Kornimate/medical-research-clean huggingface dataset:
a study of the relationship of gut microbial composition and stroke outcome

Conditions: Ischemic Stroke

Summary: the purpose of this study is to investigate the relationship between gut microbiome (bacteria in the gut), inflammation and the injured brain. it has been established that bacteria in the gut play key roles in digestion, nutrition absorption and immune response of the entire body. human intestinal bacteria composition in the gut has been associated with several stroke risk factors including obesity, insulin resistance, diabetes and hypertension. if we can establish a relationship between gastrointestinal microbial community composition and ischemic stroke outcomes could lead to dietary interventions in the future to improve recovery after a stroke.


Eligibility criteria:
inclusion criteria: 1. men and women at least 18 years of age. 2. willing and able to attend all study visits. 3. english speaking. 4. must have had a stroke that occurred within 48 hours of admission to the stroke unit as determined by a neurologist. exclusion criteria: 1. history of inflammatory bowel disease. 2. receiving antibiotics within 30 days of entry into the study. 3. history of institutionalization for mental illness within the last year. 4. unable to consent and does not have a surrogate available to consent on their behalf.
selenium to improve neurological outcome after cardiac arrest

Conditions: Cardiac Arrest

Summary: after cardiac arrest and successful resuscitation it can happen that the brain function of a patient is impaired because the brain was without oxygen for a prolonged period of time. several strategies have been studied to improve brain function after cardiac arrest. cooling of the patients is routinely used today. the trace element selenium has several biological functions and is important for defense mechanisms against oxidative stress, which occurs after cardiac arrest and successful resuscitation. critically ill patients have low selenium blood levels. therefore the investigators hypothesize that giving selenium after cardiac arrest and successful resuscitation might improve brain function.

when cardiopulmonary resuscitation results in the return of spontaneous circulation, intensive care is required to optimize neurological recovery. the pathophysiological reactions that follow hypoxic brain injury are complex, and the mechanisms by which ischemia causes neuronal death leading to postanoxic encephalopathy are only partly understood to date. therapeutic hypothermia improves brain function after cardiopulmonary resuscitation. injury however can be ongoing even after the return of spontaneous circulation, giving the clinician an additional window of opportunity to treat and protect the injured brain \[5\]. therefore there is an unmet clinical need for further therapeutic strategies. strategies to counteract the deleterious effects of oxygen-derived free radicals after cerebral reperfusion have been studied for long. the trace element selenium is part of the enzyme glutathione peroxidase which belongs to the endogenous defence mechanisms against oxidative stress. clinical data suggest that supplementation of selenium may be beneficial in critically ill patients and in neurodegenerative diseases including, among others, parkinson's disease, stroke, and epilepsy, where oxidative stress plays an important pathophysiological role. in sirs, sepsis and septic shock doses up to 4000µg per day have been proven to be safe a recent retrospective analysis supported the hypothesis that early administration of selenium may improve neurological outcome after cardiac arrest. therefore the purpose of this study is to explore the influence of early administration of selenium on neurological outcome after cardiopulmonary resuscitation by a randomized, placebo-controlled, single-center study.

Eligibility criteria:
inclusion criteria: * cardiac arrest * successful resuscitation * age \>18 exclusion criteria: * polytrauma * pregnancy * any condition that makes it likely that the patient will not survive 24 hours

Keywords: cardiac arrest resuscitation neurological outcome
biomarkers for angiogenesis in renal cell carcinoma and neuro-endocrine tumours.

Conditions: Carcinoma; Carcinoma, Renal Cell; Neuroendocrine Tumors; Carcinoid Tumor; Pancreatic Islet Cell Tumors

Summary: the primary objective of this study is to analyse the concentration dopamine and serotonin in thrombocytes of patients with renal cell carcinoma and neuro-endocrine tumours compared to the concentrations of these catecholamines in healthy volunteers. the concentration dopamine and serotonin in thrombocytes with and without medication will also be evaluated.

* to analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and low grade neuroendocrine tumours. * to compare these concentrations with the concentrations catecholamines in thrombocytes of healthy controls. * to analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and patients with low grade neuroendocrine tumours with and without medication.

Eligibility criteria:
inclusion criteria: * age 18 years old or older. * patients with clear cell renal cell carcinoma with metastases or patients with a low-grade neuro-endocrine tumor with metastases. * written informed consent exclusion criteria: * use of l-dopa or ssri. * patients with a second primary malignancy.

