Kornimate/medical-research-clean huggingface dataset:
a post-market clinical study to evaluate the safety and performance of the carbon fibre reinforced polyetheretherketone metatarso-phalangeal (mtp) plate (colink® pcr mtp plate) for the treatment of hallux rigidus

Conditions: Hallux Rigidus

Summary: the clinical study involves the routine treatment of skeletally mature patients who have been diagnosed with hallux rigidus (stiffness of the first metatarso-phalangeal joint in the foot due to arthritis and degeneration of cartilage). it follows standard practice surgery to treat this condition. this type of degenerative arthritis affects the joint of the big toe (hallux) which is attached to the foot. taking part in this research will involve collecting data of the surgery to remove damaged cartilage and fix the two bones together with screws and a plate (called the colink® pcr mtp plate).


Eligibility criteria:
inclusion criteria: 1. subjects aged 18 years of age or older (\> 18 years) and are skeletally mature. 2. subjects who require surgical treatment for hallux rigidus and have been evaluated as appropriate candidates for treatment with the colink® pcr mtp plate by the investigator. 3. subjects who, in the opinion of the investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the hospital for all the required post-operative follow-ups. 4. subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained. exclusion criteria: 1. subjects who have previously undergone mtp fusion surgery or implant arthroplasty in the foot to be treated. 2. subjects who require bi-lateral mtp fusion surgery. 3. subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years. 4. subjects with a known allergy to the material used in the instrumentation. 5. subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study. 6. subjects who have any conditions outlined as contraindicated in the instructions for use. 7. female subjects who are pregnant or lactating. 8. subjects who are known drug or alcohol abusers, or with a baseline opioid use greater than 30 mg of morphine equivalent/day, or with psychological disorders that could affect follow-up care or treatment outcomes. 9. subjects who are current smokers or have stopped smoking less than 6 months ago. 10. subjects who are currently enrolled in a clinical study.
critical care ultrasound oriented shock treatment in icu

Conditions: Shock

Summary: objective to investigate whether critical care ultrasound oriented shock management in shock patients in intensive care unit(icu) can improve outcome. methods randomized controlled research. patients were randomly allocated to two groups. in the critical care ultrasound oriented shock management group (cuss group), treatment was oriented by the findings of critical care ultrasound in each shock phase, while in the control group the decisions about the monitoring and management were made by the clinical team. the goal of treatments in both groups were decreasing lactate by 20% or more per 2 hours for the optimization phase in shock management, and no increase lactate level when removing the fluid in de-escalation phase. the primary outcome measure were hospital mortality and 28-day mortality, the secondary outcome measure were the length of ventilation and the length of icu stay.


Eligibility criteria:
inclusion criteria: * sbp \ 40mmhg or need vasoactive drugs； * skin that is cold and clammy，capillary refill time \>4.5s，urine output of\ 2mmol/l； * shock presented within 6 hr. exclusion criteria: * \<18 years old； * pregnancy； * patient or family member refuse to be enrolled.

Keywords: shock critical care ultrasound lactate mortality prognosis
comparison of dietetics support with and without continuous glucose monitoring in individuals with type 2 diabetes.

Conditions: Type 2 Diabetes Mellitus (T2DM); Continuous Glucose Measurement; Dietary Modification

Summary: a parallel, single-blinded, randomised clinical trial conducted remotely across australia from the mary mackillop institute for health research (mmihr, australian catholic university) for individuals with type 2 diabetes, by researchers from australian catholic university, university of adelaide, university of queensland, university of wollongong, monash university, monash partners, deakin university, la trobe university and melbourne university.

in a parallel groups design, a total of 156 individuals will be recruited. after baseline pathology (hba1c), blinded (libre pro iq) continuous glucose monitoring (cgm) data and questionnaires (via redcap) have been collected, participants will be randomised into one of two groups (diet, dietetic support only; cgmd, cgm plus dietetic support). all participants will receive four (4) dietetic consults via telehealth at weeks 2, 6, 10 and 16, the content of which will be related to the randomised condition. measurements will be repeated at 3 and 6 months from baseline to assess the changes in primary and secondary outcomes.

