Kornimate/medical-research-clean huggingface dataset:
ranolazine and microvascular angina by pet in the emergency department

Conditions: Microvascular Angina

Summary: the purpose of this study is to determine the effectiveness of ranolazine for the treatment chest pain from disease of small vessels of the heart also known as 'microvascular angina'.

the yale chest pain center (cpc) is a unique clinical lab that provides an integrated interdisciplinary research team, access to high volume of chest pain patients largely free of coronary disease (93%) as well state of the art diagnostics including cardiac pet and a sophisticated system for serum processing and banking facilities. the cpc cohort represents a unique population with unrecognized microvascular disease and is often only accessible through the ed. we propose a one-year pilot study to understand the mechanisms of angina relief by ranolazine (n=20) in patients with microvessel disease in the ed population as compared to controls (n=10) at baseline and at 1-month. in addition, changes in pain scores and function as measured by seattle angina questionnaire (saq), recidivism and costs will be measured and correlated with changes in coronary flow reserve (cfr). serum samples will be obtained and banked for future marker analysis as intermediate surrogates of outcomes. primary aim: to compare changes in coronary flow reserve as measured by cardiac pet in patients receiving ranolazine versus controls. secondary aim: to determine if ranolazine changes seattle angina questionnaire (saq) scores in association with changes in coronary flow reserve (cfr) versus controls. exploratory aim: to compare composite rate of return visits (office, emergency department and hospitalization) for chest pain within 4-weeks of enrollment between patients with and without ranolazine.

Eligibility criteria:
inclusion criteria: * patients admitted to the yale ed cpc * ≥ 30 years age * chest pain or angina equivalent as their chief complaint within 24 hours of enrollment * coronary flow reserve(cfr) \<2.5 on pet scan in the ed. exclusion criteria: * acute coronary syndrome * prior evidence of obstructive heart disease (history of percutaneous transluminal coronary angioplasty (ptca), coronary artery bypass grafting (cabg) or calcium score \> 10 on pet scan) * resting blood pressure of systolic \>180/110 mm hg or \<100/40 * known cardiomyopathy or heart failure * currently on dialysis * creatinine clearance \<30 ml/min * liver cirrhosis * significant aortic stenosis (murmur on exam) * active use of cocaine or amphetamine * current use of potent cyp3a4 inducers or inhibitors (such as ketoconazole, clarithromycin, hiv protease inhibitors) * baseline qtc \> 580 msec * use of drugs that prolong qtc (haldol, erythromycin) * pregnancy * inability to read or understand english * suffering from a condition that precludes interview (i.e. cognitive or communication impairment).

Keywords: chest pain microvascular angina ranolazine emergency department pet
clinical trial to evaluate efficacy and safety of multiple subcutaneous injections of various doses of bcd-085 in patients with active ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: bcd-085-3 is a next step in clinical investigation of bcd-085. bcd-085 is a monoclonal antibody to interleukin 17. during the trial patients with active ankylosing spondylitis will receive 40, 80 or 120 mg of bcd-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12. efficacy and safety parameters will be evaluated.


Eligibility criteria:
inclusion criteria: * written informed consent * age between 18 and 65 years * active ankylosing spondylitis according to modified criteria of new york classification (1984), that was diagnosed at least 3 months prior to screening. * active disease according to basdai (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening. * mean backache intensity equals 4 points or more. * if patient have had biologic therapy to treat ankylosing spondylitis for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. this therapy must be discontinued at least 12 weeks before enrollment in the study. * female patients have negative urine pregnancy test. * patient has no history of tuberculosis. * patients have negative results of diaskintest. * patient has no history of alcohol or drug abuse. exclusion criteria: * total spinal ankylosis. * allergy or intolerance of monoclonal antibodies or any excipients of study drugs. * previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs. * prior use of two or more biologics to tumor necrosis factor alfa. * prior use of two or more biologics to other targets. previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent. * patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable. * prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization, if their dose was not stable for up to 4 weeks before signing informed consent and during screening. * prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent. * prior use of alkylating agents for up to 12 months prior to signing informed consent. * intraarticular use of corticosteroids for up to 4 weeks before randomization.

