Kornimate/medical-research-clean huggingface dataset:
a phase i, autologous ex vivo expanded and activated nk cell, magicell-nk, infusion for colon cancer post resection study

Conditions: Colon Cancer Stage I

Summary: this is a phase i, open-label study to explore the safety profile and to find the maximum tolerated dose (mtd) or maximum feasible dose (mfd) of magicell-nk in subjects diagnosed with stage i or stage iia colon cancer post resection from a single site in taiwan. during this study, 3 dose levels of magicell-nk will be tested with a 3+3 design to determine the mtd/mfd: cohort 1, low dose (2×10\^8 cells), cohort 2, middle dose (6×10\^8 cells), and cohort 3, high dose (12\~18 ×10\^8 cells).


Eligibility criteria:
inclusion criteria: 1. a dated and signed informed consent 2. either gender and aged over 20 years old (inclusive) at date of consent 3. with histologically confirmed stage i or stage iia colon cancer 4. received curative colon resection within 4\~8 weeks prior to the screening visit and does not need adjuvant chemotherapy or radiotherapy 5. with no ≥ grade 3 postoperative complications or has been recovered and is suitable for study enrollment according to the investigator's judgment 6. with adequate hematology function: * absolute neutrophil count (anc) ≥ 1,500 cells/μl * total white blood cell (wbc) ≥ 3,000 cells/μl * platelets ≥ 100,000 counts/μl * hemoglobin ≥ 9 g/dl 7. with adequate hepatic and renal function: * serum creatinine ≤ 1.5 × upper limit of normal (uln) * total bilirubin (tb) ≤ 1.5 × uln * alt and ast ≤ 2.5 × uln * alkaline phosphatase (alp) ≤ 5x uln 8. negative response in hiv and syphilis test 9. subject with childbearing potential must agree to abstain from intercourse or use highly effective contraceptives from when signing informed consent to the final/et visit. 10. performance status (ecog) \< 2 11. patients agree to be in compliant to clinical protocol planned treatment plan exclusion criteria: 1. received any other investigational, anti-neoplastic medication (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only), or immune cell therapy within 28 days prior to day 1. 2. currently under immunosuppressive or systemic steroid treatment with equivalent dosage higher than prednisolone 30 mg/day for more than 7 days within 14 days prior to day 1 3. with known tumor metastasis or coexisting malignant disease 4. with ongoing acute diseases, or within the past 2 years having serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. new york heart association grade iii or iv), hepatic (e.g. child-pugh class c), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that, judged by the investigator, could interfere with the results of the trial or adversely affect the safety of the subject 5. known hypersensitivity to aminoglycoside or bacitracin (e.g. streptomycin, gentamicin) 6. known hypersensitivity to any of the components of magicell-nk, including human serum albumin 7. female subject who is lactating or has positive urine pregnancy test at screening
inhaled steroid treatment as regular therapy in early asthma

Conditions: Asthma

Summary: a study of the effect of the early treatment with pulmicort of newly diagnosed asthma. patients will receive either pulmicort or a non-active treatment for three years. neither patients or investigators will be aware of the treatment received. after three years of treatment all patients will receive pulmicort for 2 further years.


Eligibility criteria:
inclusion criteria: * male or female patients aged between 6 and 60 years * diagnosed with asthma within 2 years of starting the study * ability to use a turbuhaler exclusion criteria: * symptoms indicating asthma (e.g. wheezing) for more than two years prior to starting the study * a history of the use of treatments like pulmicort for more than 30 days per year in the two years before starting the study * regular daily treatment for asthma for more than two years before starting the study

Keywords: asthma pulmicort budesonide
study to investigate effects of cal-101 in subjects with allergic rhinitis exposed to allergen in an environmental chamber

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to determine the safety and effect of cal-101 in subjects with allergic rhinitis.

a phase i, randomized, double-blind crossover study of cal-101, an oral inhibitor of phosphatidylinositol 3-kinase (pi3k) delta, in patients with allergic rhinitis.

