Kornimate/medical-research-clean huggingface dataset:
cetuximab-irdye 800cw in detecting tumors in patients with malignant glioma undergoing surgery

Conditions: Brain Neoplasm; Malignant Glioma

Summary: this study is a phase 1-2 trial that evaluates the best dose of cetuximab-irdye 800cw and how well it works in detecting tumors in patients with malignant glioma who are undergoing surgery. cetuximab-irdye 800cw is an optical imaging agent that may help detect tumor cells when a special camera is used.

this is a dose-escalation study of cetuximab-irdye 800cw. patients are assigned to 1 of 2 cohorts. cohort i: patients receive cetuximab intravenously (iv) over 30 minutes and a lower dose of cetuximab irdye800 iv over 30 minutes to 1 hour on day 0. cohort ii: patients receive cetuximab iv over 30 minutes and a higher dose of cetuximab irdye800 iv over 30 minutes to 1 hour on day 0. all patients undergo standard of care surgical resection of tumor on days 2-5. after completion of study, patients are followed up at days 10 and 30. primary objective: determine the efficacy of cetuximab-irdye 800cw (cetuximab irdye800) in intraoperatively identifying malignant glioma compared to surrounding normal central nervous system tissue, as measured by tumor-to-background ratio. secondary objective: determine the tolerability of the cetuximab irdye800 as an imaging agent in subjects undergoing resection of malignant glioma.

Eligibility criteria:
inclusion criteria * suspected brain tumors to undergo removal (surgical resection) as standard of care, as assessed by the operating surgeon * life expectancy of \> 12 weeks * karnofsky performance status of at least 70% or eastern cooperative oncology group (ecog)/zubrod level 1 * hemoglobin ≥ 9 gm/dl * platelet count ≥ 100,000/mm³ * magnesium, potassium and calcium \> the lower limit of normal per institution normal lab values * thyroid-stimulating hormone (tsh) \< 13 micro international units/ml exclusion criteria * received an investigational drug within 30 days prior to first dose of cetuximab irdye800 * within 6 months prior to enrollment, myocardial infarction (mi); cerebrovascular accident (cva); uncontrolled congestive heart failure (chf); significant liver disease; or unstable angina * history of infusion reactions to cetuximab or other monoclonal antibody therapies * evidence of qt prolongation on pretreatment electrocardiogram (ecg) (greater than 440 ms in males or greater than 450 ms in females) * receiving class ia (quinidine, procainamide) or class iii (dofetilide, amiodarone, sotalol) antiarrhythmic agents * pregnant or breastfeeding
engage: managing cognitive decline through theatre therapy, artificial intelligence and social robots driven interventions

Conditions: Mild Cognitive Impairment; Older Adults

Summary: the objectives of the engage project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (mci) by providing an ecosystem of services based on an innovative system that integrates social robots.

the study is focused on older people with mild cognitive impairment, aiming to improve their quality of life and well-being, allowing them to preserve their identity, to reduce stress, memory loss, or communication challenges by the use of the technological engage system that includes the social robot pepper. the social robot can be a great tool in engaging older adults in this kind of activities. it is always available and able to provide verbal clues or suggestions according to older adult's wishes, needs and memories. moreover, the social robots may coach the older adults to perform daily activities with greater independence (i.e. coaching stepwise prompting to complete activities in-home) and support to caregivers as well. since caring for people with mild cognitive impairment puts a significant burden on informal caregivers, having the support of a technological platform can reduce anxiety, worries, and stress. the caregivers can personalize the content of interventions to the wishes and preferences of the older adults. together with the older adults, they can be involved with the robot in joyful and fun activities like drama playing, storytelling, etc. the formal caregivers who need to keep track of older adult progress which is a difficult and time-consuming process due to the lack of objective monitoring of cognitive decline and wellbeing may get valuable support from the cognitive assessment procedure implemented by the machine learning algorithm. also, the social robot and tablet may facilitate the follow-up of older adults through reminders and cognitive interventions.

