Kornimate/medical-research-clean huggingface dataset:
omission of slnb in cn0 early breast cancer

Conditions: Breast Cancer; Clinically Assessed Negative Axillary Lymph Nodes; Sentinel Lymph Node

Summary: the omslnb trial adopts a prospective, single-arm, non-inferiority, phase-ii, open-label study design. patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cn0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including mri, pet-ct, \[18f\]-fdg pet-mri, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (bcs). so as to decrease the edema of upper arm, and finally improve the quality of life of the patients.


Eligibility criteria:
inclusion criteria: 1. female patients aged 18-70 years; 2. pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery; 3. negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast mri, breast pet-ct, breast pet-mri, breast pet); 4. all patients are required to undergo immunohistochemical staining for estrogen receptor (er), progesterone receptor (pr), human epidermal growth factor receptor 2 (her2), ki-67 proliferation index, and further fluorescence in situ hybridization (fish) should be performed in her2 2+ cases; 5. good compliance, normal comprehension and ability to receive treatment and follow-up as required; 6. ecog score 0-1; 7. patients volunteered for this study and signed the informed consent form. exclusion criteria: 1. bilateral/lactating/pregnant breast cancer; 2. previous history of malignant tumor or neoplasm; 3. clinical or imaging confirmation of distant metastasis; 4. history of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity; 5. prior history of radiotherapy to the breast or chest; 6. positive pathological margins after breast-conserving surgery or mastectomy; 7. severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection; 8. aspartate aminortransferse (ast) and alanine aminotransferase (alt) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; left ventricular injection fraction (lvef) \< 50% on cardiac ultrasound; 9. inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons; 10. no personal freedom and independent civil capacity; 11. presence of mental disorders, addictions, etc; 12. not eligible for enrollmentas as judged by the investigator.

Keywords: breast cancer clinically assessed negative axillary lymph nodes sentinel lymph node biopsy
perioperative eras based nursing intervention for laryngeal cancer patients

Conditions: Laryngeal Cancer; Nursing

Summary: to explore the effect of perioperative eras based nursing model on the hope level and recovery of patients with laryngeal cancer.

200 patients who were diagnosed with laryngeal cancer and received total or partial laryngectomy were included. they were allocated into experimental and control group. patients in experimental group were given eras based nursing intervention. control group were given routine nursing intervention. compare hope level, postoperative recovery, complication between two groups.

Eligibility criteria:
inclusion criteria: * patients were confirmed as laryngeal cancer by ct scan. * patients were given total or partial laryngectomy. exclusion criteria: * unconscious or psychiatric patients. * patients with distant metastasis or recurrence of cancer * patients with coagulation dysfunction * patients with severe cardiac, hepatic or renal dysfunction.

Keywords: laryngeal cancer enhanced recovery after surgery hope level
muscle soreness and stiffness in patients with chronic or frequent episodic tension type headache.

Conditions: Tension-type Headache

Summary: the aim is to investigate muscle soreness and stiffness in patients with chronic or frequent episodic tension type headache before and after treatment with amitriptyline - and to compare the results with healthy individuals.

the muscle stiffness is measured with ultrasonic shear wave elastography in m. masseter, m. sternocleidomastoid and m. trapezius. the muscle soreness is measured by palpation of the muscles aided by a so called palpometer.

Eligibility criteria:
inclusion criteria: * chronic tension type headache or frequent episodic tension type headache with at least ten episodes or more per month throughout three months or more. * pericranial muscle tenderness exclusion criteria: * other primary headache disorder (with the exception of episodic migraine.) * pregnancy or ongoing breastfeeding * heart disease that contradicts treatment with amitriptyline * drug or substance abuse
splinting versus not splinting of the distal lower extremity after intramedullary nailing for tibial fractures

Conditions: Tibia Fracture

Summary: two standards of care exist with regards to posterior splinting post-operatively. the proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (rom). the opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. with regards to both practices, the surgeon's practice is anecdotally based on past experience. the purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (im) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice.


Eligibility criteria:
inclusion criteria: * isolated tibia fracture that is open grade ii or less and all closed tibia fractures that are amenable to treatment with an im nail exclusion criteria: * pregnant women * prisoners
effect on bacterial glycolytic acid formation on plaque

Conditions: Dental Plaque

Summary: to determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.