Eligibility criteria:
inclusion criteria: 1. age \> or = 18 and \< or = 55 years 2. has a history of seasonal allergic rhinitis for at least 2 years 3. has sensitivity to grass pollen demonstrated by a positive response to skin prick testing 4. has a positive radio allergen sorbent test (\> or = class 2) for grass pollen during the previous 12 months or at screening 5. is otherwise healthy, that is, free from clinically significant illness or disease as determined by medical history, physical examination and laboratory tests, including a normal 12-lead electrocardiogram (ecg) 6. has no conditions which would make the subject unlikely to be able to remain in the allergen challenge chamber for 4 hours 7. is available to complete all study procedures 8. is able to provide written informed consent, including compliance with the requirements and restrictions listed in the consent form exclusion criteria: 1. is a female of childbearing potential (non-childbearing potential means documented surgery resulting in infertility or postmenopausal with no menses for at least 1 year) 2. history of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis 3. history of nonallergic rhinitis, chronic sinusitis or severe asthma 4. has a nasal condition likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases 5. is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies, e.g. st. john's wort. paracetamol (\< or = 2g/day) and as needed use of short-acting b2-agonists are allowed. 6. has taken a prohibited medication within the specified interval prior to visit 1: * corticosteroids (depot, 90 days; systemic, 30 days; dermatologic 14 days) * chromones (14 days) * antihistamines (nasal and long-acting oral, 10 days; shorting-acting oral, 2 days; ocular, 3 days) * decongestants (3 days) * leukotriene modifiers (10 days) * anticholinergics (7 days) * opthalmic nonsteroidal * anti-inflammatory drugs (3 days) * nasal-ophthalmic wash solutions (12 hr) * immunotherapy (12 hr) 7. is currently being treated with a medication that induces or inhibits cytochrome p450 (cyp)3a

Keywords: allergic rhinitis allergy phosphatidylinositol 3-kinase
interest of biofer ® compound used in blédilait follow on milk in infant with latent iron deficiency

Conditions: Latent Iron Deficiency

Summary: the primary purpose of the study is to demonstrate the superiority of bledilait milk (biofer® 2mg/100kcal) in comparison with ferrous sulphate supplemented milk (2 mg/100 kcal) in infants (6 to 12 months) with latent iron deficiency by measuring serum ferritin value after 2 months of consumption of studied milks.


Eligibility criteria:
inclusion criteria: * infant between 6 and 12 months of age, * preterm infant, low birth weight infant (\< 2,5 kg), multiple pregnancy, infant from mother with close pregnancies (2 babies in 2 years), * infant with a serum ferritin value \ 11 g/dl), i.e. with a latent iron deficiency, * infant whose parents or legal tutors have given written informed consent, * parents or legal tutors agreeing for 4 month follow-up by the investigator, * infant for which a clinical exam has been performed, * infant with health insurance. exclusion criteria: * infant with serum ferritin value \< 12 ng/ml and haemoglobin value \< 11 g/dl * infant already receiving medicinal iron supplementation, * infant with acquired or congenital defect, * infant presenting a significant metabolic, organic or digestive disease able to interfere with study (including hemochromatosis) * infant with congenital and/or chromosomal malformation * infant receiving a drug susceptible, according to the investigator, to interfere with the measured study parameters * infant needing specific infant formula (hypoallergenic, without cow milk proteins) * infant in a situation that could, according to investigator, interfere with an optimal participation to the study or be a health risk

Keywords: iron deficiency ferritin encapsulated iron infant formula
air2 extension study to demonstrate longer-term (> 1 year) durability of effectiveness

Conditions: Asthma

Summary: the objective of this study is to evaluate durability of effectiveness (beyond one year) of the alair system in patients with severe persistent asthma. the study will consist of alair-group subjects who are currently in the follow-up phase (out to 5 years) of the air2 trial (protocol #04-02, clinicaltrials.gov number nct00231114). durability of the treatment effect will be evaluated by comparing the proportion of subjects who experience severe exacerbations during the first year after alair treatment with the proportion of subjects who experience severe exacerbations during subsequent 12 month periods out to 5 years. all alair group subjects in the air2 trial are being followed out to 5 years as per the air2 trial protocol. the data that are to be used to determine durability of effectiveness as described in the present protocol (protocol #10-01) are being collected under the existing air2 trial protocol (protocol # 04-02). study hypothesis: an empirical demonstration of the durability of the treatment effect will be used to show that the proportion of subjects experiencing severe exacerbations for the first year compared with the proportions of subjects experiencing severe exacerbations in subsequent years do not get substantially worse. the primary statistical objective is to demonstrate that the proportion of subjects who experience severe exacerbations in the subsequent 12-month follow-up (for year 2, year 3, year 4 and year 5 \[in 12-month periods\]) is not statistically worse when compared with the proportion of first 12-months, which begins 6-weeks after the last alair treatment. this objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%.

this will be an open-label, single arm study designed to demonstrate the durability of effectiveness (beyond one year) of the alair system in patients with severe persistent asthma. durability of treatment effect will be evaluated by comparison of the proportion of subjects experiencing severe exacerbations during the first year after the alair treatment to subsequent 12-month periods out to 5 years. the 12-month periods will begin 6 weeks post-last alair bronchoscopy.