Keywords: ankylosing spondylitis interleukin 17 monoclonal antibody
characterizing igg4-rd with 68ga-fapi pet/ct

Conditions: IgG4-related Disease

Summary: 68ga-fapi has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as igg4-related disease.and it might be more sensitive than fdg in detecting a certain type of inflammations according to our preliminary research.thus this prospective study is going to investigate whether 68ga-fapi pet/ct may be superior for diagnosis, therapy response assessment and follow-up of igg4-related disease.

immunoglobulin g4-related disease (igg4-rd) is an immune-mediated fibroinflammatory condition that is capable of affecting multiple organs. common forms of presentation include:type 1 (igg4-related) autoimmune pancreatitis (aip)，igg4-related sclerosing cholangitis, major salivary gland enlargement or sclerosing sialadenitis; orbital disease, often with proptosis and retroperitoneal fibrosis. the involved organs share a number of core pathologic features and striking clinical and serologic similarities, including tumor-like swelling of involved organs, a lymphoplasmacytic infiltrate enriched in igg4-positive plasma cells, and a variable degree of fibrosis that has a characteristic "storiform" pattern. 68ga-fapi has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and it might be a pan-tumor pet agent. recently we have reported a case of igg4-related disease revealed by 68ga-fapi and 18f-fdg pet/ct which showed fapi was not more tumor-specific than fdg, furthermore,it might be more sensitive than fdg in detecting a certain type of inflammations-like the pancreatic lesion. thus this prospective study is going to investigate whether 68ga-fapi pet/ct may be superior for diagnosis, therapy response assessment and follow-up of igg4-related disease.

Eligibility criteria:
inclusion criteria: * suspected or confirmed untreated igg4-rd patients; * 18f-fdg pet/ct within two weeks; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * known allergy against fapi * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
effectiveness of thyme honey in management of xerostomia in post radiation cancer patients

Conditions: Head and Neck Cancer Patients

Summary: xerostomia is the most frequent complication among patients who receive radiotherapy (rt) . the prevalence of xerostomia has been reported to be from 73.5% to 93% (kakoei s.,2012). damage to normal tissues can result by radiotherapy as it is not selective to cancer cells, and so affecting the quality of life of patients. honey is one of the methods studied by cim for management of hnc treatment side effects due to its properties. (brennan et al., 2002; clarkson et al., 2007; furness et al., 2011;hackett et al., 2015). thyme honey is a new alternative for management of xerostomia, which is a propolis gel product. thyme honey is a variety of monofloral honey made from the nectar and pollen of thyme flowers. it has a strong antioxidant, antibacterial, antifungal and immuno modulating health effects. due to the high sugar concentration in honey, it is believed that its presence in the oral cavity has a sialogogue effect, stimulating the salivary glands to produce saliva.

28 post radiation cancer patients were randomly assigned into two equal groups.the intervention group will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. patients in the control arm followed the same protocol with normal saline rinses. the treatment assessment of subjective dry mouth score, objective dry mouth score, salivary ph and salivary flow rate will be carried out at baseline, 2 weeks and one month after starting of the treatment protocol (charalambous et al., 2017). nitric oxide levels will be measured at baseline and after one month of treatment (abadi et al., 2020).

Eligibility criteria:
inclusion criteria: * patients referred to non-palliative head and neck radiotherapy * total dose of radiation received (50-70 gy) * patients with complaint of xerostomia * age 25-65 years old * objective dry mouth score from ( 2-5) * subjective dry mouth score from (1-4) * undergoing radiotherapy for at least three weeks * can independently complete the questionnaire exclusion criteria: * have confirmed systemic diseases or medications associated with xerostomia * have a known allergy to honey * patients who had salivary glands removal surgery * patients with salivary gland diseases or malignancy * vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.

Keywords: xerostomia thyme honey nitric oxide
endoscopic-assisted microsurgical removal of cerebellopontine angle lesions

Conditions: Cerebellopontine Angle Tumor

Summary: it is a prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions to estimate the following : 1. intraoperative judgement of lesions excision, residual parts, visualization and operative corridor pre and after endoscope introduction. 2. post-operative tumor control confirmed comparison between pre and postoperative mri. 3. postoperative complications, advantages and disadvantages compared with these when use pure microscopic excision from the literature


Eligibility criteria:
inclusion criteria: cerebellopontine angle lesions * meningeoma. * vestibular schwannoma. * arachnoid cyst. * petroclival meningeoma. exclusion criteria: * trigeminal neuralgia. * facial neuralgia.
aggressive medical treatment evaluation for asymptomatic carotid artery stenosis

Conditions: Carotid Artery Stenosis; Atherosclerosis; Stroke

Summary: the aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.

it is well known that risk of fatal and non-fatal stroke is increased in patients with significant carotid atherosclerosis. for asymptomatic patients, aha guidelines recommend carotid endarterectomy (cea) for stenosis 60% to 99%, if the risk of perioperative stroke or death is less than 3%. although clinical trial data support cea in asymptomatic patients with carotid stenosis 60% to 79%, the aha guidelines indicate that some physicians delay revascularization until there is greater than 80% stenosis in asymptomatic patients. our study is designed to determine whether optimal medical therapy alone reduces the risk of death and nonfatal stroke in patients with carotid artery stenosis as compared with cea coupled with optimal medical therapy.

