteria:
inclusion criteria: * retrosternal burning sensation and/or regurgitation * diagnosis of reflux with any methodology * duration of symptoms for more than 3 months * taking short or long-term proton pump inhibitors (as needed, treatment start date and expected end date, mg, drug name) * with or without esophagitis * with or without hiatal hernia * with or without helicobacter pylori * gerdq questionnaire \> 8 points exclusion criteria: * neoplastic pathologies * patients who have undergone surgery for gerd * systemic pathologies (rheumatic, infectious conditions, feverish state, vascular alterations, endocrine diseases including diabetes, metabolic and neoplastic syndromes), * patients already undergoing manipulative therapy for reflux * patients with active gastric ulcers * congenital or acquired immune diseases * allergic state of any kind * pregnancy * use of intrauterine device * patients undergoing corticosteroid therapy * patients already subjected to manual/respiratory therapy in the last 3 months

Keywords: gerd osteopathic manipulative treatment omt manual therapy
hippocampus avoidance pci vs pci

Conditions: Small Cell Lung Cancer; Lung Cancer

Summary: using intensity modulated radiotherapy it is possible to treat the entire brain to standard dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low. however, a clear relationship between radiation dose and damage to the hippocampal stem cells has not been established yet. this study is initiated to investigate the early and delayed neurotoxicity of pci and to assess in a randomised design the benefits and risks of sparing the hippocampus in small cell lung cancer patients who receive pci.


Eligibility criteria:
inclusion criteria: * - small cell lung cancer patients (stage i-iii or stage iv without clinical or radiological evidence of brain metastases) candidate for pci, i.e. without progressive disease after chemo-radiotherapy in stage i-iii or after a remission after chemotherapy in stage iv * sufficient proficiency in dutch exclusion criteria: * prior radiotherapy to the brain * clinical evidence for brain metastases or primary brain tumors- evidence of progressive extracranial metastatic disease * previous malignancy \< 2 years ago except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix * any systemic anticancer treatment during pci or within 3 weeks before start pci * pregnancy or lactation

Keywords: prophylactic cranial irradiation hippocampal avoidance prophylactic cranial irradiation