Eligibility criteria:
inclusion criteria: * aged 18+ years * reside anywhere in australia and have a postal address * confirmed t2d diagnosis by a gp/endocrinologist * current hba1c of ≥7.0% * have a smartphone and able to independently use it exclusion criteria: * under the age of 18 years * use of insulin therapy (within the last three months) or medications which interfere with blood glucose levels (i.e. steroids) * use of cgm within the last six months * eating disorder examination questionnaire (ede-q) global score \>2.8 or global score \> or equal to 1.52, with sum of q14-18 \> or equal to 4 * currently having ongoing consultations with an apd or have had a consult with an apd (within last three months) * not weight stable (\>5 kg change over last three months) * severe hypoglycaemic event (i.e. requiring assistance) within last six months * change of antihyperglcyaemic medications within last three months * women who are pregnant or breastfeeding (within 24 weeks) * history of psychotic disorder, or current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder) * history of blood disorders (including but, not limited to, anemia and thalassemia) that impact the primary outcome (hba1c)

Keywords: continual glucose monitoring type 2 diabetes non-insulin dependant diabetes dietitian support health behaviours
phase ii pilot study of granulocyte colony-stimulating factor for inherited bone marrow failure syndromes

Conditions: Shwachman Syndrome; Fanconi's Anemia; Dyskeratosis Congenita; Thrombocytopenia

Summary: objectives: i. assess the efficacy of recombinant human granulocyte colony-stimulating factor (g-csf) in raising the absolute neutrophil count, platelet count, and hemoglobin level in patients with inherited bone marrow failure syndromes. ii. assess the efficacy of a reduced maintenance dose in patients who respond to daily g-csf. iii. assess the toxic effects of g-csf in these patients. iv. measure bone marrow progenitor colonies before and after g-csf. v. measure cd34-positive cells in marrow and blood before and after g-csf using flow cytometry and immunohistochemistry.

protocol outline: patients receive granulocyte colony-stimulating factor (g-csf) subcutaneously every day for 8 weeks; nonresponders receive an increased dose for an additional 8 weeks. patients who respond at week 8 or 16 are then tapered to a lower maintenance dose of g-csf administered every other day through week 40. the dose is adjusted to maintain an absolute neutrophil count above 1500. patients are removed from study for failure to achieve a complete response by week 16, unacceptable nonhematologic toxicity, the identification of a clonal karyotype in marrow, or the onset of leukemia.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- inherited bone marrow failure syndrome, including: * fanconi's anemia * dyskeratosis congenita * shwachman syndrome * amegakaryocytic thrombocytopenia * decreased megakaryocytes in infancy * no thrombocytopenia with absent radius syndrome (tar) * no trisomy 13 or 18 * no clonal bone marrow karyotype --prior/concurrent therapy-- * at least 4 weeks since growth factors * concurrent therapy allowed if not altered for 30 days prior to entry through week 8 * no concurrent investigational drugs --patient characteristics-- * hematopoietic: anc \<1000 * no leukemia * other: no medical or psychiatric contraindication to protocol participation * no pregnant or nursing women

Keywords: fanconi's anemia shwachman syndrome aplastic anemia dermatologic disorders dyskeratosis congenita hematologic disorders rare disease thrombocytopenia
improving food pleasure and intake of oncology patients receiving chemotherapy

Conditions: Colon Cancer; Breast Cancer; Chemotherapeutic Toxicity

Summary: the global cancer burden is estimated to have risen to 18.1 million new cases in 2018 (who), with a trend of ongoing growth. this very frequent illness exerts tremendous physical, emotional and financial strain on individuals, families, communities and health systems. malnutrition (under- or over-nutrition) is highly prevalent in cancer patients receiving chemotherapy and is an important predictor of morbidity, mortality, treatment response and toxicity. alterations in taste and smell are frequently reported as side effect of chemotherapy and may contribute strongly to malnutrition and to a worsen quality of life and wellbeing social, emotional, and role functioning. there are evidences that chemotherapy influences food liking and appetite with implications for food behaviours, including food enjoyment, food preference and dietary intake. a linkage between alterations in taste and /or smell and food behaviours has been reported by some studies but not all, suggesting that there is a need for more research using common standardised methodologies and larger sample size to gain a further insight into this topic.


Eligibility criteria:
inclusion criteria: * pathological diagnosis of colorectal or breast cacer * indication to adjuvant chemotherapy for colon cancer according local guide lines * indication to (neo)-adjuvant chemotherapy for reast cancer according local guide lines * possiility to sign an informed consent exclusion criteria: * patients aged \<18 years * patients aged \>80 years
precision medicine in ischemic stroke and atrial fibrillation

