Kornimate/medical-research-clean huggingface dataset:
a study of mavrilimumab in subjects with moderate-to-severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (mtx) in subjects with moderate-to-severe adult onset rheumatoid arthritis (ra).

despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis, there is still significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. the aim of the study is to explore the optimum dose of mavrilimumab for further clinical development and more fully investigate the efficacy and safety profile of mavrilimumab after longer drug exposure (that is, 24 weeks). the results of this study will form the basis for future clinical studies with mavrilimumab.

Eligibility criteria:
inclusion criteria: * a diagnosis of adult onset rheumatoid arthritis (ra) in line with the protocol * moderately active disease in line with the protocol * a pre-defined number of swollen joints in line with the protocol * inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (dmards) * no evidence of respiratory disease. exclusion criteria: * a rheumatic autoimmune disease other than ra, or significant systemic extra-articular involvement secondary to ra * a history of, or current, inflammatory joint disease other than ra * previous treatment with the investigational drug * discontinuation of a biologic dmard due to lack of efficacy * non-compliant concurrent medications * non-compliance with medical history criteria.

Keywords: rheumatoid arthritis mavrilimumab cam-3001
effectiveness of nurse-led physical therapy in terms of patient competency, patient engagement and physical performance.

Conditions: Chronic Liver Disease and Cirrhosis

Summary: due to prolonged diseased condition, patients are not able to care for themselves and even avoid movement their range of motion is limited which may develop frailty among liver disease patients. this study aims at assessing engagement, competency and physical performance of physical frail chronic liver disease patients before and after nurse led physical therapy. besides these parameters effect of intervention on physical frailty will also be assessed.

research approach: quantitative study research design: quasi experimental research design ( pre-test - post test control group design) setting: study is planned on opd patients of ilbs, new delhi. sampling technique: random allocation in experiment and control group after matching for age and gender sample size: 80 patients variables: independent variable- nurse-led physical therapy dependent variable- patient competency, patient engagement, physical performance.

Eligibility criteria:
inclusion criteria: * prefrail and frail cld patients (meld \<24) * follow up of prefrail and frail cld patients (meld\<24) * participants willing for research exclusion criteria: * frail patients who are bedridden * presence of hepatopulmonary disease * presence of neurological defects * previous history of liver transplantation * severe copd, heart failure

Keywords: patient competency patient engagement physical performance cld meld
thermic effect of three different meals in healthy women

Conditions: Weight Loss; Obesity

Summary: this study will investigate the acute effect of three isocaloric meals varying in level of food processing, including a whole foods, gluten-free, and highly processed meal on energy metabolism and blood glucose in 8-12 young adult, normal weight females. a secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals.

a shift towards a diet containing large quantities of highly processed foods is believed to be a major contributor to the trends in obesity. the degree of processing of foods often affects the nutritional content of the constituents. a reduction in macromolecular complexity allows for an increased rate of digestion, meaning that the body does not have to work as hard to metabolize high processed food products. thus, the purpose of this study is to investigate the effect on energy metabolism and blood glucose after the consumption of an unrefined, whole foods meal versus two highly processed food meals, including a common western style meal and gluten-free meal in 8-12 young adult, normal weight females. a secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals. it is hypothesized that an unrefined meal will induce a greater postprandial thermogenic response and a smaller blood glucose response than a highly processed or gluten-free meal. additionally, it is hypothesized that a highly processed foods meal will be considered more palatable than an unrefined or gluten-free meal.

Eligibility criteria:
inclusion criteria: * healthy females between the ages of 18 and 24 years that have bmis that fall in the range of 18.5 kg/m2 to 28 kg/m2. exclusion criteria: * those with a history of celiac disease or other food allergies, metabolic disease or heart disease.
sequential ehr based interventions to increase genetic testing for breast and ovarian cancer predisposition

Conditions: Genetic Predisposition to Disease; Breast Cancer Female; Ovarian Cancer; Hereditary Breast and Ovarian Cancer; Hereditary Cancer Syndrome; Hereditary Diseases; Gene Mutation-Related Cancer

Summary: the goal of this sequential study design is to increase genetic testing in those meeting national clinical guidelines. the main question it aims to answer is: which intervention is most effective in uptake of genetic testing for the target population? participants will receive genetic testing and counseling that may initiate life-saving screenings.