Keywords: angiogenesis inhibitors neoplasms, glandular and epithelial neoplasms by histologic type neoplasms adenocarcinoma kidney neoplasms urologic neoplasms urogenital neoplasms neoplasms by site kidney diseases angiogenesis inducing agents biological markers
automated extracranial internal carotid artery ultrasound sensor for traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) affects 1.7 million people in the united states each year, resulting in 2.5 million emergency department visits, 280,000 hospitalizations, \>50,000 deaths, and more than $60 billion in economic cost. tbi also affects \>30,000 military personnel annually and almost 8% of veterans who received care between 2001 and 2011. post-traumatic neurologic outcome depends on the severity of initial injuries and the extent of secondary cerebral damage. ischemia is the most common and devastating secondary insult. ischemic brain damage has been identified histologically in \~90% of patients who died following closed head injury, and several studies have associated low cerebral blood flow (cbf) with poor outcome. specifically, cbf of less than 200 ml/min has been shown to be the critical lower threshold for survival in neurointensive care patients. in addition to intracranial hypertension and cerebral edema, systemic hypotension and reduced cardiac output contribute substantially to posttraumatic cerebral ischemia. additionally, the carotid artery is the most common site of blunt cerebral vascular injury (bcvi), which may further compromise cbf and cause subsequent death or debilitating stroke. specifically, high grade internal carotid arterial (ica) injuries are associated with the highest mortality and stroke rate. the investigators' goal is to develop of a wearable noninvasive, continuous, automated ultrasound sensor to accurately measure extracranial ica flow volume. in doing so, the investigators aim to enable early detection of cbf compromise, thereby preventing secondary ischemic injuries in tbi patients. to achieve this goal, the investigators plan to first build a prototype wearable ica ultrasound senor with integrated signal processing platform, then test its accuracy in an in vitro system and healthy human subjects.


Eligibility criteria:
inclusion criteria: * healthy volunteers * age 18 or older exclusion criteria: * claustrophobic * hyperventilation or panic disorders * pregnant * have metal implants or cannot pass the mri screening questions
testosterone & tamoxifen trial

Conditions: Male Breast Cancer

Summary: this is a concise single arm, feasibility study, which will be executed in the university medical center groningen, the netherlands. male patients with metastatic bc (n=6) are eligible for this study after at least 1 line of conventional endocrine therapy.


Eligibility criteria:
inclusion criteria: 1. male 2. a history of proven er+ (\>10% of cells), ar+ (\>10% of cells), and her2- metastatic bc 3. tumor progression after at least one line of conventional endocrine therapy (tamoxifen, ai, fulvestrant, cdk4/6, ±lhrh analogue). 4. age ≥ 18 years 5. adequate hematological, renal and liver function as follows: * absolute neutrophil count \> 1.5 x 109/l * platelet count \>100 x 109/l * white blood cell count \>3 x 109/l * ast and alt \<2.5 or \<5.0 in case of liver metastases x upper limit of normal (uln) * creatinine clearance \>50ml/min * prothrombin time, partial thromboplastin time and inr \<1.5 x uln 6. written informed consent exclusion criteria: 1. history of prostate, testicular or liver cancer 2. patients already using testosterone supplements 3. patients using medication with anti-androgenic effects (e.g. spironolactone) 4. elevated psa (\>4μg/l) or severe urinary tract problems (as defined with a prostate symptom score \>19). patients with known brca mutation and psa \>3 μg/l will be referred to the urologist for prostate cancer screening, and can participate if they have no signs of prostate cancer. 5. hematocrit \>50% 6. patients with uncontrolled hypertension, diabetes mellitus or other significant cardiovascular morbidity. 7. patients with recent history of coronary artery disease or trombo-embolic events within 6 months prior to screening 8. severe concurrent disease, infection, co morbid condition that, in the judgment of the investigator would make the patient inappropriate for enrollment 9. visceral crisis and/or rapid progression necessitating chemotherapy 10. previous allergic reaction to androgen agonists 11. contra-indication for pet imaging 12. tamoxifen or fulvestrant treatment \<5 weeks prior to fes-pet.
cohort study on the effects of aging in acquired brain injury patients

Conditions: Acquired Brain Injury; Subarachnoid Hemorrhage; Traumatic Brain Injury; Cerebrovascular Accident

Summary: a prospective cohort study (questionnaires), with an embedded case control study (neuropsychological assessments) in which the data is gathered within a timeframe of 3 years. a group of 700 patients and a group of 100 healthy volunteers will be participating.

in the netherlands an estimated 650.000 people live with the daily consequences of an acquired brain injury (abi). a substantial amount of these patients acquired their brain injury (traumatic brain injury, subarachnoid hemorrhage or cerebrovascular accident) at a relatively young age: between 18 and 50 years old. the chain-of-care for abi aims for recovery in the subacute phase, usually within a period of one year after injury. after an adaptation period, the patients reach a new balance, with stabilization of complaints and reintegration, sometimes with the necessity of modifications. the group of patients who acquired a brain injury at a young age, have to face the effects of aging like decreased cognitive functions, which can cause the participation level to drop. this is called the abi-effect in the current study. at this moment, insufficient information is available about the functioning of people who suffered abi multiple years ago and have established a new balance, and now make the transition to an older phase of live. primary objective: explore the prevalence of the abi-effect, by mapping the participation level. secondary objective: substantiate the occurence of the abi-effect, by mapping cognitive functions of patients and compare these to healthy controls. tertiary objective: gain insight in the need of care for patients, to enhance regular care after abi.