Eligibility criteria:
inclusion criteria: * maxillary dentition is preferentially natural. * maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition. * natural mandibular front teeth and first premolars (4-4) are retained. * second mandibular molars are ideally present to serve as abutment teeth. * mandibular restorations and/or reconstructions must be in clinically good condition. * partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition. * subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax). * willingness to give their informed consent and comply with the protocol. * no history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study exclusion criteria: * current participation in other dental clinical trials. * subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment). * subjects in whom the plaque ph fails to fall sufficiently, i.e. at least to ph 5 following a sucrose rinse. * subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases. * subjects taking drugs known to currently affect salivary flow. * subjects with un-stimulated salivary flow \<0.3 ml/min and/or stimulated flow \<0.9 ml/min. * women who are pregnant or breastfeeding * history of allergy to common dentifrice ingredients * immune compromised individuals (hiv, aids, immuno suppressive drug therapy) * women of child bearing potential and not on birth control (diaphragm, birth control pills or implants, iud (intrauterine device) or condoms) * medical condition which requires premedication prior to dental procedures/visits * history of allergy to amino acids
trigger points of supraspinatus muscle: osteopaths' palpation reproductibility and ultrasound translation

Conditions: Shoulder Pain

Summary: trigger points (tp) are described as "hard, palpable nodules located within the taut bands of skeletal muscle" (bardoni, 2022). the aim of this study is to evaluate the reproductibility of palpation of tp between osteopaths and to compare this perception to ultrasound measures of echogenicity. method: a sample of 61 patients will be included in the study. an osteopath will determine the eligibility of the study. the supraclavicular area will be mark every 2 cm to establish a grid for all evaluations. first an osteopath will evaluate with palpation the presence of tp at every box of the grid. a second osteopath will evaluate the same boxes and will be blinded to the result of the first osteopath. at each step of palpation, a pain assessment will be carried out at each box. then, the ultrasound technician will evaluate the echogeneicity of every box and will be blinded to the prior results. the protocol will be approve by a french ethic committee.

sensitivity and specificity of osteopathic tests will be conducted in comparaison to echograph results (a binary outcomes assessing the presence of an hypoechogenicity). the reproductibility of osteopaths' tests will be be calculated using cohen's kappa weighted by the distance between the tps found. finally, the pain reported by patients on areas with a tp defined by the osteopath, and the pain reported by patients on areas without a tp defined by the osteopath will be compared using a student test.

Eligibility criteria:
inclusion criteria: * adults (18 to 50 years old), * affiliation to a social security scheme or beneficiary of such a scheme exclusion criteria: * pregnant and breastfeeding women, * adults under guardianship and protected patients. * history of integumentary or muscular involvement in the area of interest * allergic reaction * wish to stop the study

Keywords: trigger point osteopathic palpation ultrasound
pharmacokinetics of a single 14c-labeled dose of risedronate or alendronate followed by once-a-week unlabeled oral dose

Conditions: Osteopenia; Osteoporosis

Summary: the primary objective of this study is to compare the urinary excretion of 14c-labeled risedronate and alendronate over 28 days.


Eligibility criteria:
inclusion criteria: * have medical history documentation verifying postmenopausal status of at least 2 years (natural or surgical). if not documented, confirmation will be required using estradiol \ 40 iu/ml; * have osteopenia or osteoporosis (\< 1.002 g/cm2 lunar or \< 0.882 g/cm2 hologic) as determined by dxa of the lumbar spine (ap or pa view, l1-l4). this corresponds to a t-score of approximately \< -1.5. exclusion criteria: * any clinically significant out-of-range laboratory values and vital signs, * a clinically significant cardiovascular, hepatic, renal, or parathyroid disease, in the opinion of the investigator * a known hypersensitivity to bisphosphonates
comparing hilt, steroid injection, and manual therapy for frozen shoulder

Conditions: Frozen Shoulder

Summary: this study compares three common treatments for frozen shoulder when added to a standard exercise program: high-intensity laser therapy (hilt), a corticosteroid (steroid) injection into the shoulder joint, and hands-on manual therapy by a physical therapist. a fourth group will receive only the standard exercise program. the goal is to see which combination works best to reduce shoulder pain and improve shoulder function over 6 months. the main outcomes are changes in pain (vas scale) and shoulder disability (spadi questionnaire) at 12 weeks.


