Kornimate/medical-research-clean huggingface dataset:
plasma proteomic biomarkers for early diagnosis of lung cancer

Conditions: Lung Cancer

Summary: we will identify plasma proteomics biomarkers for early diagnosis of lung cancer.

we will use tmt-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients and controls. artificial intelligent (ai) assisted proteomics classifier will be developed for early diagnosis of lung cancer.

Eligibility criteria:
inclusion criteria: * ct screening results showed that the size of pulmonary nodules was more than 5mm * no treatment related to pulmonary nodules/lung cancer (including surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.) * complete clinical and imaging data * chest ct/ low-dose spiral ct reports can be provided in the last 3 months * voluntarily sign informed consent exclusion criteria: * there is a history of tumor * clinically uncontrolled active infections, such as acute pneumonia, tuberculosis, etc. * received any treatment related to pulmonary nodules, such as antibiotics and hormones, in the past 4 weeks * complicated with other tumors and serious diseases of the heart, liver, kidney, brain, blood and other systems * participated in other clinical trials within the last 3 months * combined with liver and kidney insufficiency, hypoproteinemia and other diseases affecting protein content * you are pregnant or breastfeeding
effect of cytokine-induced killer cells for stage i-ii malignant gliomas

Conditions: Cytokine-Induced Killer Cells; Milignant Gliomas

Summary: the purpose of this study is to determine whether combining of temozolomide and cytokine-induced killer cells (cik) transfusion can prolong survival of patients with malignant gliomas. the effectiveness and safety of cik cells for the treatment of malignant glioma is also evaluated.


Eligibility criteria:
inclusion criteria: histologically confirmed intracranial grade 1 or 2 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma). received prior standard radiation for a grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 gy administered. completed at least one full cycle of temozolomide of 200 mg/m2/day administered on days 1-5 of a 28-day cycle, without unacceptable toxicity or progression. karnofsky performance status of 60 or more. adequate organ and bone marrow function as defined by hematological and serum chemistry limits. at least 18 years old. both men and women must practice adequate contraception. informed consent. exclusion criteria: progressed while on temozolomide. evidence of acute intracranial or intratumoral hemorrhage \> grade 1. not recovered from the toxic effects of prior therapy. pregnant or breast feeding. history of diabetes mellitus. uncontrolled intercurrent illness. congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study. hiv positive. diagnosis of another malignancy may exclude subject from study.

Keywords: cytokine-induced killer cells milignant gliomas temozolomide
a randomized controlled trial to evaluate the effect of white noises and parental voices as protectors against noise damage in a neonatal intensive care unit

Conditions: Premature Infant Disease

Summary: the goal of this randomized controlled trial is to test the efficacy of listening to white noises and parental voices against environmental noise damage in premature babies admitted to the newborn intensive care unit. the main question it aims to answer is: • could the combined use of white noises and maternal and/or paternal voices reduce the negative outcomes of continuous exposure to hospital noises on newborns hospitalized in a neonatal intensive care unit? participants in the intervention group will listen to a recorded track composed of white noises and voices of their parents who read a story or sing a lullaby from the day of enrollment until the day of discharge, for 4 hours per day. researchers will compare the intervention group with the control group (who will receive the usual care provided without any intervention on the noise level) to see if babies enrolled in the intervention group show fewer events of tachycardia, tachypnea, desaturation, apnoea, and language or hearing impairment.


Eligibility criteria:
inclusion criteria: * patients admitted to the nicu with gestational age at birth ≥ 31 weeks (as this is the age at which sound perception is ≥ 40 db and there is predictable clinical stability to allow intervention delivery without excessive interruptions) * patients admitted to the nicu who reach gestational age ≥ 31 weeks * patients monitored with the following types of monitors: masimo rainbow set™ (masimo); infinity® delta (draeger); infinity® acute care system (draeger); efficia cm (philips). exclusion criteria: * patients with gestational age at birth \< 31 weeks * patients affected by meningitis or severe cerebral insults, congenital brain anomalies, congenital syndromes with suspected or known brain dysfunction * patients diagnosed with hypoxic-ischemic encephalopathy * patients with significant airway abnormalities resulting in altered breathing during sleep * patients with terminal illnesses * patients with congenital anomalies of the face, ears, skull, or brain * patients with non-bacterial congenital infections * patients with congenital hearing deficits * patients whose parents or legal guardians refuse to participate in the study * patients already enrolled in other clinical studies.

