Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of the quickfix small staple

Conditions: Hallux Valgus Interphalangeus

Summary: the prospective, post-market, single-center clinical study will include 45 subjects who are candidates for surgery using the arthrex quickfix small staple for akin osteotomy to correct hallux valgus interphalangeus. the purpose of the study is to evaluate the continued safety and effectiveness of the device. device-related adverse events as well as patient reported outcomes (vas, ffi, faam, vr-12) will be collected up to 1 year postoperative.


Eligibility criteria:
inclusion criteria: 1. subject requires surgery using the arthrex quickfix small staple for akin osteotomy. 2. subject is 18 years of age or older. 3. subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state). 4. subject signed informed consent and is willing and able to comply with all study requirements. exclusion criteria: 1. insufficient quantity or quality of bone. 2. blood supply limitations and previous infections which may retard healing. 3. foreign-body sensitivity. 4. any active infection or blood supply limitations. 5. conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period. 6. subjects that are skeletally immature.

Keywords: staple
hypoglycemia: physician and patient perspectives

Conditions: Type 2 Diabetes Mellitus; Hypoglycemia

Summary: the purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among type 2diabetes mellitus (t2dm) patients on oads and/or insulin. this is an observational study which will identify patients with t2dm in an administrative claims database and will link claims data with results of patient and physician surveys concerning hypoglycemia.


Eligibility criteria:
inclusion criteria: * t2dm claims diagnosis (algorithm-based) with at least 2 pharmacy claims for an antidiabetic drug * at least 1 hba1c test recorded during the identification period * continuous enrollment in the health plan for at least 12 months prior to survey date exclusion criteria: * type 1 diabetes mellitus * pregnancy or gestational diabetes

Keywords: type 2 diabetes mellitus hypoglycemia
health communication to influence covid-19 vaccination intent and message propagation

Conditions: COVID-19; Respiratory Disease; Vaccine Refusal; Infectious Disease; Coronavirus Infections; Behavior, Health; Pneumonia; Respiratory Tract Infections; Lung Diseases; Pneumonia, Viral

Summary: this is a randomised controlled experiment in the form of a web based survey study which randomly exposes participants to different forms of public health messages, after which participants will be assessed on their intent to take up the covid-19 vaccine, recommend the vaccine, and also willingness to propagate the exposed message.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent for participation in the trial * malaysian nationality. * can understand either the english or malay language. * aged 18 years or above exclusion criteria: * received at least one covid-19 vaccination dose

Keywords: message messaging propagation intent vaccine recommend
cognitive performance after a night shift in internal medicine residents

Conditions: Sleep Deprivation; Burnout, Professional; Cognition Disorders

Summary: a quasi-experimental design where internal medicine residents in a high complexity hospital were assessed after a 24-hour shift for cognitive impairment by a trained neurologist.

the investigators conducted a cross sectional study during the 2014-2016 period in a high complexity school hospital in buenos aires. second and third year internal medicine residents who consented to participate were included. a neurologist conducted a cognitive evaluation to the residents who had done 24 hours shifts (with sleep deprivation) within 6 hours of its end. auditory memory deficit was evaluated (pasat - paced auditory serial addition test), verbal fluency (fas), direct and indirect digit-span, rey auditory verbal learning test (ravlt) and continuous performance test 2 (cpt2). results were presented as means of standardized scores (z score) with their interquartile range (iqr).

Eligibility criteria:
inclusion criteria: * internal medicine residents on the second or third year of formation. exclusion criteria: * denial to participate in the study or to the informed consent.

Keywords: sleep deprivation internal medicine residency on call cognitive impairment burn out safety depression
zolmitriptane as prophylaxis for chilhood migraine

Conditions: Migraine

Summary: zolmitriptane can be tried as prophylactic therapy of childhood migraine

90 children with migraine included in the study first group 30 received zolmitriptane second group 30 received topiramate third group 30 received valproate

Eligibility criteria:
inclusion criteria: children with migraine - exclusion criteria: those who suffer from ischemic heart disease , or who have allergy to any of drugs used -
are mindfulness programs in the workplace effective at reducing stress

Conditions: Mindfulness; Occupational Stress

Summary: the objective of this study is to determine whether a mindfulness coaching program was efficacious at reducing work stress, improving psychological and physical health outcomes, and improving work outcomes. the target population is employed adults (18 years and older) working in the industries of media, consulting, and healthcare.