Eligibility criteria:
inclusion criteria: * current age range between 50-67 years \[rationale: having an age that enables the patient to experience the effects of aging with a low risk of neurodegenerative disease\] * able to complete questionnaires independently additionally, patients must also meet the following criteria: * age of acquiring the abi ≧ 25 years \[rationale: the brain is supposed to be fully developed at a maximum capacity * abi must be ≧ 5 years ago\] \[rationale :time period regarded sufficient to have achieved a stable level of cognitive functioning and participation after an abi\] * abi diagnosis at hospital admission with abnormalities at the brain-ct or mri * independent regarding activities of daily living * not living in a long-term care facility exclusion criteria: * psychiatric disease (for which participant is currently treated) * accompanying disease with reduced life expectancy * neurological disease (including recurrent abi for patients) * language barriers prohibiting and completion of dutch questionnaires * alcohol or drug abuse * suspected neurodegenerative disease
biobank cardiac surgery

Conditions: Cardiovascular Diseases

Summary: treatment strategies for cardiac surgery patients have been evolving significantly for the last decade. while clinical outcomes have been improving, there are still significant areas unexplored in these patients. cardiac surgery, or cardiovascular surgery, is surgery on the heart or great vessels performed by cardiac surgeons. it is often used to treat complications of ischemic heart disease (for example, with coronary artery bypass grafting); to correct congenital heart disease; or to treat valvular heart disease from various causes, including endocarditis, rheumatic heart disease, and atherosclerosis. biobanking is a fundamental process required in the better understanding of human diseases together with their underlying mechanisms. biobanking refers to the process by which samples of bodily fluid or tissue are collected for research use to improve the understanding of health and disease. for this study, the investigator's objective is to acquire elucidation in disease etiology, translation, and advancing public health by evaluating blood and tissue results of those with cardiac disease undergoing cardiac surgery.


Eligibility criteria:
inclusion criteria: * all patients who undergo cardiac surgery at advocate children's hospital (ach)\& university of chicago medical center (ucmc) by the ach \& uc cardiothoracic surgery research team who are pediatric neonates and up. * patients will only be english speaking. exclusion criteria: * vulnerable subjects/subject capacity to provide consent
the changes of cytokines during antiviral therapy

Conditions: Chronic Hepatitis B Infection

Summary: pegylated interferon α-2a(peg-ifn-α) not only inhibit viral replication, but also play an important role in immune regulation, while nucleoside analog(ue) drugs only inhibit viral replication. in hepatitis b infection, cytokines played a vital role. this study was aimed at investigating the changes of cytokines during peg-ifn-αand nucleoside analog(ue) therapy.meanwhile, the investigators wanted to verify whether peg-ifn-α therapy resulted in the secretion of cytokines.

pegylated interferon α-2a(peg-ifn-α)and nucleoside analog(ue) drugs can inhibit viral replication , but peg-ifn-α also play an important role in immune regulation . in hepatitis b infection, cytokines including fit-3l, ifn-alpha2, ifn-gama, il-10, il-17a,il-2, il-6, tnf-alpha, tgf-beta1, tgf-beta2,tgf-beta3, played a vital role.peg-ifn-α recommended as the first-line treatment has a higher chance to achieve hbeag seroconversion and even hbsag disappearance than nucleoside analog(ue) drugs, which might be related to the increase of cytokine secretion in the case of hepatitis and during peg-ifn-α therapy.this study was aimed at investigating the changes of cytokines during peg-ifn-αand nucleoside analog(ue) therapy.meanwhile, the investigators wanted to clarify whether peg-ifn-α therapy led to the secretion of cytokines.

Eligibility criteria:
inclusion criteria: * hbsag and hbeag positive for more than 6 months, hbv dna detectable with alt level abnormal lasted for three months and at least time190 iu/l or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled. exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver

Keywords: chronic hepatitis b hepatitis b virus cytokines pegylated interferon α-2a nucleoside analogues
predictive response to chemotherapy (folfox or folfiri) by ex vivo culture 3d technique in metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture 3d (chemogram obtaining) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (folfox or folfiri) for colorectal cancer.

the culture 3d study is a prospective, open labelled, multicenter trial. the aim is to evaluate the feasibility of ex vivo culture 3d (chemogram) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (folfox or folfiri) for colorectal cancer. patients will have biopsies in a metastasis or in the primitive tumor before treatment. the sample will be used for a 3d ex vivo cells culture. a chemogram will be made based on cells proliferation data (ki67) and apoptosis (m30). results from this chemogram will not interfere with the treatment combination choice. the treatment response will be evaluated by the recist assessment and will be then compared to the chemogram.

