Kornimate/medical-research-clean huggingface dataset:
a safety extension study to evaluate the long-term safety of qge031 in chronic spontaneous urticaria (csu) patients

Conditions: Chronic Spontaneous Urticaria

Summary: a safety extension study to evaluate the long-term safety of qge031 240 mg s.c. given every 4 weeks for 52 weeks in chronic spontaneous urticaria (csu) patients who completed study cqge031c2201

a safety extension study to evaluate the long-term safety of qge031 in chronic spontaneous urticaria patients

Eligibility criteria:
inclusion criteria: * patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. written informed consent must be obtained before any assessment is performed. 2. patients who complete the treatment epoch in study cqge031c2201 and complete at least visit 203 (week 32 of the follow-up epoch, ≥16 weeks after last injection) and present with active disease as defined by uas7 ≥12. 3. patients must not have any missing ediary entries in the 7 days prior to visit 301 (patients are allowed to repeat until this criterion is met). 4. willing and able to complete a daily symptom ediary for the duration of the study and adhere to the study visit schedules. exclusion criteria: clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria * evidence of parasitic infection * any other skin diseases than chronic spontaneous urticaria with chronic itching * contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine * history of anaphylaxis * history or current diagnosis of ecg abnormalities indicating significant risk of safety for patients participating in the study * history of hypersensitivity to any of the study drugs or its components of similar chemical classes * pregnant or nursing (lactating) women other protocol-defined inclusion/exclusion criteria may apply

Keywords: qge031 chronic spontaneous urticaria csu adults safety ligelizumab
metabolomic and epigenetic profiling of bodyfluids from lung and brain cancer receiving radiation therapy

Conditions: Adult Brain Tumor; Lung Cancer; Radiation Toxicity

Summary: this research trial studies metabolomic and other molecular profiling to identify predictive biomarkers for radiation toxicity and survival in patients with lung or brain cancers receiving radiation therapy. studying samples of blood, urine, and tissue from patients with lung or brain cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict which patients are at higher risk for developing radiation side effects and how well patients will respond to radiation treatment.

primary objectives: i. metabolomic and epigenetic urine and blood profiles of patients undergoing radiation therapy for lung cancer associated with the development of radiation pneumonitis. ii. metabolomic and epigenetic urine and blood profiles of patients undergoing radiation therapy for brain cancer associated with the development of radiation necrosis. secondary objectives: i. metabolomic and epigenetic urine, blood, and tissue profiles of patients undergoing radiation therapy for lung and brain cancer associated with survival. outline: collected blood, urine, and tissue samples are analyzed for biomarkers via metabolomic and epigenetic profiling using mass spectrometry, array, and sequencing-based technology.

Eligibility criteria:
inclusion criteria: * consultation with the radiation oncology department of the ohio state university (osu) comprehensive cancer center * the following diagnoses will be included: malignant neoplasm of the brain; primary malignant neoplasm of trachea bronchus and lung; primary malignant neoplasm of the cervix uteri and primary malignant neoplasm the prostate exclusion criteria: * being an inmate

Keywords: biomarker radiation
a study on the effects of nutritious mushrooms in adults with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: obesity, characterized by an increase in body weight that results in excessive fat accumulation, is a global health problem. recently, it has also been shown that obesity is associated with low-grade chronic systemic inflammation in adipose tissue. this condition is mediated by activation of the innate immune system in adipose tissue that promotes inflammation and oxidative stress and triggers a systemic acute-phase response. previous research points towards the potential of phytochemicals in food as part of nutritional strategies for the prevention of obesity and associated inflammation, as well as, increase in insulin sensitivity in diabetic patients. in addition, there is strong evidence that obesity is inversely associated with vitamin d levels. the major cause of vitamin d deficiency in humans is the lack of adequate sun exposure. unfortunately, very few foods, i.e. mushrooms, naturally contain vitamin d and foods that are fortified with vitamin d are inadequate to satisfy vitamin d requirements. the last decade, mushrooms have attracted the research interest as functional foods with desirable health benefits in several metabolic disorders without the side effects of pharmacological treatment. edible mushrooms are highly nutritious and exhibit beneficial effects on several inflammatory diseases such as cancer, heart disease, diabetes,, high blood pressure. thus, the purpose of this study is to determine the effects of nutritious mushrooms in adults with metabolic syndrome. more specifically, 100 participants will be allocated to two groups, namely intervention group (n=50) and control group (n=50). vitamin d2-enhanced mushrooms by uv-b will be provided as a snack to the intervention group, whereas the control group will not consume the snack. the intervention will last 3 months.the effects of the intervention will be evaluated via clinical and laboratory markers. personal and family history, anthropometric, demographic data, body composition, dietary habits, physical activity and smoking status will be assessed pre- and post- intervention. biochemical profile, oxidative stress and inflammation, as well as metabolomic profiles will be assessed in blood samples pre- and post- intervention. both groups will receive standard nutritional counselling throughout the intervention and will be encouraged to report any adverse effects they may experience during the intervention.