Eligibility criteria:
inclusion criteria: * employees who are eligible to take the company's health risk assessment and/or biometric screening * employees who are eligible for medical health benefits exclusion criteria: -

Keywords: resilience, psychological energy level empathy emotional intelligence satisfaction with relationships happiness sleep quality physical health presenteeism focus collective efficacy job satisfaction job engagement
gsk189075, gw869682 or placebo in type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2; Non-Insulin-Dependent Diabetes Mellitus

Summary: this is a study to compare the safety, blood concentrations, and effects of gsk189075, gw869682, and placebo when dosed for 2-weeks by mouth to patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes. * hba1c (a measure of the average amount of sugar in blood over the last 2 or 3 months) levels are between 7.0 and 9.0. * taking 850mg or more per day metformin, but not taking any other diabetes medications. * must be medically able and willing to discontinue diabetic medications from at least 2 weeks prior to first study dose until the last study assessment. * diabetic subjects who have not yet started taking diabetes medications or whose diabetes is controlled by diet alone may also be eligible to enroll if their hba1c is within 7.5 to 9.0. * women may be eligible if they are post-menopausal or surgically sterile. * if taking ace inhibitors, beta-blockers, calcium channel blockers, or statin type drugs, you may be eligible if your dose has been stable for at least 30 days prior to the start of the clinical trial. exclusion criteria: * using illicit drugs, or have antibodies to hepatitis b, hepatitis c, or hiv. * have any major health problems other than type 2 diabetes. * require insulin therapy or oral antidiabetic medication other than metformin. * subjects who have had a urinary tract infection within 4 weeks of the start of the study or who have kidney disease. * subjects with either low or high blood pressure. * men who are unwilling to abstain from intercourse, or use a condom with a pregnant or nursing female, or who are unwilling to use a condom with another form of contraception with a female who could become pregnant.

Keywords: diabetes sodium dependent glucose transporter sglt2 gsk189075 gsk189074 sglt1 gw869683
a study to assess the efficacy and safety of alefacept in psoriasis patients for whom conventional treatment is ineffective or inappropriate

Conditions: Chronic Plaque Psoriasis

Summary: to assess the efficacy and safety of alefacept compared to placebo for the treatment of chronic plaque psoriasis in patients for whom conventional therapies are ineffective and inappropriate

patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension

Eligibility criteria:
inclusion criteria: * diagnosis of chronic plaque psoriasis involving ≥ 10% body surface area * treatment history for psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective * cd4+ t lymphocyte counts at or above the lower limit of normal exclusion criteria: * clinically significant abnormal hematology values or blood chemistry values * ast or alt ≥ 3x the upper limit of normal * other types of psoriasis * serious infection within the 3 months prior to the first dose of study drug * history of drug or alcohol abuse within the past 2 years * antibody positive for hiv * history of malignancy * history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease * exposure to psoriasis-modifying phototherapy or high-potency topical corticosteroid therapy within 2 weeks prior to the first dose of study drug * exposure to systemic anti-psoriatic therapy , topical immunomodulators or topical cnis within 4 weeks prior to the first dose of study drug * current treatment with any therapy for tuberculosis * previous exposure to alefacept * nursing mothers, pregnant women, and women planning to become pregnant during the study

Keywords: chronic plaque psoriasis alefacept
comparison of iv ergonovine with im carboprost, with oxytocin iv, during cesarean section for failure to progress

Conditions: Postpartum Hemorrhage

Summary: patients having cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective cesarean section. the investigators believe a simple change in practice might contribute to reduce this bleeding. this study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. this study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during cesarean sections following a trial of labour.

the objective of the investigators study is to compare the efficacy of intravenous ergonovine and intramuscular carboprost, when administered with oxytocin infusion, prophylactically to decrease blood loss at cesarean section for labor arrest. desensitization of the oxytocin receptors has been recently demonstrated in cultured human myometrial cells after continuous and prolonged exposure to oxytocin in-vitro. this could be also the reason for a greater risk of uterine atony and postpartum hemorrhage (pph) seen in women requiring induction and augmentation of labor. therefore, addition of a different uterotonic agent, involving a different mechanism of action, to oxytocin infusion is likely to be beneficial, especially in women undergoing cs following failure to progress in labor, who are at a greater risk for pph.