Eligibility criteria:
inclusion criteria: 1. aged 18 years old or more 2. colorectal cancer with synchronous or metachronous metastases 3. metastasis and/or primitive tumor (in case of synchronous metastases) accessible to biopsy 4. measurable metastatic disease (echography, ct and/or mri, pet-fdg) 5. indication for treatment with a combination including folfox/folfiri associated to an anti vegf drug (avastin) 6. no adjuvant chemotherapy for the primitive colorectal cancer and no line of chemotherapy for metastatic disease during the year prior to inclusion. 7. life expectancy \> 3 months (ecog 0-1-2). 8. informed and signed consent by the patient. exclusion criteria: 1. elevation of carcinoembryonic antigen (cea) without measurable metastatic disease 2. medical contraindication to chemotherapy or biotherapy as folfox/folfiri or avastin. 3. treatment with folfox/folfiri and biotherapy anti-egfr (epidermal growth factor receptor)(erbitux) planned 4. patient already enrolled in an other clinical trial with another first line of chemotherapy. 5. pregnant women, breastfeeding or of childbearing age not taking contraceptive 6. persons deprived of liberty. 7. subject unable to make follow up schedule

Keywords: 3d culture chemogram folfox folfiri
rituximab and cyclophosphamide in treating patients with high risk, refractory, or relapsed multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: monoclonal antibodies, such as rituximab, can block cancer growth in different ways. some block the ability of cancer cells to grow and spread. others find cancer cells and help kill them or carry cancer-killing substances to them. drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. giving rituximab together with cyclophosphamide may kill more cancer cells. purpose: this phase ii trial is studying how well giving rituximab together with cyclophosphamide works in treating patients with high risk, refractory, or relapsed multiple myeloma.

objectives: * determine the effect of rituximab and high-dose cyclophosphamide on the growth of myeloma stem cells in patients with high-risk, refractory, or relapsed multiple myeloma. outline: patients receive rituximab iv on days -10 and -7; once weekly for 4 weeks (after completion of high-dose cyclophosphamide); and then once in months 3, 6, 9, and 12. patients also receive high-dose cyclophosphamide on days -3 to 0. projected accrual: not specified.

Eligibility criteria:
disease characteristics: * diagnosis of multiple myeloma, meeting 1 of the following criteria: * high-risk disease in first remission, as defined by the following: * beta-2 microglobulin \> 5.0 mg/dl * chromosome 13 deletion * primary refractory disease * relapsed disease after achieving a response to prior chemotherapy * the following diagnoses are not allowed: * poems syndrome * plasma cell leukemia * amyloidosis * nonsecretory myeloma * no evidence of spinal cord compression patient characteristics: age * over 18 performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * not pregnant or nursing * fertile patients must use effective contraception * hiv negative * has good organ function * is in good physical condition * no active infection requiring antibiotics * no other malignancy within the past 2 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy * no persistently detectable donor cells after prior allogeneic stem cell transplantation * no prior rituximab chemotherapy * see disease characteristics endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * at least 28 days since prior therapy

Keywords: stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma refractory multiple myeloma
quikclot control+ hemostatic dressing use in mild to moderate bleeding

Conditions: Hemostasis

Summary: quikclot control+ hemostatic dressing (quikclot+) is indicated for temporary control of internal organ space bleeding for patients displaying class iii or class iv bleeding. it may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. quikclot control+ is also indicated for temporary control of mild to moderate bleeding in cardiac surgical procedures. quikclot control+ is also indicated for use to control bleeding from bone surface following sternotomy.


Eligibility criteria:
inclusion criteria: * age range greater than or equal to 18 years old * willing and able to give prior written informed consent * requiring cardiac surgery exclusion criteria: * subject undergoing emergency surgery for any reason * subject has active or potential infection at the surgical site or endocarditis * egfr less that lo ml per minute * subject who is currently participating in an investigational drug or another device trial (excluding registries) * leucopenia (wbc \< 3.5x 103/µl), or acute anemia (hgb \< 10.0 mg/dl or 6 mmol/l), or thrombocytopenia (platelet count \< 50x 103/µl), or history of bleeding diathesis or coagulopathy, or hit positive * other medical, social, or psychological conditions that, in the opinion of the investigator, precludes the subject from appropriate consent or adherence to the protocol required follow-up exams * active illicit drug use, verbally confirmed with the patient * severe liver dysfunction confirmed via child-pugh of b-c or meld \> 10 * female who is pregnant at screening. confirmation by urine or serum pregnancy test * incarcerated or unable to give voluntary informed consent