Eligibility criteria:
inclusion criteria: age between 40 and 70 years, inclusive. clinical diagnosis of primary (idiopathic) frozen shoulder, defined by shoulder pain and ≥50% restriction in passive external rotation compared to the contralateral (unaffected) shoulder. symptom duration between 3 and 9 months. average shoulder pain intensity ≥ 4 on a 10-cm visual analogue scale (vas) over the past week. normal or age-appropriate radiographic findings of the glenohumeral joint (ruling out significant arthritis, fractures, calcific tendinitis). willingness and ability to attend scheduled treatment/assessment sessions. ability to understand study procedures and provide written informed consent. exclusion criteria: secondary frozen shoulder (e.g., post-traumatic, post-surgical, related to systemic disease like diabetes - clarify if diabetes is excluded or just secondary fs from diabetes). clinical or imaging evidence of significant rotator cuff tear requiring specific management. radiographic evidence of moderate to severe glenohumeral osteoarthritis (e.g., kellgren-lawrence grade ≥ 3). previous surgery on the index shoulder. significant neurological disorders affecting shoulder or upper extremity function (e.g., cervical radiculopathy, stroke). received a corticosteroid injection in the index shoulder within the past 3 months. known contraindications to corticosteroid injections (e.g., uncontrolled diabetes, allergy, local infection). known contraindications to high-intensity laser therapy (e.g., active malignancy in the treatment area, photosensitivity, pacemaker over treatment area). current participation in another interventional clinical trial for shoulder pain.
the correlation of reduction of levodopa and non-motor symptoms of parkinson's disease after deep brain stimulation

Conditions: Parkinson Disease; Visual Impairment

Summary: patients with parkinson disease (pd) usually reduced the dose the levodopa after received deep brain stimulation (dbs). however, studies seldomly mentioned about the influences on non-motors systems after the reduction. our study focused on the changes after dbs and attribute them to the levodopa variety.

we calculated that group sample sizes of 126 patients (63 in group 1; 63 in group 2) would provide 80% power to reject the null hypothesis of equal means when the mean difference is -5(10-15) with standard deviations of 10 for test group and 10 for control group at a two-sided alpha of 0.05. given an anticipated dropout rate of 20%, total sample size required is 158 (79 in reduction; 79 in non-reduction group). written informed consent was obtained from all participants. after the baseline measurement, we informed the eligible patients the assigned randomization group with sealed opaque envelopes marked with the inpatient numbers . within 12 months after stn-dbs, the ledd of the intervention group was consistent with that before operation, and gradually decreased under the guidance of physician according to the expert consensus of dbs after 12 months. the compliance problem was solved by determining the actual number of antiparkinsonian medications returned by participants.

Eligibility criteria:
inclusion criteria: * participants underwent neuro-ophthalmologic examinations, including ocular fundus photography, automated perimetry, and oct. patients undergoing deep brain stimulation (dbs) took an extra vipd-q after the operation. exclusion criteria: * secondary causes of parkinsonism, prior brain surgery (except dbs), glaucoma, intraocular surgery, diabetes and other diseases affecting the visual field or neurologic systems, and the current use of medications affecting visual function.

Keywords: deep brain stimulation levodopa
a study of imr-687 in healthy adult volunteers

Conditions: Sickle Cell Disease; Sickle-Cell; Hb-SC; Sickle Beta 0 Thalassemia

Summary: the purpose of this phase 1a, first in human, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, pk and pd profile of the orally administered imr-687 in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * be healthy as judged by the investigator on the basis of pre-study tests performed at screening, with healthy body mass index (bmi), healthy body weight, and laboratory results within normal laboratory reference range or determined not to be clinically significant by the investigator; and be free from drugs of abuse. exclusion criteria: * females who are pregnant, trying to become pregnant, or breastfeeding; and males with female partners who are trying to conceive. * asthmatics or other individuals who use or may use albuterol rescue inhalers or nebulizers. * a significant history of cardiovascular disease. * on ecg, a qtcf \>450 ms or the presence of clinically significant abnormalities as determined by the investigator. * elevated blood pressure. * use within 30 days prior to day 1 of any inhibitors or substrates of targets of imr-687.

Keywords: sickle cell disease sickle beta 0 thalassemia
endoscopic scissors cutting nasobiliary duct vs bilateral plastic stent

Conditions: Cholangiocarcinoma, Hilar; Biliary Stricture; Hilar Cholangiocarcinoma; Klatskin Tumor; Biliary Disease; Bile Duct Diseases; Bile Duct Stenosis

Summary: the purpose of this study is to explore the efficacy and safety of endoscopic scissors cutting nasobiliary ducts in the treatment of malignant hilar biliary tract stenosis

the early diagnosis of hilar bile duct stenosis is difficult, and when the patient is diagnosed, the opportunity for surgical radical resection is lost, resulting in a poor prognosis. effective palliative treatment can significantly improve their quality of life and survival time. the method of cutting nasobiliary ducts with endoscopic scissors has many advantages. firstly, there are multiple lateral foramen of the nasobiliary duct, which increases the drainage area. secondly, the nasobiliary duct can be retained in the secondary bile duct, which is difficult to achieve with a conventional stent. the use of nasobiliary ducts can also reduce the difficulty of converting from external drainage to internal drainage.

