Kornimate/medical-research-clean huggingface dataset:
a clinical study of xin'an medicine in the treatment of bi syndrome

Conditions: Rheumatoid Arthritis

Summary: bi syndrome is one of traditional chinese medicine（tcm）name, it means an obstruction in chinese,and it refers the syndrome characterized by the obstruction of qi and blood in the meridians due to the invasion of external pathogenic wind,cold and dampness, manifested as soreness, pain, numb,etc. bi syndrome contains rheumatoid arthritis(ra). ra is a chronic disease affecting more than 20 million people in the world.it is one of the most common forms of autoimmune disease. xin'an medicine is one of traditional chinese medicine which originated from anhui. xinfeng capsule developed according to the xin'an medicine theory ,and it has long been adopted for treatment of rheumatoid arthritis (ra). the study is aimed to evaluate the effectiveness and safety of xinfeng capsule in the treatment of ra.


Eligibility criteria:
inclusion criteria: * diagnosis of ra, classified by american rheumatism association 1987 revised criteria. * according with the zheng diagnosis of traditional chinese medicine. * age from 18 to 65 years. * for patients currently receiving non-steroidal anti-inflammatory drugs (nsaids): treatment at a stable dose during last 4 weeks prior to screening，or patients do not take nsaids at least 1 weeks prior to screening. * patients not taking dmards at least 4 weeks prior to screening. * patients taking corticosteroids (≤15mg prednisone or equivalent) ≥4 weeks before entering the trial. * patients agree to participate in this study and sign the informed consent form. exclusion criteria: * patients have received intra-articular or systemic corticosteroid injection within 4 weeks of screening. * patients have high disease activity (das28-3 scores\> 5.1). * patients have diagnosed any other chronic inflammatory disease or connective tissue disease like sicca syndrome（ss）, systemic lupus erythematosus (sle)etc; * patients with sever diseases in cardiovascular, brain, lung, liver, kidney and hematopoietic system ; * patients who are pregnant or nursing mothers or psychiatric patients. * patients with active gastroduodenal ulcer or gastritis which caused by long-term use of nsaids; * the patient who has known hypersensitivity to trial medicine . * patients have participated in other clinical trials within 4 weeks of screening.

Keywords: xinfeng capsule; rheumatoid arthritis (ra); randomized; double-blind;
mk0431/ono-5435 phase iii clinical trial -add-on to voglibose study for patients with type 2 diabetes mellitus (mk0431-104)

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: the phase iii clinical trial examines the efficacy, safety, and tolerability of the addition of mk0431/ono-5435 to japanese patients with type 2 diabetes mellitus (t2dm) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy


Eligibility criteria:
inclusion criteria: * japanese patients with type 2 diabetes mellitus, who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy exclusion criteria: * patients have a history of type 1 diabetes mellitus
music vs midazolam during preop nerve block placement

Conditions: Anxiety; Peripheral Nerve Block

Summary: the purpose of this study is to determine if there are differences in anxiety scores, heart rate, blood pressure, and oxygen status when using sedation medication versus music while undergoing a peripheral nerve block before your surgery.

the general flow of the study will be conducted as follows: 1. research coordinator will call or approach patients who are scheduled for a surgical procedure that is planning for a peripheral nerve block either for the primary anesthetic or for postoperative pain control to be placed in the preoperative bay in the ambulatory surgical center. 2. research coordinator will discuss the purpose of our study and explain the study in detail for the patient. if a patient agrees to participate, then we will have the patient sign the informed consent for the study. if patient is on the phone and decides to participate, the patient will sign the informed consent upon arriving to penn medicine university city (pmuc). 3. once the patient signs the informed consent for the peripheral nerve block by anesthesia team. the patient randomized will be revealed to either music or iv midazolam. the pre-procedure anxiety score will then be obtained using the stai-6 validated tool. 4. the golden moment will be conducted between the patient, provider, and nursing staff. once this golden moment is completed, the anxiolytic intervention will start (music or iv midazolam)\* 5. the preoperative nerve block will be conducted by the regional anesthesia block team. 6. once the nerve block is complete, we will obtain the post-procedure anxiety score using the stai-6 validated tool. 7. once the post-procedure anxiety score has been obtained, we will also obtain the patient satisfaction score, the provider satisfaction score, and the evaluation of any difficulties in communication between the provider and patient. after these questions have been obtained, the study is complete.

Eligibility criteria:
inclusion criteria: * patients who are \>18 years of age, who will give informed consent in receiving a peripheral nerve block in the preoperative bay for their primary anesthetic and/or for their postoperative pain control. exclusion criteria: * significant psychiatric disorder such as generalized anxiety disorder, panic disorder, depression, psychosis, bipolar disorder; individuals who were incompetent to give informed consent; pregnant and/or breast feeding patients; any underlying coagulopathy, infection or other factors which would be a contraindication to receiving a peripheral nerve block; hypersensitivity to midazolam; and history of renal impairment. patients who were extremely anxious (scores 50 and greater on the state trait anxiety inventory-6 (stai-6) tool) were also excluded from the study.