Eligibility criteria:
inclusion criteria: * unilateral or bilateral carotid artery stenosis that was considered to be severe (carotid artery diameter reduction 70%-79% on ultrasound) * this stenosis had not caused any stroke, transient cerebral ischaemia, or other relevant neurological symptoms in the past 6 months * both doctor and patient were substantially uncertain whether to choose immediate cea, or deferral of any cea until a more definite need for it was thought to have arisen * the patient had no known circumstance or condition likely to preclude long-term follow-up * neurologist's explicit consent to potentially perform cea exclusion criteria: * previous ipsilateral cea * expectation of poor surgical risk (e.g., because of recent acute myocardial infarction) * some probable cardiac source of emboli (because the main stroke risk might then be from cardiac, not carotid, emboli) * inability to provide informed consent * underlying disease other than atherosclerosis (inflammatory or autoimmune disease) * life expectancy \< 6 months * advanced dementia * advanced renal failure (serum creatinine \> 2.5 mg/dl) * unstable severe cardiovascular comorbidities (e.g., unstable angina, heart failure) * restenosis after prior cas or cea * atrial fibrillation * allergy or contraindications to study medications (statins, asa, losartan, amlodipine)

Keywords: internal carotid artery stenosis carotid endarterectomy stroke cerebrovascular atherosclerosis
exploring beliefs and behaviors about weight loss in couples

Conditions: Obesity

Summary: this study explores among couples in which both members are obese how the use of mental contrasting along with implementation intentions influence intentions and behavior related to weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons (i.e., mediators) why these changes may occur (e.g., social support, changes in beliefs about weight loss, confidence in being able to eat healthy and diet).

this study explores among couples in which both members are obese how the use of mental contrasting along with implementation intentions influence intentions and behaviors related to weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons (i.e., mediators) why these changes may occur (e.g., social support, changes in beliefs about weight loss, confidence in being able to eat healthy and diet). in mental contrasting procedures, people first imagine a desired future (e.g., eating healthy) and then reflect on the current negative reality (e.g., i snack too much). this process makes people aware of changes needed in the present to obtain future positive outcomes, and thus aids in increasing goal commitment and goal pursuit. in implementation intention procedures, individuals form "if-then" statements about how they will enact their goals in their everyday lives. implementation intentions are highly effective at helping individuals achieve health behavior change. recent studies suggest that the combined use of mental contrasting and implementation intentions produce more behavior change than either technique alone (e.g., diet) in this study, investigators test whether these procedures vary in their effectiveness when couple members are instructed to focus on themselves versus the relationship, the latter intended to instill a communal coping mindset (i.e., that losing weight is an issue that needs to be addressed as a couple enacted through mutually cooperative behaviors).

Eligibility criteria:
inclusion criteria: * married couples or couples living as married * living in the same household for at least six months * both members of couple are obese (bmi \> 30). * must be 18 years or older * can read and write in english

Keywords: mental contrasting weight loss obese couples obesity overweight planning health diet exercise physical activity goal goal-setting
plasma triglyceride extraction by the muscle

Conditions: Obesity; Insulin Resistance

Summary: increased accumulation of fat into the muscles is associated with what is called insulin-resistant state, which is a pre-diabetic state. the purpose of this research is to find out how fat circulating in the blood following fat consumption is taken up by the muscles in healthy people as well as people that are insulin-resistant. the investigators are specifically interested in how a hormone called insulin is involved in this process. findings from this research will contribute to our understanding of why insulin-resistant people have increased accumulation of fat in their muscles, and ultimately help to design appropriate interventions to prevent type 2 diabetes.


Eligibility criteria:
inclusion criteria: * body mass index (bmi): \ 30 kg/m2; * insulin sensitivity index (isi): insulin-sensitive isi ≥ 7, insulin-resistant isi ≤ 5. exclusion criteria: * medication or supplements known to affect either endothelial function or lipid metabolism (i.e. arginine, protein, fish oil) * acute illness * uncontrolled metabolic disease, including liver or renal disease * atrial fibrillation, history of syncope, limiting or unstable angina, congestive heart failure, known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts * cardiac pacemaker or other medical device implanted in the body * pulmonary hypertension or other unstable cardiopulmonary conditions * ecg documented abnormalities or valvular disease * low hemoglobin or hematocrit (i.e., lower than accepted laboratory values) * history of hypertension or elevated blood pressure (systolic, \>140 mmhg or a diastolic, \>95 mmhg) * history of hyperlipidemia or plasma triglyceride concentration \>200 mg/dl * diagnosed diabetes, or 2-h plasma glucose \>200 mg/dl during an oral glucose tolerance test * current participation in a weight-loss regimen, including extreme dietary practices * use of anabolic steroids or corticosteroids (within 3 months)
a trial to learn how well regn9933 and regn7508 work for preventing blood clots, and how safe they are, in adults who have a peripherally inserted central catheter (picc)