Conditions: Atrial Fibrillation; Ischemic Stroke

Summary: the overall goal of this study is to minimize morbidity due to atrial fibrillation (af). the specific objective is to develop and implement a rational and personalized approach to af risk estimation that can inform management decisions with ischemic stroke. the investigators propose to develop a clinical af risk estimation tool in the electronic health record and to test the effectiveness of implementing a clinical af risk estimation tool into care for use by stroke neurologists during the care of acute ischemic stroke patients at massachusetts general hospital. the investigators will evaluate cardiac monitoring utilization calibrated to af risk by stroke neurologists using a custom electronic health record (ehr) notification module. the investigators hypothesize that cardiac rhythm monitoring utilization will be positively correlated with the predicted risk of af.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * presenting with a primary diagnosis of ischemic stroke or transient ischemic attack admitted to massachusetts general hospital inpatient stroke service exclusion criteria: * patients not meeting above inclusion criteria
pharmacokinetics of dexmedetomidine in morbid obesity

Conditions: Obesity

Summary: dexmedetomidine hydrochloride ,a relatively new drug in chinais ,is a highly selective, potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects. the morbid obesity in chinese population is rapidly increasing. but the pharmacokinetics of the drug in these people is still unknown.this research was designed to study the pharmacokinetics of dexmedetomidine in chinese morbidly obese population.

for the obese are sensitive to the disease such as hypertension, ischaemic heart disease and diabetes, the changes of the state may affect the pharmacokinetics of dexmedetomidine. besides,the clearance of dexmedetomidine is parallel with liver function and it is excreted by kidney, so differences in the obese may be expected. about 10 obese patients and 10 matched healthy volunteers with normal weight would be chosen to receive a normal dosage of dexmedetomidine. and venous samples will be collected in different time points. next the investigators can get the plasma concentration of dexmedetomidine by the use of hplc-ms. and then the plasma concentration could be analyzed.

Eligibility criteria:
inclusion criteria: 1. weight:28≦bmi≦45 and 18.5≦bmi≦24 2. written informed consent from the patient or the relatives of the participating patient. exclusion criteria: 1. a previous history of intolerance to the study drug or related compounds and additives. 2. existing significant haematological, endocrine, metabolic or gastrointestinal disease.

Keywords: pharmacokinetics dexmedetomidine obesity
tympanostomy tube placement in children in the office (inova study)

Conditions: Otitis Media

Summary: the objective of the study is to evaluate the safety and efficacy of the acclarent tula tds for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.


Eligibility criteria:
inclusion criteria: 1. scheduled to undergo tympanostomy tube insertion 2. at least 6 months old and younger than 22 years old 3. behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement) 4. no history of sensitivity or reaction to anesthesia chosen for the procedure exclusion criteria: 1. pregnant or lactating females 2. significantly atrophic, bimeric, or completely atelectatic tympanic membrane 3. otitis externa 4. lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal 5. cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane 6. electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.) 7. anatomy that precludes sufficient visualization of and access to the tympanic membrane 8. anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
a study to assess the ability of tramadol, naproxen and oxycodone to affect the pain thresholds of patients with osteoarthritis of the thumb

Conditions: Osteoarthritis Thumbs

Summary: the purpose of this study is to determine if the measurement of pressure pain thresholds, in patients suffering osteoarthritis of the thumb, can be used to assess the activity of potential analgesic agents after a single dose. the study will use agents known to give pain relief in osteoarthritis as positive controls. these agents are: tramadol, naproxen and oxycodone.


Eligibility criteria:
inclusion criteria: * the clinical diagnosis of osteoarthritis of the hand, of at least 6 months duration. * pain around one of the thumb joints due to osteoarthritis. the patient must report the average pain in this joint, in the week prior to screening, as at least 5 on an 11-point numerical pain rating scale at the time of screening. * the patient must demonstrate pressure pain at a thumb joint by reporting a pressure pain threshold lower than 300 kpa. exclusion criteria: * pregnant (as judged by a urine pregnancy test) or lactating female. * other severe pain which may impair the assessment of the pain due to osteoarthritis. * skin condition over the thumb joint, which will be used for pain threshold testing, that could interfere with the assessment of pain thresholds. * known hypersensitivity to oxycodone, nsaids or tramadol. * patients in whom nsaids, oxycodone or tramadol are contraindicated, or patients taking any concurrent medications which are contraindicated with any of the study medications . * an estimated renal clearance of less than 30 ml/min based on the cockcroft gault equation. * use of prohibited medications as listed below, in the absence of appropriate washout periods: * oral or intramuscular corticosteroids within 4 weeks prior to screening. * monoamine oxidase inhibitors within 2 weeks of screening. * analgesic agents, other than aspirin, or acetaminophen within 1 week prior to screening. (aspirin use less than or equal to 325 mg per day for cardiovascular prophylaxis is permitted) * acetaminophen up to 4 g/day may be used, provided it is not used in the 24 hours prior to any assessment of pain thresholds. * intra-articular steroid injections into the study joint within 12 weeks, or to any other joint within 4 weeks, prior to screening. * history of chronic constipation, or of any condition which, in the opinion of the investigator, may put the patient at increased risk of respiratory depression.
exploring ihg training in cr