Eligibility criteria:
inclusion criteria: * 30 years \< age \< 65 years * bmi \> 25 kg/ m2 * metabolic syndrome exclusion criteria: * hepatotoxic medication * diabetes mellitus * dysthyroidism, hypopituitarism, cushing syndrome / disease * pregnancy, lactation * psychiatric or mental disorder * any use of antioxidant-phytochemical rich supplement, vitamin d supplement, nti-, pre- or pro-biotics within 3 months pre-intervention
effectiveness of dn and stm combined with self-stretching for management of calf and heel pain

Conditions: Heel Pain Syndrome

Summary: to determine the effectiveness of dry needling and soft tissue mobilization with self-stretching for the management of calf and heel pain. in our topic pain and physical dysfunction are our variables


Eligibility criteria:
inclusion criteria: * patients will be between the ages of 25 to 60 years. * female and males. * history of heel and calf pain. * pain level moderate . * trigger point / inactive trigger points. * acute stage patients. exclusion criteria: * phobias like injections or needles. * unwilling patients * patients on anticoagulant medicines. * patients with ra * fibromyalgia syndrome. * pateint with recent trauma and surgery.
physiotherapy in acute exacerbation of chronic obstructive pulmonary disease

Conditions: COPD

Summary: chronic obstructive pulmonary disease (copd) is projected to be the fifth leading burden of disease worldwide by the year 2020. an acute exacerbation of copd (aecopd) is defined as an acute event characterized by a worsening of the patient's respiratory symptoms that requires a modification in the medication. aecopd are frequent (mean of 1-4 exacerbations each year). it increases in frequency with the severity of the disease. the objective of this study is to examine whether a physical therapy intervention can reduce impairment in patients with copd during hospitalization due to an acute exacerbation.

chronic obstructive pulmonary disease (copd) is one of the leading diseases causing mortality and morbidity, despite advanced pharmacotherapy and therapeutic management. copd patients suffer frequent exacerbations, defined as 'acute events characterized by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication'. acute illness and prolonged bed rest are associated with loss of muscle mass and a significant decline in functional ability and mobility. interventions to counteract these impairments are indicated.

Eligibility criteria:
inclusion criteria: * copd diagnosis with exacerbation. * no contraindication of physiotherapy. * signed written consent. * medical approval for inclusion exclusion criteria: * neurological, orthopedic or heart diseases. * prosthetic devices in the lower limbs.

Keywords: copd exacerbation hospitalisation physiotherapy
an investigation on the effects of icosapent ethyl (vascepatm) on inflammatory biomarkers in individuals with covid-19

Conditions: COVID-19; Inflammatory Response

Summary: this is a 14-day long prospective, multi-site, two-armed, randomized, open-label study that will enroll approximately 100 adult outpatients in canada who have received a positive sars-cov-2 test result within the preceding 72 hours. participants will be randomized (1:1) to receive either icosapent ethyl (4 g bid for 3 days, then 2 g bid for the subsequent 11 days) or usual care. blood samples will be collected to determine if icosapent ethyl use lowers circulating pro-inflammatory biomarkers.


Eligibility criteria:
inclusion criteria: 1. positive local sars-cov-2 test result within the preceding 72 hours 2. at least one of the following symptoms 1. fever 2. cough 3. sore throat 4. shortness of breath 5. myalgia exclusion criteria: 1. individuals currently participating in another interventional trial that will or may interfere with the primary outcome 2. hospitalized individuals 3. individuals who have a current medical condition for which life expectancy is less than 3 months 4. individuals with a history of acute end-organ injury (e.g. myocardial infarction, stroke, hospitalization for acute lung, liver or kidney disease) within the last month 5. individuals with active severe liver disease 6. individuals with a history of acute or chronic pancreatitis 7. women who are pregnant, may be pregnant, are planning on becoming pregnant, or are lactating 8. women of child-bearing potential who are not using at least one form of highly effective (hormonal contraceptives \[e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants\]; intrauterine device or intrauterine system; tubal ligation or whose partner has had a vasectomy) and one effective (barrier methods such male condom, female condom, cervical cap, diaphragm, or contraceptive sponge) method of contraception 9. individuals with a history of hemodynamic instability within past 72 hours including a systolic blood pressure of \<95 mmhg and/or a diastolic blood pressure of \<50 mmhg 10. individuals with known hypersensitivity to fish and/or shellfish, or ingredients of ipe 11. individuals with any other condition which, in the opinion of the investigator, would place the participant at increased risk, preclude obtaining voluntary consent or confound the objectives of study 12. individuals who are unable to swallow ipe capsules whole
validation of machine learning based personalized nutrition algorithm to reduce postprandial glycemic excursions among north american individuals with newly diagnosed type 2 diabetes