Conditions: Venous Thromboembolism

Summary: this study is researching 2 different experimental drugs called regn9933 and regn7508 (called "study drugs"). the study is focused on adults undergoing a placement of a catheter in the vein, also called a 'picc line'. the aim of the study is to see how effective the study drug is at preventing venous thromboembolism (vte) and other related disease after catheter placement. the study is looking at several other research questions, including: * what side effects may happen from taking the study drug * how much study drug is in the blood at different times * whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. picc is anticipated to remain in place for at least 14 days 2. eastern cooperative oncology group (ecog) performance status ≤2 or equivalent functional status as described in the protocol 3. body weight ≥50 kg and ≤130 kg during the screening period 4. international normalized ratio (inr) and aptt values at or below the upper limit of normal as defined by the local lab during the screening period 5. platelet count ≥100 x 10\^9/l during the screening period as described in the protocol key exclusion criteria: 1. unsuccessful picc placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant 2. history of prior venous thrombosis in the arm in which the picc is to be placed 3. peripheral catheter(s) in the same arm in which the picc is to be placed or expected need for peripheral catheter(s) placement in the same arm the picc is to be placed as described in the protocol 4. history of known thromboembolic disease or thrombophilia 5. participants requiring therapeutic or prophylactic anticoagulation and/or antiplatelet therapy as described in the protocol 6. expected to receive cancer therapy or other medication associated with a prior episode of grade 4 thrombocytopenia as described in the protocol 7. any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (such as but not limited to hemophilia a or b, von willebrand's disease, fibrinogen deficiency, and other inherited or acquired bleeding disorders) note: other protocol defined inclusion/exclusion criteria apply

Keywords: anti-factor xi (fxi) monoclonal antibody venous thromboembolism peripherally inserted central catheter
correlation of toxins with gastrointestinal (gi) and overall health

Conditions: Gastrointestinal Diseases

Summary: the goal of this observational study is to evaluate the levels of urinary environmental toxins, heavy metals, pfas and mycotoxins with gastrointestinal (gi) and overall health.

this study aims to use urine samples to understand the effect of toxins such as environmental toxins, heavy metals, pfas and mycotoxins on gi and overall health. urine samples will be tested using mass-spectroscopy-based techniques. a 'total toxicity score' will be calculated based on the urine analysis of toxins. a 'symptoms score' will be determined using the 'symptom history' form which will be used to assess the patient's gi conditions. additionally, a 'diagnosis score' will be calculated from the diagnosis generated in the electronic medical record (emr). the determined 'total toxicity score' will be correlated with the 'symptoms score' and the 'diagnosis score.' the observations from this study will help us understand the potential effect of environmental toxins, heavy metals, pfas and mycotoxins on gi and overall health.

Eligibility criteria:
inclusion criteria: * patients suffering from gastrointestinal and/or other symptoms * patients willing to provide urine samples * patients willing to provide consent exclusion criteria: * use of antibiotics 2 weeks prior to the study * patients unwilling to consent

Keywords: gastrointestinal symptoms toxins environmental toxins heavy metals pfas mycotoxins
ulinastatin for the treatment of covid-19 in hospitalized patients

Conditions: COVID-19

Summary: the primary objective of this study is to evaluate the safety and efficacy of intravenous (iv) infusion of ulinastatin compared to placebo with respect to time to recovery, disease severity, need for ventilator support, and mortality in patients with covid 19.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * signs and symptoms suggestive of covid-19 infection * laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection ≤7 days before randomization * currently hospitalized or in an emergency department with planned hospitalization * peripheral capillary oxygen saturation (spo2) \<93% on room air at screening exclusion criteria: * simultaneous participation in any other clinical study incompatible with this one * treatment with an antibody immunotherapy within 4 weeks of screening * requirement for mechanical ventilation or ecmo at screening * hypotension at screening * severe liver injury defined as ast or alt ≥5x the upper limit of normal * severe kidney failure defined as an estimated glomerular filtration rate (egfr) \<30 ml/min * pregnancy or breastfeeding * \> 120 hours between admission and signing consent