Eligibility criteria:
inclusion criteria: * mild cognitive impairment (mci); * montreal cognitive assessment (moca) score 21 - 25; * memory assessment clinics - questionnaire (mac-q) ≥ 25; * reisberg scale 2 - 4; * clinical frailty scale score 1 - 3; * 4-items gds score ≤ 1; * have an informal caregiver to support in carrying out the main daily activities. exclusion criteria: * lack of informal caregivers; * significant visual or hearing impairment.

Keywords: ageing older adults mild cognitive impairment caregiver technological platform
predicting neoadjuvant therapy response of rectal cancer with mri

Conditions: Rectal Neoplasms

Summary: the purpose of this study is to investigate if mri scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. this will help doctors to better tailor treatments for rectal cancer in the future.

we proposed to constructed multi-parameter predictive model for predicting therapeutic response and pathological complete response(pcr) of patients with rectal cancer who received neoadjuvant chemoradiation. mr radiomics,convolutional neural networks, morphological parameters and quantitative functional parameters derived from diffusion-weighted mr images will be integrated for model construction.

Eligibility criteria:
inclusion criteria: * age \> 18 years * t3/4 or node positive biopsy-proved primary rectal cancer * suitable for pre-operative chemoradiotherapy and surgical resection * no contraindication to mri * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * history or concurrent of other cancer * previous therapy to pelvis * unable/unwilling to have mri * pacemaker or implanted defibrillator * pregnancy, lactation or inadequate contraception * patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study * unwilling or unable to give informed consent
differences in blood levels of lopinavir/ritonavir in hiv infected men and women

Conditions: HIV Infections

Summary: men's and women's bodies may process anti-hiv drugs differently. the purpose of this study is to determine the differences in blood levels of soft gel capsules and tablets of lopinavir/ritonavir (lpv/r) in hiv infected men and women.

it is estimated that 50% of people living with hiv/aids worldwide are women. hiv infected women face different psychosocial issues than men, and their bodies may react differently to hiv treatment. however, most of the data on the safety and efficacy of antiretrovirals (arvs) used in the treatment of hiv infection are from studies conducted primarily in men. lpv/r in tablet form was approved by the fda in october 2005. this study will determine the differences in pharmacokinetics (pk) in men and women taking a soft gel capsule and a tablet formulation of lpv/r. no arvs will be provided by this study. in step 1, participants will receive soft gel capsules of lpv/r. all step 1 participants will be asked to join step 2 of the study upon completion of step 1. in step 2, participants will receive tablets of lpv/r. during the study, participants in both step 1 and 2 will take a treatment regimen of lpv/r twice daily and one or more of the following: a nucleoside reverse transcriptase inhibitor (nrti), tenofovir disoproxil fumarate, or enfuvirtide. medical and medication history, blood collection, and clinical assessments will occur at study screening for both steps 1 and 2. participants in both steps will be asked to complete a medication diary from study entry to the day of the pk visit. the pk visit will occur within 30 days of study screening; blood collection for pk analysis will also occur at this visit.

Eligibility criteria:
note: step 1 enrollment ended as of 06/28/06. inclusion criteria * hiv infected * have taken twice-daily lpv/r (soft gel formulation for step 1 participants and tablet formulation for step 2 participants) for at least 14 days immediately prior to step screening and are willing to continue taking lpv/r until the pk visit of that step * have taken lpv/r in combination with at least one of the following for at least 14 days immediately prior to study step screening: zidovudine, lamivudine, emtricitabine, stavudine, abacavir sulfate, didanosine, zalcitabine, tenofovir disoproxil fumarate, enfuvirtide, and are willing to continue taking them until the pk visit of that step * body weight of more than 50 kg (110 lbs) for step 1 participants only exclusion criteria: * non-nucleoside reverse transcriptase inhibitor or dual protease inhibitor regimen within 30 days prior to study entry * require certain medications * current drug or alcohol abuse that, in the investigator's opinion, may interfere with the study * serious illness requiring systemic treatment or hospitalization within 30 days of study screening * acute aids-related opportunistic infection within 90 days of study entry

Keywords: kaletra treatment experienced
a study to investigate gw427353 in subjects with irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome (IBS)

Summary: this study will test the hypothesis that gw427353, a beta-3 adrenergic agonist, will relieve ibs pain or discomfort and associated symptoms in ibs patients.


