Kornimate/medical-research-clean huggingface dataset:
high-dose intravenous vitamin c for the treatment of severe acute pancreatitis

Conditions: Severe Acute Pancreatitis

Summary: this study is a prospective, randomized, double-blinded, parallel-controlled, multi-central clinical trial for patients with severe acute pancreatitis (sap). patients with sap in the early stage (within 7 days of onset) and over the age of 18, based on the routine treatment, will be randomly divided into a high-dose intravenous vitamin c group (hdivc, 500mg/kg/24h, administered by iv. pump at a rate of 2g/h for 7 days) and a control group (an equal volume of normal saline). the primary endpoint is mortality rate in icu, and secondary endpoints include free organ support duration (fosd) within 14 days after enrollment, changes in inflammatory response and severity, disease severity scores and changes, fluid retention, incidence of infectious pancreatic necrosis (ipn), icu mortality, pancreatic necrosis scores, monitoring of vitamin c plasma concentrations before and after hdivc use, composition of gut microbiota, observation of vitamin c-related adverse reactions. the study hypothesis is that hdivc can reduce mortality rate in icu, significantly decrease the fosd within 14 days and significantly reduce inflammatory response, decrease fluid retention, and improve disease severity.


Eligibility criteria:
inclusion criteria: * age ≥18 years * time from onset of illness to enrollment is less than 7 days * meet the 2012 atlanta guidelines sap diagnostic criteria exclusion criteria: * sap caused by tumors or ercp * pregnant or breastfeeding * allergic to vitamin c * use of other experimental drugs within the timeframe of this study * chronic organs failure such as heart, liver, lung, or kidney before admission, with specific indicators being (chronic cardiovascular dysfunction requiring long-term mechanical hemodynamic support or inotropic drug support; chronic obstructive pulmonary disease requiring home oxygen therapy; chronic liver dysfunction at child-pugh class c; chronic kidney disease with an estimated glomerular filtration rate (egfr) of less than 60 ml/min/1.73 m² or serum creatinine greater than 150 μmol/l) * immunosuppressed state, including malignant tumors, post-transplant status, long-term use of immunosuppressor (for at least 1 month before enrollment), aids, etc. * the patient and family are unwilling to sign the informed consent form * body weight greater than 100kg * urinary system stones

Keywords: high-dose intravenous vitamin c severe acute pancreatitis
comparison between methyl prednisolone and intravenous dexamethazone in severe immune thrombocytopenic purpra

Conditions: Immune Thrombocytopenia

Summary: immune thrombocytopenic purpra(itp) is an autoimmune thrombocytopenic syndrome characterized by decreased platelet count and increased risk of bleeding, primarily due to immunoglobulins g(igg)autoantibodies opsonizing the individual's platelets,resulting in markedly enhanced fc receptors(fcr)-mediated phagocytosis and destruction by macrophages in the reticuloendothelial system within spleen severe itp defined as :patients who have clinically relevant bleeding that mean that patients have bleeding symptoms at presentation sufficient to mandate treatment,or occurrence of new bleeding symptoms requiring additional therapeutic intervention with a different platelet-enhancing agent or an increased dose.

immune thrombocytopenic purpra(itp) is an autoimmune thrombocytopenic syndrome characterized by decreased platelet count and increased risk of bleeding, primarily due to immunoglobulins g(igg)autoantibodies opsonizing the individual's platelets,resulting in markedly enhanced fc receptors(fcr)-mediated phagocytosis and destruction by macrophages in the reticuloendothelial system within spleen severe itp defined as :patients who have clinically relevant bleeding that mean that patients have bleeding symptoms at presentation sufficient to mandate treatment,or occurrence of new bleeding symptoms requiring additional therapeutic intervention with a different platelet-enhancing agent or an increased dose.prednislone is the standard intial first-line therapy in naïve itp patients.prednislone is usually given at 0.5 to 2mg/kg until platelet count increase(\>30-50 \*10\^9/l )which may require several days to several weeks,however prednisone should be rapidly tapered after 4 weeks to avoid corticosteroid related complication. in a trial to shorten the duration and reduce adverse effects of corticosteroids treatment. dexamethasone in a dose of 40mg/day has been administered for 4days (equivalent to\~400mg of prednisone per day) achieved 85% initial reponse and sustained response 50% of adult cases of itp at 6 months follow up

Eligibility criteria:
inclusion criteria: * patients were aged 18or older diagnosed as acute severe itp presented with active bleeding for emergency treatment. exclusion criteria: * any contraindications for steroid therapy (osteoprosis, uncontrolled diabetes or uncontrolled hypertension).