Eligibility criteria:
inclusion criteria: * all alair group subjects who have participated in the air2 trial (nct00231114) and were not lost to follow-up at the end of the 12 month premarket visit, and those who are willing to comply with the study protocol and routine visits for the duration of the study will be included in the post-approval study exclusion criteria: * none.
safety, tolerability, and pharmacodynamics of ionis-dgat2rx in adult patients with type 2 diabetes

Conditions: Hepatic Steatosis

Summary: the purpose is to assess the safety, tolerability, and pharmacodynamics effect of ionis dgat2rx in up to 45 adult patients with type 2 diabetes.

this short-term study will assess changes in hepatic steatosis over a 13-week treatment period in a patient population with higher risk for development of nonalcoholic fatty liver disease (nafld) and nonalcoholic steatohepatitis (nash), obese type 2 diabetes mellitus (t2dm) with elevated hba1c.

Eligibility criteria:
inclusion criteria: * must have given written informed consent and be able to comply with all study requirements. * males or females aged 18-75, inclusive, at the time of informed consent. * females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal. * males must be surgically sterile, abstinent or using an acceptable contraceptive method. * body mass index (bmi) ≥ 27.0 - ≤ 39.0 kilograms per square meter (kg/m\^2). * diagnosis of type 2 diabetes mellitus with an hemoglobin a1c (hba1c) ≥7.3% and ≤9.5% at screening. * must have been on a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to screening. * ≥ 10% liver fat prior to randomization assessed by mri-pdff. * stable body weight for at least 3 months before screening. exclusion criteria: * clinically-significant abnormalities in medical history or physical examination. * clinically-significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion, per sponsor. * evidence of uncorrected hypothyroidism or hyperthyroidism results at screening. * history of solid organ transplantation or renal dialysis. * clinically-significant complications of diabetes. * treatment with another study drug, biological agent, or device within one-month of screening. * known history or evidence of liver disease with a positive test for human immunodeficiency virus (hiv), hepatitis c virus (hcv), or chronic hepatitis b virus (hbv), or chronic liver disease other than nash. * recent history of, or current drug or alcohol abuse. * current use of concomitant medications known to significantly impact body weight or that may cause liver toxicity, per investigator * use of anticoagulant/antiplatelet agents unless the dose has been stable for 4 weeks prior to the first dose of study drug\] * use of non-steroidal anti-inflammatory drug nimesulide or any other drug influencing coagulation (except lose-dose aspirin). * use of obeticholic acid or ursodeoxycholic acid * considered unsuitable for inclusion by the principal investigator

Keywords: hepatic steatosis ionis-dgat2rx type 2 diabetes
ct perfusion scans for assessment of lung cancer before and after chemo +/- radiotherapy

Conditions: Non-small Cell Lung Cancer

Summary: cancer of the lung is treated with surgery, radiation or chemotherapy, depending on the stage or extent of the disease. some patients are treated with chemotherapy and/or radiation therapy before surgery to improve the results of surgery. after these treatments, we do not know whether the residual tumour tissue is still alive or dead, which is why some physicians feel that surgery is required to remove it. this study is designed to assess if computed tomography (ct, cat-scan) enhanced with intravenous contrast agent (dye) can characterize a lung cancer, and say whether it is alive or dead. the researchers hope that in the future such a contrast-enhanced cat-scan will make surgery less often necessary or improve the results of chemotherapy and/or radiation given before surgery.

the proposed study will be performed in patients with a proven lung cancer for whom induction therapy and subsequent surgical resection of any kind is planned. kinetic analysis of dynamic contrast-enhanced ct will performed using the ct perfusion 3 software (general electric medical systems), yielding parameters characterizing tumor microvasculature in terms of the vascularity, or the blood volume (bv), the tumor perfusion or blood flow (bf), and the immaturity of the vascular wall, in terms of the microvascular permeability (permeability surface area, ps). to test the assumption that dynamic ct-assessed tumor microvascular characteristics represent reliable, user-independent and reproducible parameters, microvascular values and parameter maps will be derived from two independent observers. to address the interobserver variability, each study will be analyzed by the pi and by a second researcher (blinded to the results of the pi). kappa-statistics will be used to assess inter-rater concordance. to test the hypothesis that the microvascular parameters obtained from dynamic contrast-enhanced ct predict the response to induction therapy, the parameters bv, bf and ps obtained prior to any treatment will be correlated with the histological result from the resected specimen (path cr or path non-cr). spearman correlation will be used to compare non-parametric histology results with quantitative ct microvascular parameters. to test the hypothesis that the microvascular parameters obtained from dynamic contrast-enhanced ct reflect the response to induction therapy, the parameters bv, bf and ps obtained after completion of induction treatment will be correlated with the histological result from the resected specimen (path cr or path non-cr). spearman correlation will be used to compare non-parametric histology results with quantitative ct microvascular parameters.