Eligibility criteria:
inclusion criteria: - diagnosis of ibs which meets the rome ii criteria, screening pain score to be \> 1.5 (0= no pain, 4 = very severe pain) exclusion criteria: * subjects not meeting the rome ii criteria for the diagnosis of ibs * subjects with no stool for 7 days during the screen

Keywords: gw427353 b3-adrenergic receptor agonist irritable bowel syndrome (ibs) efficacy tolerability pharmacokinetics
covid-19 and multiple sclerosis disease modifying therapies

Conditions: Covid19; Multiple Sclerosis

Summary: the covid-19 pandemic is a major concern for people on long-term treatments that modify the immune system function. people with multiple sclerosis (pwms) form a large group who receive such treatments called disease modifying therapies (dmts). several types of dmts with different effects on the immune system are being used for multiple sclerosis (ms). in the absence of large-scale national studies, the risk of covid-19 among pwms on various dmts has not been established. a few physician-reported registry-based studies have suggested that anti-cd20 monoclonal antibodies, such as ocrelizumab and rituximab, used in the treatment of ms can increase the risk of covid-19. however, in our community-based covid-19 study of a large cohort of pwms as part of the uk ms register, we could not demonstrate an association between dmts and susceptibility to covid-19. other studies have not found any relationship between dmts and the outcome of covid-19 among pwms. to our knowledge, uk is the only country in the world that collects national data on dmt use, providing us with the opportunity to investigate the impact of dmts on covid-19 susceptibility and severity in a large population of pwms. in england, no dmt is being dispensed without prior approval and specialised commissioning by the national health services (nhs) england \& nhs improvement (nhse/i). the scheme, currently implemented in over 100 nhs trusts in england, ensures that treatment decisions are made in line with agreed commissioning policy and are evidence-based. nhse/i also has access to public health england (phe) held data on all people who have had a sars-cov-2 test. by identifying all pwms on dmts and all those who have had a test for coronavirus and collecting data on the clinical outcome of their covid-19 from their local nhs hospitals, we would be able to establish the risk of covid-19 and the risk of contracting the infection associated with different dmts. the findings of the study will help ms clinical teams address the concerns of pwms about taking dmts during the covid-19 pandemic and update their guidelines on the measures pwms need to take during these unprecedented times.


Eligibility criteria:
inclusion criteria: * age 18 or above * diagnosed with ms * received treatment with a dmt exclusion criteria: * not fulfilling the inclusion criteria

Keywords: covid19 multiple sclerosis disease modifying therapies
effect of donepezil on cognition in parkinson's disease with mild cognitive impairment (pd-mci)

Conditions: Parkinson's Disease

Summary: there have been growing interest in identifying parkinson's disease (pd) patients with mild cognitive impairment (mci) which is susceptible to progress to pd dementia(pdd). pd-mci is known to significantly correlates with low cerebrospinal beta-amyloid 1-42 and 1-40 levels, in which suggest the existence of something common with alzheimer's dementia. pdd have showed more cholinergic deficits than alzheimer's dementia and responds to donepezil. the investigators assume that pd-mci patients also have cholinergic deficits. donepezil improves cognition, and seems to be well tolerated and not to worsen parkinsonism in patients with cognitive impairment. donepezil produced similar improvements in cognition and behaviour in dlb and pdd. this supports the hypothesis that the two disorders are closely related clinically and neurobiologically. larger scale, placebo controlled clinical trials are needed to provide an evidence base to guide the clinical use of cholinesterase inhibitors in lewy body disease. it is believed that earlier intervention, later appearance of dementia should be needed to lower the socioeconomic costs and to improve the quality of life on patients and caregivers. the investigators anticipate that donepezil may delay the development of dementia in patients with pd-mci.