Keywords: dexamethazone prednislone severe itp
treatment intensity/factors predicting short and long term outcomes in elderly critically ill patients

Conditions: Critically Ill Very Elderly Patients Admitted to ICU's

Summary: 1. patients greater than 90 years of age will have poorer outcomes in terms of mortality than younger patients controlling for disease and acuity 2. patients greater than 90 years old will consume more resources than younger patients controlling for disease and acuity 3. patients greater than 90 years old will show lower levels of function than younger patients controlling for disease and acuity 4. patients greater than 90 years old will show lower levels of hrqol at 90-120 days post icu discharge than younger patients controlling for disease and acuity

elderly patients make up between 26% and 51% of patients who are admitted to icus. the proportion of individuals in north america aged \> 65 is projected to increase to 20% of the population by 2026. as population demographics change, and as new technologies, pharmaceuticals, and interventions prolong lives, the proportion of elderly patients admitted to icus and surviving icu stay will continue to increase. studies that have examined only icu or hospital survival as an outcome have had variable results. few studies have demonstrated that elderly icu patients experience higher mortality rates, while others have demonstrated that age alone, when adjusted for other factors, is not an important prognostic indicator among elderly patients admitted to the intensive care units (icu). however, age is still used as an important criteria for admission to icus. most studies reviewed have looked at patients sixty-five to ninety years old. to our knowledge only two studies to date have addressed this issue among patients older than 90 to an icu, both were retrospective. with increasing age there is a parallel increase in health care costs. the use of expensive technology and procedures in the very elderly is fast becoming a major concern. data on resource allocation and treatment intensity in the (90+) subgroup is sparse. beyond mortality and cost, health-related quality of life (hrqol) is a fundamentally important end point of medical care. few studies have addressed outcomes in terms of hrqol and functional status of elderly following discharge the from critical care unit. these studies were limited by small number of subjects enrolled, retrospective design, and lack of validated tool to assess hrqol. we plan to prospectively collect data to look at determinants of treatment intensity, outcome, and resource allocation in elderly patients ages 65 and above admitted to the icu with care taken to including as many patients in the age interval above 90 years of age. we will also assess hrqol and functional status in very elderly patients who survive admission and are discharged from the hospital.

Eligibility criteria:
inclusion criteria: * patients 65 year an older admitted to micu, sicu, and ccu exclusion criteria: * patients who refuse to complete hrql questionaire while hospitalized * subjects refuse to participate

Keywords: outcome elderly icu quality of life
effect of exercise in oi

Conditions: Orthostatic Intolerance; Postural Tachycardia Syndrome

Summary: the main limitation patients with orthostatic intolerance (oi, or postural tachycardia syndrome, pots) have to exercise is related to their increase in heart rate when standing. main pharmacological treatment today is aimed at reducing heart rate with the use of betablockers (propanolol), this theoretically could also improve their exercise capacity; if their heart rate do not increase as much with the medication, they could exercise more. in addition, it has been suggested that in healthy volunteers subjected to head down tilt for 2 weeks (situation that produces a "simulated" transient pots-like state) a single bout of intense exercise can improve orthostatic tolerance the day after exercising. the mechanisms involved in such response are not that clear but could be an increase in plasma volume already diminished in pots patients. it seems likely that the same could be true for pots patients. the purpose of the present study are to pharmacologically improve the amount of exercise pots patients can perform by reducing their baseline heart rate (specific aim 1) and to evaluate next day heart responses to an acute bout of intense exercise. therefore, the specific aims of this study are: 1. to test the hypothesis that lowering heart rate response with propanolol will result in an increase in exercise capacity. 2. to test the hypothesis that a single bout of exercise will result in an improvement in orthostatic tolerance the day after exercising.

* subjects will be studied twice, once after receiving placebo and in a second occasion after receiving propanolol. * an exercise capacity test with estimation of maximal oxygen consumption (vo2 max) will be done within 1 hour of receiving a pill containing placebo and that will be in appearance identical to the one for propanolol. this test will be conducted on a stationary bicycle and the effort will be gradually increased while expired air is measured during exhaustive physical work. the test will last approximately 30 minutes and be conducted in vanderbilt's clinical trial center. * the day before and the day after the exercise test subjects will be asked to collect urine for 12 hours each time and to keep a record of how much liquid they ingest. * posture study tests (measurements of heart rate and blood pressure taken while lying down and at intervals for up to 30 minutes while standing) will be done the day before and the day after the exercise test.