Conditions: Type2 Diabetes

Summary: this is an initial validation study of the personal nutrition project (pnp) algorithm in a north american population with recently diagnosed type 2 diabetes (t2d). this is a 2-stage, single-group feeding study in 20 individuals, including 10 participants managed with lifestyle alone, and 10 managed with lifestyle plus metformin.

the pnp algorithm, which uses a machine learning algorithm to predict postprandial glycemic, may be efficacious for generating tailored dietary advice to moderate the participant's glycemic response to food.

Eligibility criteria:
inclusion criteria: * age \>21 years to \<70 years * diagnosed with t2dm within 2 years with an hba1c\<7% * diabetes management by metformin or lifestyle intervention * fasting c-peptide ≥ 0.5 mg/ml (0.17 nmol/l) (to exclude those for whom hyperglycemic exposure is driven by β-cell failure rather than dietary behaviors, as well as those requiring escalation of the medication regime) * ownership a smart phone and are willing to use it to monitor multiple factors influencing glycemic response to glycemia (e.g., sleep, physical activity, diet, stress, medication, and hunger) exclusion criteria: * are unable or unwilling to provide informed consent; * are unable to participate meaningfully in an intervention that involves self-monitoring using software available in english (e.g., due to uncorrected sight impairment, illiterate, non-english-speaking, dementia); * are pregnant, are currently trying to become pregnant, or who become pregnant during the study * are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management) * have had or are planning to have bariatric surgery during the study * have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed t2d) * those with an active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study; * those who use acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects cgm accuracy)39 * immunosuppressive drugs within three months prior to participation and * chronically active inflammatory or neoplastic disease in the three years prior to enrollment. * patients with known food allergy.

Keywords: type 2 diabetes hyperglycemia personal nutrition project
carbohydrates under target for type 1 diabetes management

Conditions: Type 1 Diabetes

Summary: recently there has been an increased interest in limiting intake of carbohydrates (cho) for improving long term health. while healthcare professionals (hcps) are sometimes reluctant to limit the cho intake due to the lack of information related to safety issues, low cho diets are increasing in popularity amongst both people with and without diabetes. one of these diets, the very low cho high fat diet (vlchf) raises concern on its impact on the lipid profile, liver, response to glucagon, and insulin dose adjustments when adopting it in the context of type 1 diabetes (t1d). the investigators recently conducted a series of interviews with people with diabetes following a vlchf diet (brazeau et al. manuscript in preparation) to inquire on their reasons for adopting vlchf as well as challenges they faced. the main reasons to initiate the diet were to limit blood glucose fluctuations and reduce medication. an issue that was frequently mentioned during the interviews was the lack of support from hcps which often leads to not discussing it with said hcp. this is an important source of concern that can lead to additional safety issues. our goal is to provide information regarding the safety of a vlchf diet for t1d and the individualized insulin adjustments required. the investigators aim to evaluate the changes in daily blood glucose fluctuations after 6 weeks of a vlchf diet, to monitor the changes in the insulin dosing and to measure impact on lipid profiles, response to glucagon, and liver function.


Eligibility criteria:
inclusion criteria: * duration of type 1 diabetes \> 12 months * on intensive insulin therapy for \> 6 months * own a smartphone or tablet to use two mobile applications : keenoa and piezo: achieve the guidelines! exclusion criteria: * known gastroparesis (clinical diagnosis) * advanced kidney disease (egfr \< 50 ml/min) * known significant liver disease (e.g., cirrhosis, active hepatitis, liver transplantation) * recent (\< 6 months) major cardiovascular even (e.g. myocardial infarction, cerebrovascular accident, major revascularization, etc.) * pregnancy (ongoing or planned in the next 6 months) * breastfeeding * severe hypoglycemia episodes or ketoacidosis in the 4 weeks prior to recruitment * claustrophobia or presence of metal devices/implants in the body
influence positive end-expiratory pressure on autoregulation in patients with respiratory insufficiency

Conditions: Respiratory Insufficiency

Summary: the aim of the present study is to characterize the influence of an elevated positive end-expiratory pressure in patients with acute respiratory distress syndrome or acute lung injury on the cerebrovascular autoregulation.

cerebral blood flow velocity will be measured using transcranial doppler sonography and then correlate with the invasive arterial blood pressure curve to calculate the index of cerebrovascular autoregulation mx (mx\>0.3 indicates impaired ar). the index of cerebrovascular autoregulation mx was measured during baseline positive end-expiratory pressure (peep) levels and after lung recruitment with higher level of peep. the equality between this two peep levels was estimated and calculated with one side wilcoxon test.