Keywords: midazolam
hpa axis activity due to early traumatic stress and metabolic symptoms

Conditions: Childhood Trauma; Major Depressive Disorder

Summary: this study evaluates the association between early trauma, depression and metabolic symptoms.

early traumatic stress is associated with alterations of the hypothalamic-pituitary-adrenal axis (hpa-axis) indicated by an increased response to stress, a diminished negative feedback and alterations in expression of glucocorticoid receptors. patients with a history of childhood trauma are more likely to develop metabolic disorders such as diabetes mellitus type 2 or metabolic syndrome. the investigators will examine participants with and without early life stress and with and without major depression. the investigators assume that traumatized study participants (1) show an increased endocrine stress reaction to psychosocial stress, (2) display an altered sensitivity of gr, and (3) therefore suffer from an adverse cardiovascular risk profile in comparison to not-traumatized participants. the investigators study will increase current knowledge on possible sequel of early traumatic stress. the results will lead to a more comprehensive understanding of stress-related eating behaviour and its implications.

Eligibility criteria:
inclusion criteria: * diagnosis of mdd and/or experience of early trauma exclusion criteria: * severe illness, * control group: no diagnosis of mdd and experience of early trauma
genetics of egfr (epidermal growth factor receptor) mutation study

Conditions: EGFR Mutation Positive Non Small Cell Lung Cancer

Summary: the investigators wish to document the distribution of egfr somatic mutations, and assess the relationship between specific genotype, clinical demographic, therapy, and survival, in a large cohort of egfr mutant nsclc. the investigators also wish to comprehensively investigate the relationship between germline dna and risk of egfr mutant nsclc developing, through a gwas (genome-wide association studies) and candidate gene approach, and explore the relationship between germline dna and clinical outcome, in order to potentially identify germline genetic modifiers of egfr tki (tyrosine kinase inhibitor) outcome.

objective 1: to identify germline allelic dna variation associated with somatic egfr mutation in nsclc, objective 2: correlation between germline allelic variants and survival in egfr somatic mutant nsclc. objective 3: study germline allelic dna variation associated with never /ex light smoking nsclc. objective 4: catalogue distribution of somatic egfr mutant genotypes in 1,000 egfr mutant nsclc cases and describe their relationship to clinical outcome.

Eligibility criteria:
* histologically or cytologically diagnosed nsclc, all histologies are acceptable. * patients can be included in the study with any disease stage and at any time during the disease course. * any type (surgery, radiotherapy, chemotherapy, targeted agents) of previous treatment and any line of treatment are eligible. * age ≥18 years. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial. before patient registration, written informed consent must be given according to ich/gcp (international conference on harmonisation/good clinical practice), and national/local regulations.
study of treatment used for migraine headaches (mk-0974-076)

Conditions: Migraine

Summary: this study will describe the reasons for triptan utilization patterns (continuation and discontinuation) in triptan-naïve participants and assess the stability of treatment utilization patterns over time according to standard medical guidelines or clinical practice standards of the investigating physician.

after study start, the protocol was amended to clarifiy that the first triptan prescription must have been received by the participant within a time window of 3 months (± 2 weeks) prior to the participant being identified by the investigator, and could be enrolled into the study within 6 months of taking the prescribed triptan medication for the first time and that use of a sample triptan would not disqualify a participant as long as the sample was of the same triptan that was eventually prescribed.

Eligibility criteria:
inclusion criteria: * at least 18 years of age in the united states at the time of consent * physician-diagnosed migraine with or without aura * at least two and up to a maximum of 8 moderate to severe migraine attacks during the 30 days prior to screening * initial triptan prescription 3 months (± 2 weeks) prior to being identified as eligible for this study, and triptan-naïve before that initial prescription * used triptan medication at least once within 6 months prior to the date of informed consent for screening * internet access and able to complete online surveys via electronic data entry exclusion criteria: * treated with triptans prior to this study * in active litigation and compensation issues including disability dispute cases with a government agency * participation in a clinical trial within the last 90 days
assessing the preparedness and knowledge of pharmacists in the current monkeypox outbreak

Conditions: Monkey Pox

Summary: general objective: to measure the preparedness of pharmacists and medical interns about monkeypox specific objectives: to evaluate the level of knowledge among pharmacists and medical interns about monkeypox treatment and nature of disease

globally, the ongoing outbreak was declared as a public health emergency. after the first laboratory-confirmed case of monkeypox was reported in singapore on may 2019, countries all over the world started to strengthen disease surveillance systems. one challenge in preventing monkeypox is a lack of knowledge, particularly among healthcare workers. study significance: to examine in detail the preparedness and the perception of pharmacists and medical interns about monkeypox and to evaluate the level of knowledge about monkeypox management and nature of disease.