Eligibility criteria:
inclusion criteria: * meet diagnostic criteria of pots (raj, et al., 2005) * age between 18-65 years * male and female are eligible (although the majority of patients pots are female). * able and willing to provide informed consent exclusion criteria: * presence of medical conditions that can explain postural tachycardia (e.g., dehydration, medications) * pregnancy * other factors which in the investigator's opinion would prevent the subject from completing the protocol. * patients who are bedridden or chair-ridden.

Keywords: exercise propanolol beta blockers
utilizing carbon dioxide for assessing coronary blood flow in subjects with coronary artery disease

Conditions: Coronary Artery Disease

Summary: this is a prospective pilot study to evaluate the safety, tolerability and technical feasibility of utilizing carbon dioxide for assessing coronary blood flow in subjects with coronary artery disease.

the purpose of this study is to noninvasively assess changes in the heart's blood flow through inducing changes in the amount of carbon dioxide in the participant's blood and having them breathe various combinations of carbon dioxide and oxygen.

Eligibility criteria:
inclusion criteria: 1. adults \> 18 years of age 2. clinically stable individuals with suspected or known coronary artery disease (cad) 3. the spect/pet study indicates at least a mild to moderate myocardial ischemia (\>5-9%) or fractional-flow-reserve (ffr) of \<0.75. exclusion criteria: 1. prior myocardial infarction by clinical history (subjects with prior coronary revascularization without myocardial infarction will not be excluded) 2. hypotension (systolic blood pressure \< 100 mmhg) 3. significant non-coronary cardiac disease (e.g., valvular abnormality, or cardiomyopathy, etc.) 4. inability to schedule the research study within 30 days of the spect/pet study and prior to any coronary revascularization procedure 5. inability to voluntarily increase their breathing rate if prompted to do so 6. persons with mechanically, magnetically, or electrically activated implants (such as cardiac pacemakers, neurostimulators, and infusion pumps), with ferromagnetic implants or foreign bodies (such as intracranial, aneurysm clips, shrapnel, and intraocular metal chips) 7. persons who are pregnant, nursing, or implanted with intrauterine devices (iud's) 8. persons with a history of significant heart, lung, kidney, or liver disease 9. persons with asthma 10. persons who have abnormal cardiac rhythm and rate 11. persons unable to tolerate mri secondary to an inability to lie supine for 60-90 minutes or severe claustrophobia 12. persons whose renal function test does not meet mri contrast protocol requirements \[estimated glomerular filtration rate (egfr) \< 40 ml/min/1.73m2\] 13. persons with a known history of allergy to gadolinium-based contrast 14. enrollment in another research study. 15. inability or unwillingness to provide informed consent
higher frequency zoledronic acid in the treatment of multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine whether lower than conventional doses of dexamethasone and thalidomide; and a higher dosing frequency of zoledronic acid are effective in the treatment of newly-diagnosed multiple myeloma.

patients with newly-diagnosed multiple myeloma (mm) may be treated using monthly cycles of dexamethasone plus thalidomide (dt). unfortunately, the use of conventional doses of dt is associated with significant treatment-related morbidity and mortality, which is comparable to that observed with conventional chemotherapy. hence, for safety reasons, patients frequently receive lower than conventional doses of dt (i.e. dt), and potentially experience a poorer anti-mm effect. the highly-potent aminobisphosphonate, zoledronic acid (z), has been shown in pre-clinical mouse models to exhibit an impressive anti-mm effect. it is therefore possible to combined dt with z (i.e. dtz) to enhance the efficacy of (lower dose) dt. in addition, the anti-tumor effect of dtz may potentially be augmented by using z at a higher (three-weekly) dosing frequency.