germline genetic testing is recommended by the national cancer center network (nccn) for individuals with a personal history of ovarian cancer, young-onset (\<50 years) breast cancer, and a family history of ovarian cancer or male breast cancer, among others. recent publications demonstrate that the uptake of genetic testing is under-utilized, overall, and rates are consistently lower in minority populations. ehr-based algorithms will be used to identify patients of two penn medicine ob/gyn practices for whom genetic testing is recommended based on nccn guidelines and to test pragmatic methods using messages delivered to patients or clinicians to encourage testing. the acc electronic phenotyping core developed the algorithms based on cancer registry data along with family history fields and this study will develop and test messages directed at patients and clinicians to encourage testing. the aims are: 1. identification of at-risk populations through electronic health record (ehr) searches followed by patient nudges (mpm and then way to health) to increase the uptake of genetic counseling referral and testing in patients at gynecology practices at dickens center and penn medicine radnor. 2. in patients who have not responded to patient nudges (aim 1), test a provider nudge to increase the uptake of genetic counseling referral and testing in gynecology practices at dickens center and penn medicine radnor (aim 2).

Eligibility criteria:
inclusion criteria: 1. patients with serous ovarian cancer diagnosed more than two years prior to study contact 2. patients with breast cancer diagnosed at \<50 years of age more than two years prior to study contact 3. patients with triple negative breast cancer diagnosed more than two years prior to study contact 4. unaffected individuals reporting a family history of ovarian cancer 5. unaffected individuals reporting a family history of male breast cancer 6. unaffected individuals reporting a family history of breast cancer \<50 years exclusion criteria: 1. patients who have previously received genetic counseling and/or testing

Keywords: nccn guidelines genetic testing hereditary cancer breast cancer ovarian cancer intervention sequential intervention message-based intervention text message diverse patient population genetics female digital health technology germline genetic testing nudge ehr based intervention genetic counseling
evaluation of metformin activity in addition to conventional treatment of grade ii or iii pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension

Summary: treatment of pah includes exercise limitation, non specific agents (anticoagulants, diuretics and supplemental oxygen), pulmonary specific vasodilators and antiproliferative agents. recent data obtained by our group, within rat pah models, showed that the antihyperglycemic drug metformin, used in france since 1959 in diabetic type ii patients, significantly acts at the pulmonary arteries level. according to these results, and knowing that metformin is a widely used drug, with a favorable safety profile, the investigators decided to set up a pilot study, in order to evaluate the activity of metformin in pah treatment. in parallel, the investigators will focus on metformin mechanism of action.


Eligibility criteria:
inclusion criteria: * men or women aged between 18 and 80 * patients included will have pre-capillary pah * they have to be stable for more than 3 months * patient with a 6-minute walk test comparable over the last 3 months before inclusion * informed consent signed
effects of enteral nutrition content on disease progression in sepsis patients

Conditions: Sepsis; Nutritional Deficiency

Summary: the aim of this study was to investigate the effects of enteral nutrition content on disease progression in sepsis patients.

sepsis is a serious health problem with high mortality and morbidity rates worldwide. over-activation of the inflammatory response and related organ dysfunctions are the main characteristics of sepsis. rapid diagnosis and effective management are of vital importance in the treatment of sepsis. in this context, the role of enteral nutrition in the progression of the disease is increasingly being investigated. enteral nutrition is the practice of providing nutrients through the gastrointestinal tract and is a preferred method compared to parenteral nutrition in critical illnesses, especially in sepsis. the enteral route may reduce the risk of microbial translocation and modulate the immune system by maintaining intestinal integrity. therefore, the content of enteral nutrition in sepsis patients may significantly affect the course of the disease. existing literature examines the effects of different enteral nutrient contents on patients with sepsis, with a particular focus on how macro- and micronutrient compositions can modulate inflammatory and immune responses. this study aims to examine the effects of enteral nutritional content on disease progression in patients with sepsis. this prospective cross-sectional study will be conducted with patients diagnosed with sepsis being treated in the intensive care unit of mehmet akif inan training and research hospital. the study was planned to evaluate the effect of energy and nutrient intake on disease outcomes. within the scope of the study, 60 patients diagnosed with sepsis will be followed up according to treatment in intensive care unit. the inclusion criteria of the study include being diagnosed with sepsis and being 24 hours after the start of treatment in the intensive care unit and being able to receive enteral nutrition. exclusion criteria included having chronic liver disease, chronic renal failure, active cancer disease and being on parenteral nutrition. data collection general and health information of the participants will be obtained from the patient file. nutritional information of the participants will be calculated by the researcher by noting the amount of food and formula taken with enteral nutrition for 7 days and 7-day food consumption will be calculated. biochemical and inflammatory data including glucose, albumin, crp, haemoglobin, urea, creatinine, lymphocytes, leukocytes, monocytes, neutrophils, eosinophils, basophils will be obtained from the patient records at the beginning of the study and after 7 days.