Keywords: premature nursing care randomized controlled trial developmental care noises damage newborn intensive care unit white noises parental voices
lllt for reducing waste circumference and weight

Conditions: Weight Loss

Summary: the purpose of this research is to gather preliminary information on the effectiveness of low level laser therapy (lllt) in helping people reduce their weight gain in the central body region.

this will be an open label clinical trial with all study participants receiving lllt. preliminary data will be collected on the efficacy of lllt based on varying frequency of treatments. the focus of this study on 60 overweight adults with a bmi of 25 to 29.9, and assess changes in weight and waist circumference at end of treatment for group 1 (week 4) and group 2 (week 6) and group 3 (week 12). participants will be randomized to receive lllt treatments either 3 times a week; 2 times a week; or once a week.

Eligibility criteria:
inclusion criteria: 1. over 18 years of age; 2. body weight of greater than 50 kg (110 pounds); 3. bmi between 25-29.9 kg/m2; 4. able to participate fully in all aspects of the study 5. understood and signed study informed consent exclusion criteria: 1. used weight loss medications or participated in a weight loss program within past 30 days 2. currently taking supplements known to affect weight (garcinia cambogia, etc.) 3. weight fluctuations of 20 pounds or more in the past 6 months 4. implanted device (including pacemaker or lap band) in the targeted area of lllt 5. known active eating disorder 6. known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression) 7. used an investigational drug within 30 days of study enrollment 8. currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the medication phase and unwilling to use a reliable form of contraception 9. history of any major cardiovascular events 10. current uncontrolled hypertension 11. clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease 12. prior surgical intervention for body sculpting/weight loss 13. medical, physical, or other contraindications for body sculpting/weight loss 14. any medical condition known to affect weight levels or to cause bloating or swelling 15. diagnosis of, and/or taking medication for, irritable bowel syndrome 16. active infection, wound or other external trauma to the areas to be treated with the laser 17. known photosensitivity disorder; 18. current active cancer or currently receiving treatment for or within 1 year of cancer remission
correlates of crci and gut microbiome dysbiosis; a pilot study

Conditions: Cancer

Summary: the aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.

cancer-related fatigue is experienced by nearly all patients during treatment, and cancer-related cognitive impairment (crci), which is a decrease in neurocognitive functioning that can be caused by cancer or its treatment, is present in up to ¾ of patients during treatment. fatigue and crci have both been linked to the composition of the gut microbiome in cancer patients. crci is often reported as one of the most debilitating and life-altering aspects of cancer and treatment. although crci is widely reported in patients with a variety of cancers and undergoing a variety of treatments, it is not clear if the mechanisms leading to symptoms are the same throughout. using identical methods to monitor crci symptoms and microbial dysbiosis in a cross-section of various cancers, cancer stages, and treatments, can help to identify commonalities associated with symptoms. specific aims specific aim 1: characterize the microbiome of cancer patients and compare to healthy control subjects from previous studies. specific aim 2: assess fatigue in cancer patients and determine associations with composition of the gut microbiome.

Eligibility criteria:
inclusion criteria: 1. current diagnosis of cancer. 2. ages 18 and over. 3. has access to a device (smart phone, computer, tablet) with internet access. 4. participant is willing and able to give informed consent for participation in the study. exclusion criteria: 1. females who are pregnant or lactating. 2. other medical conditions or medications deemed exclusionary by the study investigators.

Keywords: microbiome fatigue cognition
china lung cancer screening (clus) study version 2.0

Conditions: Lung Neoplasms

Summary: our previous study, china lung cancer screening study version 1.0, had proven that ldct led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (nct02898441). the present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 high-risk subjects (age 45-75) were recruited to take ldct screening. (baseline + 2 biennial repeated ldct screening). follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. blood samples were stored in a biobank. management of positive screening test was carried out by a pre-specified protocol.