Eligibility criteria:
inclusion criteria: 1. patients over 18 years old and under 80 years old who were planned to carry out ercp for malignant hilar biliary duct stenosis 2. clinically and pathologically confirmed malignant hilar biliary duct stenosis 3. mrcp determines bismuth classification: ii-iv type 4. comply with research procedures and sign the informed consent form exclusion criteria: 1. the patient has multiple organ dysfunction and cannot tolerate endoscopic treatment 2. the patient has undergone biliary drainage (endoscopic, percutaneous, or surgical) 3. the patient is currently suffering from cholangitis 4. the patient is participating in other clinical trials 5. inability to provide informed consent

Keywords: endoscopic retrograde cholangiopancreatography nasobiliary duct stent endoscopic drainage
impact of exercise combined with inulin propionate ester on fat oxidation

Conditions: Exercise; Inulin Propionate Ester

Summary: there is evidence to suggest that responsiveness to exercise training programmes can be expected to be influenced by changes in resting fat oxidation, an important factor in the aetiology of obesity. our previous work has shown that oral supplementation with inulin propionate ester (ipe) reduces intra-abdominal fat and prevents weight gain and that oral propionate intake enhances resting fat oxidation. the effects of ipe combined with exercise training on resting fat oxidation and body fatness are unknown. the aim of this study was to investigate the impact of 4-weeks ipe supplementation, in combination with a moderate intensity exercise training programme, on whole body fat oxidation and on plasma glp-1 and pyy.

participants: healthy overweight females with bmi \>25 kg/m2 and 25-45 years of age were recruited through advertisements and word of mouth on the campus of the university of glasgow or from other public places. participants were required to be sedentary, non-smokers, with stable body weight for two months prior to the study enrollment, not pregnant, free of medication, nutritional supplementation or following any specific diet and with no antibiotic use for the past three months. participants with chronic illness, eating disorders and history of gastrointestinal operations were excluded. study design: this is a randomized study with a parallel design. study participants underwent 4 week supervised moderate intensity exercise training combined either with ipe (ex/ipe) or cellulose as placebo (ex/placebo) supplementation at doses of 10g / day. supplements were provided as sachets containing white powder and participants were asked to consume one sachet per day with breakfast in a way convenient for each participant. before the start of the study and at the end of the 4-week intervention, participants were asked to conduct a submaximal exercise test. prior to the first and after the second submaximal exercise test, participants of both groups conducted a 7-hour experimental trial which involved collection of expired air and blood samples in fasted and postprandial states. body weight and body composition were measured in the fasted state. prior to the first 7-hour experimental trial, participants were asked to record their diet for 3 days and replicate this intake prior to the second 7-hour experimental trial.

Eligibility criteria:
inclusion criteria: healthy, sedentary and overweight females with bmi \>25 kg/m2 and stable body weight for two months prior to the study. exclusion criteria: acute or chronic illness, eating disorders, history of gastrointestinal operations, smoking, pregnancy, taking supplements, and being on specific diet for the past three months.

Keywords: exercise, inulin propionate ester gut hormones body weigh fat oxidation overweight women
a long-term, extension study of e2020 in patients with dementia with lewy bodies

Conditions: Dementia With Lewy Bodies (DLB)

Summary: the purpose of this study is to evaluate the safety and efficacy of e2020 in patients with dementia with lewy bodies (dlb).


Eligibility criteria:
inclusion criteria: 1. patients diagnosed as probable dementia with lewy bodies (dlb) according to the diagnostic criteria for dlb. 2. patients who have completed phase ii double-blind study (e2020-j081-431). 3. patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution. exclusion criteria: 1. patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or who underwent brain surgery causing unsolved deficiency. 2. patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety. 3. pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion. 4. patients with severe extrapyramidal disorders (hoehn and yahr staging score is greater than iv). 5. patients whose systolic blood pressure is less than 90 mmhg or pulse rate is less than 50 beats/min.

Keywords: lewy body disease dementia clinical trial phase ii e2020 donepezil hydrochloride