Eligibility criteria:
inclusion criteria: - community, hospital and clinical pharmacists, medical interns of both sexes exclusion criteria: * any other healthcare professional
prism: patient experiences with pet imaging in prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to examine patient experiences, health-related quality of life, and decision-making associated with pet imaging for prostate cancer. in particular, prostate specific membrane antigen (psma) pet, a new and more sensitive form of imaging that can help identify metastatic cancer earlier and more reliably.

the primary objective is to measure health related quality of life among patients with prostate cancer who are undergoing prostate specific membrane positron emission tomography (psma-pet) imaging. this will be assessed in four domains: cancer related anxiety, decisional conflict, health related quality of life (physical functioning) and health preferences. the secondary objective is to conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on pet imaging. study design investigators will conduct a longitudinal explanatory sequential mixed methods study consisting of two phases. in the first phase, serial quantitative psychological (anxiety, uncertainty) and hrqol survey data from patients undergoing pet imaging in routine clinical care will be collected. in the second phase, a subset of patients from phase 1 who have completed initial surveys will be recruited and conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on pet imaging. patient clinical and sociodemographic data will be collected through automated extraction from the medical record (epic) into the redcap database through collaboration with jdat. for fields that are not populated via automated methods we will manually enter information via abstraction of the patient's medical record (epic).

Eligibility criteria:
inclusion criteria: * documented diagnosis of prostate cancer * scheduled for their first psma pet scan for prostate cancer * english-speaking * willing and able to complete 4 surveys electronically or on paper at 3 timepoints (within 1 month after pet scan, 3-6 months, 12 months) * able to use mobile device (smartphone or tablet) or computer with web access to complete study surveys or able to complete paper surveys exclusion criteria: * lack of access to a mobile device (smartphone or tablet) or computer with web access or unable to receive surveys by mail. * unable to give consent and be enrolled * pet scan is being conducted within a clinical trial
reducing radioisotope dose: the half-dose czt study

Conditions: Coronary Artery Disease

Summary: this is a pilot study to see whether cardiac imaging can be performed using half the standard dose of radioisotope.

the aim of this study is to compare the image quality of the half radioisotope dose scans obtained using a czt (cadmium zinc telluride) camera with scans acquired using a standard of care imaging protocol/radioisotope dose performed on a traditional (conventional) camera. the proposed strategy of a half dose/extended time protocol with the czt camera should yield a similar count activity and consequently image quality equivalent to that detected by a conventional spect system.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age and referred for a clinically-indicated stress spect mpi study * suspected or known coronary artery disease * written informed consent exclusion criteria: * evidence of a normal baseline scan after at least 50% of the protocol acquired baseline scans have been interpreted as being normal * participation in another investigational study within the preceding month * pregnant and/or breast-feeding female * ecg evidence of left bundle branch block or paced rhythm * evidence of non-ischemic cardiomyopathy * presence of hypertrophic cardiomyopathy and/or severe valvular heart disease * severe claustrophobia or inability to lie flat for 20 minutes (the anticipated amount of time to complete the procedure) * known allergy to technetium-99m * potential contraindications to regadenoson use, due to severe lung disease; severe bradycardia (heart rate \< 40 beats/min); second- or third degree atrioventricular heart block; sick sinus syndrome; long qt syndrome; severe hypotension; or decompensated heart failure.

Keywords: coronary artery disease
accuracy of dilution of eus-fna pancreatic cyst fluid for carcinoembryonic antigen (cea) measurement

Conditions: Pancreatic Cyst

Summary: the purpose of this research project is to determine if pancreatic cyst fluid can be diluted and provide an accurate carcinoembryonic antigen (cea) level. the investigators hypothesis is that pancreatic cyst fluid obtained by eus-fna can be diluted effectively and accurately for the measurement of cea levels.

potential subjects will be identified based on the indication of a pancreatic cyst requiring eus-fna. the procedure will be performed as usual per standard protocol with eus-fna of the cyst. once the fluid is aspirated, it will be measured and if the fluid volume is 2.25 ml or greater than the patient will be included in the study. a micropipette will be used to ensure exact volumes are measured. the first 1 ml of cystic fluid will be sent to the lab for regular cea analysis, per standard protocol. the remaining fluid, which would usually be discarded, will then be used for the study. the micropipette will be used to mix 0.75 ml of cyst fluid with 0.25 ml of normal saline (designated sample #2). next, 0.5 ml of cyst fluid will be mixed with 0.5 ml of normal saline for the next study sample (designated sample #3). these two study samples will be sent to the lab separately using de-identified information, and these values will not be part of the patient's medical record and will not affect clinical management or decision-making. the study samples will be given a unique identifier that will not have any patient identification. the unique identifier will allow the study researchers to link the values to the correct patient by using a password protected program that cannot be accessed by the public. this study will not require any additional patient participation, and will not impact the length of the procedure. the only additional time will be from the study researchers and the eus technologists diluting the samples, which will not affect the procedure time itself. if a single patient has more than one cyst, each cyst can be included in the study separately. no additional photographs, videos or data other than the standard data for the procedure will be produced.