Conditions: Cardiac Rehabilitation; Blood Pressure

Summary: research has shown that isometric (constant squeeze) exercise training using an isometric handgrip (ihg) device lowers resting blood pressure (bp) in those with and without high bp. the purpose of this study is to explore if ihg training will lower resting bp in people doing cardiac rehabilitation more than doing only cardiac rehabilitation. once eligibility is confirmed participants will be randomly assigned to one of two groups for the study. one group will do ihg training in addition to cardiac rehabilitation (group 1), and the other group will do only cardiac rehabilitation (group 2). participants assigned to group 1 will be asked to do ihg training on their own with an inflatable ball three days per week for 12 weeks with intensity set based on rating of perceived exertion (rpe) or rating of effort. participants will self-measure and report their resting bp to investigators. the acceptability of doing ihg training will also be explored by conducting interviews with participants as will the impact that ihg training may have on psychological wellbeing by administering surveys to participants.


Eligibility criteria:
inclusion criteria: * component adult (greater ≥ 18 years) who can provide informed consent. * proficient in english (speaking, writing, and reading). * medically cleared by the cardiac rehabilitation program to participate in exercise-based cardiac rehabilitation. * history of only coronary artery disease, the most common cardiovascular disease (cvd), which may include individuals with a previous myocardial infarction and/or procedure such as a percutaneous coronary intervention and/or coronary artery bypass grafting. * minimum of "blue" level of technology capability (assigned by the cardiac rehabilitation program) indicating ability to use a phone and email for correspondence. note: the majority of individuals who enroll in the cardiac rehabilitation program are assigned to this level. * no physical limitation(s) that would hinder the performance of isometric handgrip training. * access to a blood pressure monitoring device to record at home measures. exclusion criteria: * if the participant does not meet the inclusion criteria (identified above). * moreover if an individual has a history of a cvd or disease-related complications (e.g., heart failure, atrial fibrillation, ventricular arrhythmias, aortic aneurysm, valve repair and/or replacement) and/or related procedures (e.g., placement of a pacemaker and/or implantable cardiac defibrillator) that is not coronary artery disease (as described in the inclusion criteria) they will be excluded. note: individuals may have other comorbidities.

Keywords: cardiac rehabilitation hand grip training blood pressure
study of the consequences of infection on compliance of modalities of decisions of limitations and stops of treatments (covid-19-lat)

Conditions: Patient Hospitalized in Disease Infectious Unit; Patient Hospitalized in Intensive Reanimation Unit; Patient Hopsitalized in Internal Medicine Unit

Summary: this survey is performed to examine if during the covid's crisis, the practitionner's have respected the modalities of the law about the end of life, in particular concerning limitations and stop of therapeutics

in the current legislativ context notably the clayes leonetti law, a very large majority of icu (intensive care unit) patients die with the establishement of a procedure for the limitation and cessation of therapeutics (lat). during a viral pandemic, medical resources can be saturated, limiting reflexive abilities in favour of binary decisions. this sorting of patients leads to lat that could be performed without the elementary modalities stated by the law. thus, arbitrary medical decisions made alone could expose patients to unjustified " loss of luck ". increasing the resources mobilized during a pandemic must not make us forget the quality of care provided for the benefit of quantity. in therefore seems legitimate to keep the lat modalities to ensure our ethical principles. no work in the literature based on actual facts explores the impact of a pandemic on compliance with and maintenance of ethical principles and the legisltaive framework, in particular as regards the procedures of the application of lat. the purpose of this study is to assess whether the terms of the lat are being complied during a pandemic for patients with or without covid.

Eligibility criteria:
inclusion criteria: * hospitalized major patient * infected or not with covid-19 * having a management with a lat defined by an anticipated or factual restriction of a therapeutic resource ( organ replacement, specific treatment) while his or her state of health requires or may require it, leading or not a death. the patient's death occurs either after a cariac massagewhich corresponds to a maximum management with therapeutic failure or within the framework or in the context of brain death, in these cases there is no lat ; either without cardiac massage and in this case there is de facto a lat wether or not it is performed according to legisltaive procedures. all patients who die will beclassified according to this diagram for the inclusion criterion. for surviving patients, an analysis of the record in search of lat elments will be performed. in the absence of lat elment in the record, i twill be considered that the patient did not have lat and therfore will not be included. exclusion criteria: none

Keywords: covid 19 limitations and stops of processing active therapeutic ethics sanitary crisis