Eligibility criteria:
inclusion criteria: * being diagnosed with sepsis and being able to receive enteral nutrition 24 hours after starting treatment in the intensive care unit exclusion criteria: * chronic liver disease, chronic renal failure, active cancer or parenteral nutrition

Keywords: sepsis intensive care nutrition
specific immunotherapy with recombinant birch pollen allergen rbet v1-fv

Conditions: Birch Pollen Allergy

Summary: specific immunotherapy with recombinant birch pollen allergen rbet v1-fv


Eligibility criteria:
inclusion criteria: * positive rast result to birch pollen * positive skin prick test reaction to birch pollen * positive nasal provocation test result to birch pollen extract exclusion criteria: * serious chronic diseases * other relevant seasonal allergies

Keywords: allergy birch pollen recombinant
acute optimization of cardiac resynchronization therapy (crt)using echocardiography and sonr

Conditions: Heart Failure

Summary: the purpose of this study is to correlate the three lead placement (wires that go to the heart) possibilities and the responses from the patient's heart. this will be done with the help of an echocardiography and sonr signals, which is an external device that is capable of detecting sounds created by the heart.

a cardiac resynchronization therapy defibrillator (crt-d) is a device designed to automatically recognize and stop rapid, harmful heart beats and allow the heart to return to a safe, regular heart rhythm. the crt-d device may help the heart pump more efficiently by improving the timing of different parts of the heart beat. a crt-d device has three leads (wires that go to the heart). one lead is placed in one of the top chambers of the heart (right atrium), another lead is placed in the lower right chamber (right ventricle) and the third lead is placed along the side of the left ventricle. the top chambers are stimulated first, either by the natural heartbeat or by the crt-d device if the heartbeat is too slow. shortly after that, the bottom chambers are stimulated. by pacing the heart in this way, the doctor hopes to improve the timing of different components of the heart beat in order to improve the efficiency of the heart and to improve the patient's heart failure symptoms. the purpose of this study is to correlate the three lead placement possibilities and the responses from the patient's heart. this will be done with the help of an echocardiography and sonr signals, which is an external device that is capable of detecting sounds created by the heart. based on the crt implant, special measurements will be made to optimize the placements of the device leads. based on the success of those measurements and a patient's own response, the patient will be placed into one of three groups. group 1: patients with no response patients with a successful response will be randomized to: group 2: lead placement based on study measurements or group 3: standard lead placement

Eligibility criteria:
inclusion criteria: * must have been indicated for implantation or upgrade to a crt-d system in the last 3 months * indicated for crt according to current guidelines * qrs duration between 120 ms and 150 ms * able and willing to provide consent and authorization of use of phi exclusion criteria: * myocardial infarction or acute coronary syndrome deemed inappropriate for trial per the investigator within 90 days of implant * planned, or recent heart surgery or revascularization within the last three months * already enrolled in other study that precludes enrollment in this study per principal investigator * known pregnancy at the time of enrollment * age less than 18 at the time of enrollment * unable to comply with follow-up requirements * chronic atrial fibrillation * recent history of medical non-compliance as determined by the investigator * unable or unwilling to provide consent and authorization of use of phi

Keywords: heart failure echocardiography
melatonin and cardiac outcome after major surgery

Conditions: Aortic Aneurysm

Summary: the purpose of this study is to assess whether treatment with melatonin can reduce cell damage and inflammatory stress response and thereby occurrence of myocardial injury after abdominal aortic surgery.

abdominal aortic surgery is associated with a significant increase of oxidative and inflammatory stress response. aortic surgery is also associated with elevated troponin which is a sensitive and specific marker for myocardial injury. the severity of oxidative stress is correlated with elevated troponin. melatonin, which is a hormone produced in brain, seems to modify cell damage and inflammation. on the other hand we know, that melatonin production first night after surgery is disturbed. the purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation, and thereby occurrence of myocardial injury associated with abdominal aortic surgery.