Eligibility criteria:
inclusion criteria: * eligible participants were those aged 45-75 years, and with either of the following risk factors: 1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years; 2. malignant tumors history in immediate family members; 3. personal cancer history; 4. professional exposure to carcinogens; 5. long term exposure to second-hand smoke; 6. long term exposure to cooking oil fumes. exclusion criteria: 1. had a ct scan of chest within last 12 months 2. history of any cancer within 5 years
study evaluating the efficacy of niraparib and dostarlimab (tsr-042) in recurrent/metastatic hnscc

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic hnscc patients.

recurrent and/or metastatic hnscc patients will be treated with combination of the pd-1 inhibitor (dostarlimab) and parpi (niraparib) concurrently and orr, pfs and os will be determined.

Eligibility criteria:
inclusion criteria: * histologically, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous hnscc for which there are no surgical or radiation curative options. * ecog performance status ≤2 * patients must be able to swallow pills exclusion criteria: * nasopharyngeal and salivary gland tumors * patients who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia * prior exposure to both immunotherapy drugs (pd-1, pdl-1, ctla-4 inhibitors) and parp inhibitors. single exposure to either immunotherapy or parp inhibitors is allowable. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab. * patients with uncontrolled intercurrent illness. * requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.
lentiviral-mediated gene therapy of fanconi anemia patients subtype a

Conditions: Fanconi Anemia

Summary: this is an open, phase i / ii clinical trial to evaluate the safety and efficacy of a hematopoietic gene therapy procedure with an orphan drug consisting of a lentiviral vector carrying the fanca gene for patients with fanconi anemia of subtype a . cd34 + cells derived from bone marrow and / or mobilized peripheral blood (fresh and / or cryopreserved) from patients with fanconi subtype a (fa-a), will be transduced ex vivo with a lentiviral vector carrying the gene fanca (orphan drug) . after transduction the cells will be inoculated in patients in order to restore their hematopoiesis with genetically corrected stem cells.

the main objective of this open-label phase i / ii clinical trial is to evaluate the safety and therapeutic efficacy of a hematopoietic gene therapy procedure with an orphan drug consisting of a lentiviral vector carrying the fanca gene for patients with fanconi's anemia subtype a. the drug to be administered to the patients consists of the cellular product resulting from the transduction of autologous cd34 + cells with the therapeutic lentiviral vector pgk-fanca.wpre \*. the dose of cells to infuse in the patients will be that obtained from the transduction process of between 3x10\^5 and 4x10\^6 cd34 + cells / kg of patient body weight. the cells will be infused intravenously in a single dose, after complete the transduction process. follow-up period: 3 years after infusion of transduced cells. however, patients will be monitored outside the clinical trial over a 10-year period. follow-up of the grafted transduced cells will be performed on peripheral blood and bone marrow samples.

Eligibility criteria:
inclusion criteria: * patients diagnosed with fanconi anemia complementation group a (fa-a) * minimum age 1 year * maximum age 21 years * lansky index\> 60%. * informed consent in accordance with current legal regulations. * number of cells to be transduced: at least 3x10\^5 purified cd34+ / kg body weight. * negative result in the urine pregnancy test at the baseline visit for women of childbearing age, who should be committed to using an effective contraceptive method during the period of study participation. exclusion criteria: * patients with an human leukocyte antigen (hla) identical family donor. * evidence of myelodysplastic syndrome or leukemia, or cytogenetic abnormalities predicting the same in bone marrow aspirates. in this case, the studies carried out two months in advance of the patient's entry into the clinical trial will be considered valid. * evidence that the patient to be infused has signs of somatic mosaicism, with hematologic improvement. * any illness or concomitant process that in the opinion of the investigator incapacitates the subject for their participation in the study. * pre-existing sensory or motor impairment\> = grade 2 according to the national cancer institute (ncl) criteria. * pregnant or lactating women.
safety, tolerability and pharmacokinetics of dkf-310 ( (donepezil).