Eligibility criteria:
inclusion criteria: * patients who give written informed consent * patients undergoing cesarean section for failure to progress in labour, under regional anesthesia * patients should be in the first stage of labour and have received oxytocin for at least 4 hours exclusion criteria: * patients who refuse to give written informed consent * patients who require general anesthesia * patients who claim allergy or hypersensitivity to oxytocin, ergot derivatives or prostaglandins * patients with cardiac diseases and hypertension or preeclampsia ( diastolic blood pressure \> 90 mmhg, systolic blood pressure \> 140 mmhg ) * patients with asthma or any other respiratory disease * patients with conditions at risk of pph such as placenta previa, multiple gestation, preeclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, bleeding diathesis and known infection.

Keywords: pregnancy postpartum hemorrhage cesarean delivery failure to progress in labor
assessing nhs implementation of an online resilience training acceptance and commitment therapy (act) programme to prevent job loss in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: people with ms (pwms) are at increased risk of leaving work earlier than expected. psychological factors that affect pwms may make it more difficult to manage staying in work. these can include psychological flexibility and self efficacy. psychological flexibility is the ability to effectively manage unwanted inner experiences (e.g., thoughts, memories, bodily sensations) in the present. self-efficacy is the self-belief that an individual has in their ability to succeed.

acceptance and commitment therapy (act) may help improve psychological flexibility and self-efficacy. researchers and pwms at leeds have recently co-developed an online act-type programme called 'ready for ms'. this online programme may be helpful for pwms who want to stay in work. ready for ms can be used on a computer or mobile device and does not need time off work traveling to see a psychologist. the aim is to understand the feasibility and effectiveness of training ms healthcare professionals to support delivery of the ready programme. also to understand the long-term outcomes for both healthcare professionals and the pwms they are supporting. what contexts contribute to effective delivery of the ready for ms programme will be explored. the aim is to test this ready for ms programme in various nhs settings to ensure that the programme is delivering the outcomes expected. this is a concept referred to as 'intervention fidelity'. the key outcome that will be measured for pwms is work instability (i.e. risk of job loss). participants will be invited to complete online questionnaires. these will be completed at baseline, post-intervention and 6 month follow-up. the study team will invite a sub-set of participants to complete semi-structured interviews. the study team will use regular rapid qualitative analysis methods (lightning reports) to assess implementation.

Eligibility criteria:
inclusion criteria: * participants capable of giving informed consent * age 18 years or above * currently in paid employment with an intention to remain in employment for at least 6 months * phase 2: a registered healthcare professional or allied health professional who works in direct contact with patients diagnosed with multiple sclerosis or * phase 3: an individual with a clinical diagnosis of multiple sclerosis and reporting a wi score ≥11/22 (on ms-wis) exclusion criteria: * individuals lacking capacity to give informed consent * individuals intending to leave paid employment within the next 6 months * individuals who will not have access to a device used to access the internet (e.g. laptop or smartphone) for the duration of study participation
study of adalimumab in participants with peripheral spondyloarthritis (spa)

Conditions: Peripheral Spondyloarthritis

Summary: the objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (sc) compared to placebo for 12 weeks followed by open label (ol) safety and efficacy assessments in participants with non-ankylosing spondylitis (as), non-psoriatic arthritis (psa) active peripheral spondyloarthritis (spa) who have had an inadequate response to \>= 2 non-steroidal anti-inflammatory drugs (nsaids), or are intolerant to, or have a contraindication for, nsaids.