Eligibility criteria:
inclusion criteria: * patients scheduled for eus-fna of a pancreatic cyst * cyst must yield 2.25ml (or greater) of fluid exclusion criteria: * cysts yielding less than 2.25ml of fluid

Keywords: pancreatic cyst fluid dilution carcinoembryonic antigen (cea)
actif- assessment of closed tibial fractures

Conditions: Tibial Fractures

Summary: the purpose of this study is to find out the good and bad effects of an investigational drug called cp-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked im nailing procedure


Eligibility criteria:
inclusion criteria: * males or females 17 years or older with confirmed closure of the tibial epiphyses, with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked im nailing procedure and the absence of an associated compartment syndrome or vascular injury; * closed tibial fractures types a, b \& c (see ota fracture classification) can be included. exclusion criteria: * previous fractures of the same tibia that may impact nailing procedure or impaired visibility of current fracture or a history of osteomyelitis; * subjects with any other clinically significant injuries, which may significantly impair weight bearing of the affected limb; * subjects with a fracture gap of \>1cm after initial surgery and prior to drug administration; * any other planned invasive or non invasive interventions intended to promote bone healing of the tibial fracture under study are not allowed in the first 24 weeks after treatment.
examining self-tracking behaviors in a mobile intervention for binge eating and weight management

Conditions: Obesity; Binge Eating

Summary: the purpose of this study is to understand users' experiences and interests completing self-tracking in a mobile intervention for binge eating and weight management.


Eligibility criteria:
inclusion criteria: * adults age 18 years or older * obesity (bmi ≥30) * recurrent binge eating (≥12 episodes in the past 3 months) * interested in losing weight and reducing binge eating * willing to use a mobile application * willing to practice self-monitoring * has access to a scale * not pregnant * english-speaking exclusion criteria: * none
a study of ly2951742 (galcanezumab) in japanese participants with episodic migraine

Conditions: Migraine

Summary: the main purpose of this study is to determine the efficacy of the study drug galcanezumab in japanese participants with episodic migraine.


Eligibility criteria:
inclusion criteria: * have a diagnosis of migraine as defined by international headache society (ihs) international classification of headache disorders (ichd)-3 beta guidelines (1.1 or 1.2) (ichd-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50. exclusion criteria: * are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. * current use or prior exposure to galcanezumab or other antibodies to cgrp or its receptor. * known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab and the excipients in the investigational product. * history of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by ihs ichd-3 beta.

Keywords: prevention prophylaxis headache
use of ketorolac in management of post-operative pain after heart surgery

Conditions: Pain Management Following Cardiopulmonary Bypass Surgery

Summary: this study evaluates the safety and efficacy of ketorolac for post-operative pain management after heart surgery. ketorolac appears to provide enhanced pain relief while also decreasing the requirements for morphine during the (immediate) 24-hour post-operative period.

current practice at this institution does not include routine use of ketorolac for post-operative pain management of patients undergoing cardiac surgery. the investigators hypothesize that using ketorolac as an adjunct to iv morphine can positively impact patient outcomes and reduce the occurrence of possible side effects.

Eligibility criteria:
inclusion criteria: * males and females \> 18 years of age at the screening visit. * undergoing coronary artery bypass graft or single valve repair or replacement requiring cardiopulmonary bypass. * american society of anesthesiology (asa) physical class 3, or 4. * willing able to use a pca pump * willing to receive iv morphine for 24 hours post initial ketorolac dose to control pain. * capable of speaking and understanding english sufficiently to provide written informed consent and responses to pain assessment scales and neurological questionnaires. exclusion criteria: * allergy or sensitivity to nonsteroidal anti-inflammatory drugs * history of gastrointestinal bleeding or peptic ulcer * serum creatinine = 2.0 mg/dl or rise in serum creatinine of = 0.5 mg/dl or 25% within the preceding 10 days if known with the exception of patients with dialysis dependent end stage renal disease (esrd). * hepatic dysfunction * patients with low cardiac output syndrome (cardiac index \< 2.0) after cardiopulmonary bypass or pre-op ejection fraction \< 30% * inability to operate pca pump * cardiothoracic reoperations * bleeding disorder

Keywords: ketorolac