Eligibility criteria:
inclusion criteria: * indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation * patients between 18 and 80 years old exclusion criteria: * patients with asa class \> 3 * anticoagulation therapy (marevan and marcoumar) * preoperative therapy with opioid, anxiolytic and hypnotic medication * renal insufficient (preoperative creatinin \> 200 mmol/l) * well-known liver insufficient * alcohol consumption (more than 5 drinks) * compliance (language difficulty, mental problems etc.) * pregnancy and breast-feeding * lack of written consent

Keywords: cardiac morbidity melatonin surgery postoperative
diagnosis of lynch syndrome based on next-generation sequencing in colorectal cancer

Conditions: Lynch Syndrome

Summary: the purpose of this study is to determine the proportion of patients diagnosed with lynch syndrome in colorectal cancer patients with the loss of staining by immunohistochemistry (ihc) of any of the mismatch repair (mmr) proteins. besides, this study aims to test the specificity and the sensitivity of detecting microsatellite instability (msi) by next-generation sequencing, and to find out the consistency between ihc and msi in colorectal cancer patients in china. in addition, researchers want to analyze the clinical characteristics and germline mutation of lynch syndrome in chinese population.

1. detect microsatellite instability (by next-generation sequencing and pcr capillary electrophoresis) and germline mutation (by next-generation sequencing) in probands. 2. analyze the test outcome with clinical and family information to evaluate the germline mutation status preliminarily: likely pathogenic germline mutation, variant of uncertain significance, non-pathogenic germline mutation. 3. verify the germline mutation in blood relatives whose proband has known likely pathogenic germline mutation or variant of uncertain significance. 4. diagnose pathogenic germline mutation and non-pathogenic germline mutation based on clinical characteristics, family information and germline mutation test outcomes (including the outcomes of probands and blood relatives). diagnose lynch syndrome and the pathogenic germline mutation carriers in the included population. 5. analyze the specificity and the sensitivity of detecting microsatellite instability (msi) by next-generation sequencing; and analyze the consistency between ihc and msi. 6. analyze the clinical characteristics and germline mutation of lynch syndrome in chinese population.

Eligibility criteria:
for probands, the inclusion criteria: all of the following four points should be satisfied: * histological diagnosis of colorectal cancer; * with the loss of staining by immunohistochemistry of any of the mismatch repair (mmr) proteins (mlh1, msh2, msh6, pms2); * with sufficient tumor tissue and normal tissue to test; * agree to provide basic information, clinical information and family history of cancer information. for probands, the exclusion criteria: * with at least one blood relative with known pathogenic germline mutation(s). for blood relatives verifying germline mutation, the inclusion criteria: all of the following three points should be satisfied: * first- to second-degree blood relatives of probands with germline mutation(s). * with sufficient tumor tissue and normal tissue to test. * agree to provide basic information, clinical information and family history of cancer information. for blood relatives verifying germline mutation, the exclusion criteria: * blood relatives who refuse to test.

Keywords: lynch syndrome mismatch repair microsatellite instability next-generation sequencing immunohistochemistry
dolastatin 10 in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of dolastatin 10 in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.

objectives: i. determine the objective response rate in patients with hormone refractory prostate cancer treated with dolastatin 10. ii. determine the toxicity of this regimen in this patient population. outline: patients receive dolastatin 10 iv bolus every 3 weeks. treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. projected accrual: a total of 15-30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: hormone refractory metastatic prostate cancer (stage d1 or d2) with no greater than 3 prior endocrine manipulations psa level increased on 3 consecutive measurements at least 2 weeks apart psa at least 10 ng/ml (not required if measurable disease) patient characteristics: age: not specified performance status: swog 0-2 life expectancy: at least 12 weeks hematopoietic: granulocyte count at least 1,500/mm3 hemoglobin at least 8 g/dl platelet count at least 100,000/mm3 hepatic: bilirubin less than 2 mg/dl ast no greater than 2 times upper limit of normal renal: creatinine less than 2.0 mg/dl other: no other serious medical illness no serious infection no other prior malignancy within the past 5 years except nonmelanoma skin cancer or any in situ carcinoma prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: see disease characteristics concurrent lhrh-agonist therapy allowed without antiandrogens at least 4 weeks since prior flutamide and nilutamide at least 6 weeks since prior bicalutamide at least 4 weeks since other prior hormone therapy including steroids radiotherapy: at least 4 weeks since prior radiation therapy and recovered no prior strontium surgery: recovered from prior surgery

Keywords: stage iv prostate cancer recurrent prostate cancer
intubation prediction in covid-19 patients treated with awake prone positioning

Conditions: Acute Hypoxemic Respiratory Failure; SARS-CoV-2 Virus

Summary: retrospective study in sars-cov 2 patients hospitalised in icu. we aim to explore the effects of awake prone positioning on oxygenation and intubation rate.


Eligibility criteria:
inclusion criteria: * sars-cov-2 pneumonia * icu stay * severe hypoxemia but non intubated exclusion criteria: * intubated before admission * denied consent for data analysis * do not intubate order at icu admission