Eligibility criteria:
inclusion criteria: * age more than 40 years old * clinical diagnosis of pd established by queen square brain bank criteria * stable dose of levodopa at least 3 months before the study enrollment * diagnosis of mci in pd according to the movement disorder society (mds) task force guideline exclusion criteria: * diagnosis of dementia * hypersensitivity to piperidine derivatives * concomitant anticholinergics and cholinergic agents * severe cardiac arrhythmia: sick sinus syndrome, complete av block, uncontrolled arrhythmia, history of ventricular fibrillation
nicotinamide in non-alcoholic fatty liver disease patients

Conditions: Non Alcoholic Fatty Liver Disease

Summary: the purpose of the study is to evaluate the efficacy and safety of niacinamide supplementation on clinical outcome of fatty liver patients having type ii dm through measurement of the following before and after niacinamide administration: liver enzymes, lipid profie, homa-ir, oxidative stress markers and endothelial dysfunction marker. fibroscan with cap will be done at baseline and at the end of the trial. also, evaluation of quality of life of patients before and after niacinamide administration using chronic liver disease questionnaire.


Eligibility criteria:
inclusion criteria: * 1. male or female outpatients age 18 to 70 years old. 2. the diagnosis of nafld will be established according to the appearance of fatty liver on us or elevated liver enzymes (\>1.5 times normal level). exclusion criteria: * 1. history of alcohol abuse (as defined by an average daily consumption of alcohol \> 30 g/day in men and \> 20 g/day in women). 2. cirrhotic patients. * fibroscan result \> 12kpa or as * predicted from fib 4 score \> 3.25 fib-4 = age (yr) \* ast (iu/l)/platelet count (109/l) \* alt1/2 (iu/l) 3. hyper / hypoparathyroidism. 4. cancer. 5. viral hepatitis. 6. biliary disease. 7. autoimmune hepatitis 8. other causes of liver disease (hemochromatosis, wilson's disease). 9. participants who took antibiotics, probiotic supplements and/or hepatotoxic medicines (nsaids, amiodarone and methotrexate) within 6 months before the start of the study and during the study. 10. ascetic patients and congestive heart failure patients will be excluded due to unreliability of fibroscan results in them. 11. pregnancy and lactation.
study evaluating the cost of the treatments of the refractory psoriatic arthritis to the conventional therapy

Conditions: Arthritis, Psoriatic, Psoriasis

Summary: the purpose of this study is to conduct an economic analysis on the cost of conventional therapy as compared to biologic therapy and the direct/indirect costs of disease management in patients with refractory psoriatic arthritis (psa). primary outcomes are to qualify the economic burden of refractory psa care. the secondary outcomes are to assess efficacy, safety, and cost effectiveness of different therapies.


Eligibility criteria:
inclusion criteria: * eighteen years of age or older * inflammatory arthropathy associated with psoriasis meet the acr criteria for psa * patients with diagnosis of active and progressive psa who have failure with conventional treatments exclusion criteria: * significant concurrent medical diseases including cancer or a history of cancer, uncontrolled congestive heart failure, myocardial infarctions within 12 months or other clinically significant cardiovascular diseases, immunodeficiency syndromes or concomitant infectious diseases.