Conditions: Alzheimer's Disease

Summary: this is a study to evaluate safety, tolerability and pk of dkf-310 im injection in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * men aged 19 to 50 years * body weight 55 to 90 kg and bmi 18.0 to 27.0 * voluntarily signed the informed consent form * eligible according to the screening test results * available to follow up after drop-out exclusion criteria: * clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases * hypersensitivity to donepezil, piperidine derivatives and other drugs * sbp \ 150 mmhg, or dbp \ 100 mmhg * skin and muscle disorders or history of surgery at the injection site * ast or alt \>1.5xuln; qt/qtcb interval \>450 ms * history or positive result of drug abuse * prescribed drugs or herbal medicines within 2 weeks, over-the-counter drugs or vitamins within 1 week * participated in other clinical trials within 3 months * donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month * alcohol consumption \>21 units/week * smoked \>10 cigarettes/day within 3 months * caffeine-containing foods * not eligible due to other reasons at the investigator's discretion
de-labeling of patients with false diagnosis of penicillin allergy

Conditions: Allergy Drug

Summary: the purpose of this study is to estimate the prevalence of penicillin allergy, evaluate the diagnostic value of the allergologic work-up used in the study, and the health effects of penicillin allergy.

penicillin allergy is the most common of self-reported drug allergies and un-verified penicillin allergy is a significant and growing public health problem. 10% of all patients report penicillin allergy. however, there is large discrepancy between reported penicillin allergy and true allergy. despite its high prevalence, greater than 90% of such patients are in fact able to tolerate the medication without allergic reactions. in this study patients having a penicillin allergy label will be investigated to confirm or to exclude the allergy diagnosis. the diagnostic value of the allergen test panel and the allergologic work-up will be evaluated. clinical parameters as well as immunological will be assessed.

Eligibility criteria:
inclusion criteria: * adult patients who are referred to the department of pulmonary medicine with clinical history suspected of having penicillin allergy. * the control group will be healthy adult volunteers with no history of any personal or family history of drug allergy, atopy, inflammatory or autoimmune diseases. exclusion criteria: * systemic reactions such as dress, any internal organ involvement * clinical history of type ii-iii hypersensitivity reaction * severe type iv hypersensitivity reaction such as stevens-johnson syndrome, toxic epidermal necrolysis, dress, vasculitis, acute generalized exanthematous pustulosis * chronic idiopathic urticaria on antihistamine maintenance treatment/anti-ige treatment * medication which can affect the test outcome * active signs of an underlying disease such as uncontrolled asthma * cardiac disease with increased risk of serious anaphylaxis * pregnancy/breastfeeding * reaction within the last 4-6 weeks

Keywords: penicillin/b-lactams
corneal confocal microscopy to detect diabetic neuropathy in children

Conditions: Type 1 Diabetes; Neuropathy; Retinopathy

Summary: the overall aim of this study is to confirm the utility of corneal confocal microscopy (ccm) as a new technique to rapidly and non-invasively assess diabetic neuropathy (dn) in children. this study will be divided into two phases: phase 1 will be a cross-sectional study of children with type 1 diabetes and normal controls, while phase 2 will be a longitudinal assessment of a subgroup of children with type 1 diabetes recruited during phase 1.

in phase 1: to compare corneal nerve density (cnd), length (cnl), and branching (cbd) by ccm between 1. children with type 1 diabetes for 5 years or more to children without diabetes; 2. children with type 1 diabetes with and without evidence of diabetic neuropathy; 3. to examine the relationship between cnd, cnl \& cbd and known risk factors of diabetic neuropathy in phase 2: 1. to examine for changes in corneal nerve morphology two years after the initial ccm exam. 2. to describe the evolution of diabetic neuropathy based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction. 3. to assess if changes in corneal nerve morphology correlate with changes in nerve conduction velocity and autonomic testing. 4. to examine the risk factors associated with progression of diabetic neuropathy in our pediatric population.

Eligibility criteria:
inclusion criteria: * cases: children with type 1 diabetes 8 to 18 years old followed at the alberta children's hospital diabetes clinic with a duration of diabetes of at least 5 years. * controls: healthy children aged 8 to 18 years. exclusion criteria: * patients with known history of corneal abnormality, trauma, or surgery * any other cause of neuropathy * individuals with uncontrolled hypothyroidism * individuals with celiac disease * other serious chronic illnesses besides diabetes * inability to cooperate with testing * families unwilling to provide written informed consent

Keywords: confocal microscopy cornea neuropathy detection diabetes