Eligibility criteria:
inclusion criteria: * age at or above 21 years * clinical diagnosis of mm * active mm with measurable disease * signed written informed consent * signed consent for drug safety program for thalidomide exclusion criteria: * patients with monoclonal gammopathy of undetermined significance (mgus) * patients with indolent mm (imm), or smouldering mm (smm) * known hypersensitivity (including severe cutaneous reactions) to d, t or z * fulminant sepsis * females in the reproductive age group who refuse contraception * pregnancy * 24 hr urinary creatinine clearance time (cct) \<30 ml/min * previous renal transplantation * severe peripheral neuropathy * recurrent dvt or pe * severe arrhythmias and cardiac conduction disorders * liver dysfunction of active viral hepatitis * osteonecrosis of the jaws (onj)

Keywords: steroids, fluorinated thalidomide bisphosphonates
combination margetuximab and pembrolizumab for advanced, metastatic her2(+) gastric or gastroesophageal junction cancer

Conditions: Gastric Cancer; Stomach Cancer; Esophageal Cancer

Summary: this main purpose of this clinical study is to learn about the safety and activity of margetuximab and pembrolizumab combination treatment in patients with her2+ gastric and gastroesophageal junction cancer.

detailed description: both margetuximab and pembrolizumab are monoclonal antibodies used in combination to treat her2+ gastric and gastroesophageal junction cancer. this study has two parts: dose escalation and dose expansion. the dose escalation phase of the study will evaluate safety of escalating doses of the combination treatment. the dose expansion phase will evaluate safety and activity of the combination in patients with gastric or gastroesophageal cancer once the final dose and schedule are defined. in addition, a cohort of patients with her2+ 3+ gastric cancer patients will be enrolled in the dose expansion phase.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. age ≥ 18 years old (or minimum age based upon local regulations) 3. unresectable locally advanced or metastatic histologically proven her2+ gastroesophageal junction (gej) or gastric cancer. gastric cancer expansion phase will include only gastric cancer patients with 3+ her2 positivity. 4. her2+ as 3+ (as defined in ajcc staging manual 8th edition) by ihc or in-situ hybridation (ish) amplified. 5. have received prior treatment with trastuzumab. 6. have received treatment with at least one or more lines of cytotoxic chemotherapy in the metastatic setting. 7. resolution of chemotherapy, immunotherapy or radiation-related toxicities. 8. eastern cooperative oncology group (ecog) performance status of 0 or 1. 9. life expectancy ≥ 12 weeks. 10. measurable disease as per recist 1.1 criteria. exclusion criteria: 1. patients with symptomatic central nervous system (cns) metastases. 2. patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment. 3. history of prior allogeneic bone marrow, stem-cell or solid organ transplantation. 4. treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 3 weeks prior to the initiation of study drug. 5. treatment with radiation therapy within 3 weeks prior to the initiation of study drug administration. 6. treatment with corticosteroids (≥10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration. 7. history of clinically-significant cardiovascular disease. 8. clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation. 9. history of (non-infectious) pneumonitis that required steroids or presence of active pneumonitis 10. clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis. 11. evidence of active viral, bacterial, or systemic fungal infection.
safety and efficacy of sofwave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow

Conditions: Skin Laxity; Wrinkle; Brow Lifting

Summary: this is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of sofwave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.

this is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of sofwave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow. up to 112 healthy candidates who are seeking treatment from participating investigators will be enrolled at up to 5 participating study sites. patients will receive 2 treatments (4-6 weeks ± 2 weeks apart) with the sofwave system and will be followed up to 3 months post the last treatment (fu2).

Eligibility criteria:
inclusion criteria: 1. healthy female and male subjects between the ages 35-80. 2. non-smoker. 3. fitzpatrick skin type i-vi. 4. desire to lift lax skin in the neck and submental and/or to lift the brows. 5. able and willing to comply with all visit, treatment and evaluation schedules and requirements. 6. able to understand and provide written informed consent 7. women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment. exclusion criteria: 1. pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding. 2. presence of any active systemic or local infections. 3. presence of active local skin disease that may alter wound healing. 4. severe solar elastosis. 5. history of epileptic seizures. 6. history of severe migraine tendency. 7. history of smoking in past 10 years. 8. history of chronic drug or alcohol abuse. 9. excessive subcutaneous fat on the cheeks. 10. significant scarring in the area to be treated. 11. severe or cystic facial acne, acutance uses during past 6 months. 12. presence of a metal stent or implant in the facial area. 13. inability to understand the protocol or to give informed consent. 14. on-going use of psychiatric medication. 15. history of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past year; injectable filler of any type within the past year; botox or fillers in the lower face within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months. 16. taking isotretinoin or other oral retinoid within the past 6 months; taking psychiatric drugs, anti-platelet or anti-coagulant within the past 2 weeks. 17. as per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study. -

Keywords: skin laxity submental neck brow lifting laxity saggy