Keywords: rheumatoid arthritis
the effect of acupoint massotherapy on relieving chemotherapy-induced myelosupression

Conditions: Cancer, Breast; Acupressure; Hematopoiesis

Summary: in this proposed project, the investigator will estimate the effect of massotherapy of acupoints on alleviating chemotherapy-induced myelosuppression among patients with cancer.

chemotherapy is mainly used to treat and control the progression of gynecological cancer, bone marrow suppression the evil side effects after chemotherapy, which may decreasing immune function and further causes serious fatal infections. acupuncture is a valid intervention in medical practice and has been used for the improvement of chemotherapy-induced leucopenia. in a systematic meta-analysis study showed that acupoints stimulation has immunomodulatory effect for therapy induced bone marrow suppression in cancer patients. therefore, in the acupressure group, the technique used is the electric vibrating massager, and patients are taught to apply the strong mode on the 15 specific points,5 min each, 3 times a day during chemotherapy.the intervention follows the points are used to stimulate the hematopoietic function including hegu (li4), quchi (li11), xuehai (sp10); sanyin-jiao (sp6), taixi (k3), zusanli(st36), taichong (lv3); and baihui (gv20). the patients of the control group are not admitted any acupoints press-related interventions mentioned above. the purpose of this study is to evaluate the effectiveness of non-invasive acupressure on the prevention of chemotherapy-induced myelosuppression among patients with cancer.

Eligibility criteria:
inclusion criteria: * newly diagnosed of gynecologic cancer, regardless of stage. * receiving initial chemotherapy. * ability to write informed consent. * between 20 to 70 years old. exclusion criteria: * history of severe cardiac disorder. * suffering from the hematological diseases such as hemolytic anemia. * cancer patients with lymphoedema at the area of the acupressure points. * diagnosed combine with other cancers.

Keywords: cancer acupressure hematopoietic cell growth factors
descriptive and risk factors analysis of all-cause postoperative death in patients undergoing elective surgery

Conditions: Postoperative Death

Summary: the investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after elective surgery. we identify all patients treated with elective surgery, between 2000 and 2020, within the wuhan union hospital and all collaborators. the surgical patient cohort will be matched with the national death database to determine the patient's postoperative death data. 60% patients were randomly selected to the development cohort. logistic regression analysis for prediction of postoperative death adjusted for different covariates. the model was externally validated in the remaining 40% patients.


Eligibility criteria:
inclusion criteria: * patients undergoing elective surgery exclusion criteria: * patients with incomplete electronic medical record information

Keywords: postoperative death elective surgery prediction model
safety, pharmacokinetics and pharmacodynamics study of hl-032 in healthy male volunteers

Conditions: Growth Hormone Deficiency

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of hl-032 after oral administration in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * healthy male subjects * age(yr)between 19 and 50 * signed written informed consent exclusion criteria: * known hypersensitivity to octreotide or hgh(human growth hormone) * history of cardiovascular, respiratory, renal/genitourinary, gastrointestinal, neurological/psychic, cancer * alcoholic, smokers or drug abusers * other conditions which in the opinion of the investigator preclude enrollment into the study

Keywords: pharmacokinetics pharmacodynamics safety male
prevalence of cvc-associated sepsis and use of blood cultures in berlin - brandenburg

Conditions: Bacteremia

Summary: structured web-based survey in selected hospitals with intensive care units in berlin- brandenburg to collect data on the overall number of blood cultures (used) and the prevalence of (positive blood cultures in patients with) cvc - associated sepsis.

the use of cvc represents one of the major risk factors for sepsis, a highly prevalent disease in icus. blood cultures obtained prior to antibiotic administration are part of the ssc resuscitation bundle and essential for the outcome of the patient. the cdc criteria to diagnose sepsis do not take into account the overall number of blood cultures obtained and thus, lead to an underestimation of the true incidence of sepsis. up to now, few data is available on the total number of blood cultures obtained and the relation to the incidence of sepsis in german icus.

Eligibility criteria:
inclusion criteria: * intensive care units of hospitals in the inabbra alliance. * patients with bacteremia. exclusion criteria: * hospitals without intensive care unit.

Keywords: sepsis catheter blood stream infection blood culture