Eligibility criteria:
inclusion criteria: * adult participants who had inadequate response to \>= 2 non-steroidal anti-inflammatories (nsaids) * participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria * negative purified protein derivative (ppd) test and chest x-ray performed at baseline visit were negative * ability to administer subcutaneous injections * general good health exclusion criteria: * prior anti-tumor necrosis factor (tnf) therapy * psoriasis or psoriatic arthritis * fulfillment of modified new york criteria for ankylosing spondylitis * recent infection requiring treatment * significant medical events or conditions that had put patients at risk for participation * female participants who were pregnant or breast-feeding or considering becoming pregnant during the study * history of cancer, except successfully treated skin cancer * recent history of drug or alcohol abuse

Keywords: peripheral spondyloarthritis adalimumab humira
effect of soy isoflavones on bone mineral density and physical performance indices

Conditions: Osteoporosis

Summary: the aim of the present study was to investigate the effects of soy and soy plus isoflavones on bone mineral density and physical performance in post menopausal women.

post menopausal estrogen deficiency causes physiologic changes in body composition including decreased lean body weight and bone mass. a decrease in muscle strength along with osteoporosis puts post menopausal women at a high risk of hip fractures causing considerable mortality and morbidity. estrogen use has been shown to reduce bone density loss and increase muscle strength but given the concerns regarding its use, patients are looking for alternatives such as soy isoflavones. most human studies on the effect of soy on bone mineral density (bmd) in post menopausal women have been short term i.e. 3-6 months and failed to provide conclusive evidence. there is no evidence of its effects on physical performance. the aim of the present study is to investigate the effects of 25g of soy protein alone or with 90mg of isoflavones on bone mineral density and physical performance indices in post menopausal women over a duration of 2 years.

Eligibility criteria:
inclusion criteria: * at least 55-75 years of age * at least 7 years post menopausal either spontaneous or surgical exclusion criteria: * must not have used estrogen for atleast 2 months prior to entering study * must be on no bone active drugs such as bisphosphonates, anti convulsants, calcitonin and long term steroids * osteoporosis (t-score\<-2.5) * bmi \ 34

Keywords: soy isoflavones, bone mineral density, post menopausal women
pharmacokinetic drug interaction study of dapagliflozin and glimepiride or sitagliptin in healthy subjects

Conditions: Type 2 Diabetes Mellitus

Summary: to assess the effect of glimepiride on the pk of dapagliflozin and the effect of dapagliflozin on the pk of glimepiride, when co-administered in healthy subjects (phase a) and to assess the effect of sitagliptin on the pk of dapagliflozin and the effect of dapagliflozin on the pk of sitagliptin, when co-administered in healthy subjects (phase b)


Eligibility criteria:
inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m2, inclusive bmi = weight (kg)/\[height(m)\]2 exclusion criteria: * wocbp who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product * abnormal liver functions tests (alt, ast or total bilirubin \> 10% above uln) * history of chronic or recurrent uti (defined as 3 occurrences per year) or uti in the past 3 months * history of allergy to sglt@ inhibitors, dpp$ inhibitors or sulfonylurea or related compounds * prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of day -1 * history of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
long-term follow-up study of patients with osteoarthritis of the knee treated with ubx0101 or placebo

Conditions: Knee Osteoarthritis

Summary: a follow-up study to assess the long-term safety of intra-articular (ia) administration of ubx0101 in patients with painful knee osteoarthritis (oa).

this is a blinded, multi-center study to provide approximately 1 additional year of follow-up for patients with knee oa who participated in a randomized placebo-controlled study of ia ubx0101. no intervention is planned and patients will have 4 scheduled visits to collect follow-up assessments. the primary objective is to evaluate long-term safety and tolerability of ia administration of ubx0101 in patients with painful knee oa.

Eligibility criteria:
inclusion criteria: * patients with knee oa who have completed a randomized placebo-controlled study of ubx0101. * patients who are willing and able to consent to having blinded, long-term follow-up; consent via legally authorized representative is not accepted. exclusion criteria: * patients with any condition that, in the opinion of the investigator, would likely interfere with adhering to the study schedule of visits for 12 months. * patients who are scheduled to undergo knee arthroplasty on either knee during the study. * patients who anticipate arthroscopic surgery on either knee at any time during the study. * patients who plan to receive treatment with an anti-nerve growth factor agent during the study. * patients who plan to participate in another investigational study (including interventional studies of investigational drugs and investigational treatments \[e.g., braces, stem cells, and procedures\]) during the study.

Keywords: osteoarthritis painful osteoarthritis osteoarthritis, knee senescence