Eligibility criteria:
inclusion criteria: * diagnosis of non-small cell lung cancer * patients who are scheduled for any neo-adjuvant treatment exclusion criteria: * females who are known to be pregnant or nursing * patients with a history of adverse reaction to previous contrast agent administration * patients with known renal disease

Keywords: perfusion ct cat non-small lung
sofosbuvir containing regimens for the treatment of chronic hcv gt3 infected patients

Conditions: Chronic Hepatitis C Infection

Summary: the purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with hcv genotype 3 infection.


Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years, with chronic genotype 3 hcv infection; * documented hcv treatment-naïve or treatment-experienced subjects who failed previous peg+rbv regimen; * hcv rna \> 10,000 iu/ml at screening; * screening laboratory values within defined thresholds; * negative pregnancy test at baseline (females of childbearing potential only); * use of two effective contraception methods if female of childbearing potential or sexually active male. exclusion criteria: * pregnant or nursing female; * hiv infection or hbv infection (hbcab and hbsag positive); * hematologic or biochemical parameters at screening outside the protocol-specified requirements; * active or recent history (≤ 1 year) of drug or alcohol abuse; * hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).
antibody response against sars-cov-2 in dialysis patients during covid-19

Conditions: COVID; Terminal Renal Insufficiency

Summary: determination of igm and igg antibodies against sars-cov-2 in dialysis patients by continous monitoring in the period from march 2020 to december 2020

blood samples are collected every 14 days

Eligibility criteria:
inclusion criteria: * dialysis exclusion criteria: * not willing to give consent

Keywords: covid-19 ckd 5
tailored therapy for hodgkin lymphoma using early interim therapy pet for therapy decision.

Conditions: Hodgkin Lymphoma

Summary: recently published studies demonstrated very high event free survival for patients with a normal interim pet/ct and a high hazard ratio for progression of an interim positive (pathological)study. these findings strongly support the integration of interim pet as a decision point for adjustment of chemotherapy.this study use the minimal therapy considered safe according to the predefined risk factors for patients with interim negative pet. those with pathologic interim study considered as higher risk patients will have dose escalation of therapy.remission rate ,event free survival and overall survival will be evaluated.

study aim is to tailor the therapy in order to administer the lowest cumulative dose of therapy yet considered safe in order to reduce both early and late therapy related complications. patients will be divided according to risk factors to sub groups of early favorable, early unfavorable, advanced disease with score less then 3 points or higher then 3 points. early interim pet will be carried out further therapy will be based on the study results.

Eligibility criteria:
inclusion criteria: * hodgkin lymphoma patients * age 18-60 for those with early disease and advanced disease with score less then 3 * age 18-60 years for patients with advanced disease score 3 or higher classical hodgkin lymphoma * wbc more then 3500 * platelets more then 100000 * creatinin less then 2.0 mg * bilirubin less then 2.0 mg * absolute neutrophil count more then 1000 unless bone marrow involvement if marrow involve, patient with lower count but anc of 1000 may be included. exclusion criteria: * positive serology for hiv * bilirubin more then 2 mg/dl * creatinin more then 2 mg/dl * lactating woman or pregnant * patient older then 60 years with high risk disease of score 3 or more

Keywords: hodgkin lymphoma pet/ct therapy
pvi for prediction of spinal induced hypotension

Conditions: Spinal Induced Hypotension

Summary: the hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery


Eligibility criteria:
inclusion criteria: * english speaking asa i-ii non-laboring women with single gestations ≥36 weeks * scheduled or unscheduled cesarean delivery under spinal anesthesia * height: 5 feet-5 feet 11 in. exclusion criteria: * laboring women needing an emergency cesarean delivery * severe hypertensive disease of pregnancy defined as systolic blood pressure (sbp)\>160mmhg, diastolic blood pressure (dbp)\>110mmhg requiring antihypertensive treatment or associated with significant proteinuria. * severe cardiac disease in pregnancy with marked functional limitations * diabetes type i * patients on monoamine oxidase inhibitors or tricyclic antidepressants * inclusion in another anesthetic study involving drug administration.