Eligibility criteria:
inclusion criteria: * respiratory failure * age \>18 years * invasive ventilation exclusion criteria: * sepsis * preexisting cerebral illness * traumatic brain injury * meningitis or encephalitis * pregnancy

Keywords: acute respiratory distress syndrome acute lung injury cerebrovascular autoregulation transcranial doppler ventilation
outcomes in minimally invasive versus open pancreaticoduodenectomy

Conditions: Pancreatic Disease

Summary: the purpose of this study is to evaluate the impact of the quality of life in patients undergoing the whipple procedure (pancreaticoduodenectomy, pd) for pancreatic cancer. the whipple procedure can be done by laparoscopic (small incisions) or an open procedure (large incision) to treat the patients cancer. the goal of this study is to see if there is any difference in quality of life between patients who undergo the laparoscopic or the open whipple procedure. surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. patients will not be randomized to a treatment arm. a subset of these patients will also be asked to take part in a pre- and postoperative in-depth interview to explore the lived experiences of patients with resectable pancreatic cancer.


Eligibility criteria:
inclusion criteria: * all patients scheduled for pancreaticoduodenectomy will be eligible for this study. * subject must be at least 18 years of age and at least the minimum age of majority according to applicable state or country law. * subject is a suitable surgical candidate, i.e. is able to undergo general anesthesia and pd for diagnosis of cancer * subject is willing and able to cooperate with survey participation. * subject has been informed of the study procedures and the treatment and has signed an informed consent form exclusion criteria: • subject is not a suitable candidate for pd

Keywords: pancreaticoduodenectomy whipple
minimally invasive surgery for ponto bone anchored hearing implants

Conditions: Conductive Hearing Loss; Unilateral Partial Deafness; Mixed Conductive-sensorineural Hearing Loss

Summary: the objective of this study is to make a comparison between two surgical techniques used when implanting a ponto bone anchored hearing system.


Eligibility criteria:
inclusion criteria: * adult patient, i.e. ≥ 18 years of age * eligible for the ponto system exclusion criteria: * known history of immunosuppressive disease * use of systemic immunosuppressive medication * receiving bilateral bone anchored hearing system * relevant dermatological diseases as judged by the investigator * not being able to finish the study, for example because of failure to complete the questionnaires * participating in another study with medical aids or medication * when there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.
the retrieve study: use of the fibernet® embolic protection system in saphenous vein grafts

Conditions: Saphenous Vein Graft Disease; Myocardial Ischemia; Embolism

Summary: this is a multicenter, prospective study designed to demonstrate the performance and safety of the fibernet embolic protection system when used as an adjunctive device during saphenous vein graft (svg) intervention.

the study will involve up to 30 patients to be enrolled using the fibernet device during clinically indicated percutaneous intervention of svg and followed through 30 days post procedure. patients will be enrolled at up to 10 investigative sites. the study is a prospective multi-center registry with sequential enrollment of qualified patients who consent to participate and meet all entrance criteria. the lumen biomedical, inc. fibernet® embolic protection system is indicated for use as a guide wire and embolic protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in saphenous vein grafts with reference vessel diameters of 1.75 mm to 7.0 mm.

Eligibility criteria:
inclusion criteria: * candidate for percutaneous transluminal coronary angioplasty (ptca), stenting and emergent coronary artery bypass graft (cabg). * myocardial ischemia as evidenced by one or more of the following: * diagnosis of stable or unstable angina pectoris * ecg changes consistent with ischemia * positive functional study * recent myocardial infarction * lesion(s) is located within svg and is ≥ 50% and \< 100% stenosed. exclusion criteria: clinical criteria: * myocardial infarction with documented total ck-mb \> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction. * undergone cardiac surgery within the past 60 days. * a planned invasive surgical procedure within 30 days. * the lesion(s) is in an svg that is less than 2 months post-implant. * left ventricular ejection fraction \< 20%. * a stroke or transient ischemic neurological attack (tia) within the past 2 months. angiographic criteria: * the lesion(s) is in an arterial conduit. * lesion is within 10 mm of the proximal anastomosis. * more than two native lesions \[in addition to the svg lesion(s)\] that need to be treated at the index procedure. * more than two svgs that need to be treated at the index procedure. * chronic total occlusion of a target lesion. * the svg lesion(s) requires treatment with a large device other than ptca prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, rheolytic thrombectomy or brachytherapy).

Keywords: svg saphenous vein graft embolic protection distal protection epd fibernet saphenous vein graft intervention