Kornimate/medical-research-clean huggingface dataset:
pnu-100480 in newly diagnosed, drug sensitive patients with pulmonary tb; early bactericidal activity; whole blood assay

Conditions: Tuberculosis

Summary: pnu-100480 is being developed for the treatment of both drug resistant and sensitive tuberculosis. this is an efficacy and safety study to characterize the effect of pnu-100480 when given for 14 days to treatment-naive patients with drug-sensitive pulmonary tuberculosis.


Eligibility criteria:
inclusion criteria: * adult males or females between 18 and 65 years; women of childbearing potential must be willing to adhere to lifestyle requirements regarding contraception/pregnancy prevention. * newly diagnosed sputum smear-positive pulmonary tb confirmed with acid-fast bacillus (afb) smear and chest x-ray. patients with tb more than 5 years ago who completed treatment, are healthy, and meet other inclusion criteria may be included. * body weight between 40 and 90 kg, inclusive (in light clothing, no shoes). * reasonably normal hemoglobin (\>=8 gm/dl), renal function (serum creatinine \<2 mg/dl), hepatic function (serum ast \<3xuln and total bilirubin \<1.3 mg/dl), and random glucose \<150 mg/dl. exclusion criteria: * hiv infection with helper/inducer t-lymphocytes (cd4 cell) count of \<=350x10-6/l. * presence of significant hemoptysis. subjects who cough up frank blood (more than blood streaked sputum) will not be eligible. * pregnant or nursing females; females of childbearing potential unwilling or unable to adhere to contraception guidelines. * significant respiratory impairment (respiratory rate \>35/minute). * clinical suspicion of disseminated tb or tuberculosis meningitis. * subjects with diabetes mellitus on insulin and/or who have poorly controlled disease. * subjects with confirmed or suspected multi-drug resistant tb.

Keywords: tuberculosis eba wba
a phase ii study to evaluate the efficacy and the safety of flumatinib in cml-ap or cml-bp patients

Conditions: Chronic Myelogenous Leukemia

Summary: multi-center, single stage, phase ii study to evaluate the efficacy and safety of flumatinib in accelerated or blastic phase chronic myelogenous leukemia patients.

multi-center, single-arm, open-label,phase ii study to investigate efficacy and safety of flumatinib in chinese patients with accelerated or blastic phase chronic myelogenous leukemia. the starting daily oral dose of flumatinib is 600mg，core test is six cycles (each cycle is 28 days), collecting the core test data for primary efficacy analysis. the longest treatment time is 12 cycles.

Eligibility criteria:
inclusion criteria: * male or female patients age 18-75 year-old; * ecog 0 - 2; * newly diagnosed or previously treated ph+ cml patients in accelerated or blastic phase; * adequate organ function; * written informed consent prior to any study procedures being performed. exclusion criteria: * patients in chronic and blastic phases; * previously treated with flumatinib; * previously documented t315i mutations; * previous therapy within protocol defined timeframe, including: * hydroxyurea within 24 hr, * imatinib or nilotinib or dasatinib within 28 days) * cardiac dysfunction ; * history of congenital or acquired bleeding disorders unrelated to cml; * central nervous system leukemia; * previous malignancy except cml; * acute or chronic liver or severe kidney disease unrelated to cml; * pregnant, breastfeeding, child bearing potential but failed to take effective contraception.
impact of early enteral vs. parenteral nutrition on preservation of gut mucosa integrity in patients requiring mechanical ventilation and catecholamine

Conditions: Acute Respiratory Failure; Shock

Summary: to demonstrate that a strategy involving early first-line enteral nutrition is associated with improved preservation of gut mucosa integrity, as assessed based on the plasma citrulline level at h72, compared to a strategy involving early first-line parenteral nutrition

published data suggest that enteral nutrition may be associated with improved preservation of the gut lymphoid tissues and gut immune function, as well as with decreased gut mucosa permeability, thereby diminishing the risk of organ failure. citrulline is an amino acid produced from glutamine by small-bowel enterocytes. plasma citrulline levels reflect functional enterocyte mass. intestinal fatty acid-binding protein (i-fabp, also known as fabp2) is a small protein found in the cytosol of small-bowel enterocytes. plasma i-fabp is normally undetectable and, when elevated, constitutes a reliable marker for enterocyte damage. the hypothesis underlying this ancillary study is that first-line enteral nutrition is associated with improved gut mucosa integrity and function compared to parenteral nutrition.

Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation expected to be required more than 48 hours * nutrition started within 24 hours after initiation of endotracheal mechanical ventilation * treatment with vasoactive drug administered via a central venous catheter * age over 18 years * signed information exclusion criteria: * abdominal surgery within 1 month before inclusion * history of esophageal, gastric, duodenal or pancreatic surgery * bleeding from the esophagus, stomach or bowel * enteral nutrition via gastrostomy or jejunostomy * pregnancy * treatment-limitation decisions * current inclusion in a trial on comparison between enteral and parenteral nutrition

Keywords: vasoactive drug mechanical ventilation early enteral nutrition intensive care unit early parenteral nutrition critical care medicine nosocomial infection mortality shock
sensitivity of frequent sars-cov-2 (covid-19) rapid antigen testing regimen

Conditions: Covid19

Summary: this study aims to assess how an at-home covid-19 frequent testing regimen using the cov-scan test kit and a paired phone application to help interpret the test result compares to once-a-week or three-times-a-week polymerase chain reaction (pcr) (molecular) testing to identify a sars-cov-2 infection. employees and cast members at media and entertainment company and its affiliates will be recruited to test whether frequent use of cov-scan will perform as well or better than weekly molecular testing and at least as well as three-times-a-week molecular testing.

antigen tests are simple to perform, have a rapid turn-around time of 15-30 minutes, and a lower cost than molecular tests. because antigen tests do not incorporate an amplification step, they are intrinsically less sensitive than pcr molecular tests. nevertheless, several investigators have examined the feasibility of screening populations of individuals in a low sars-cov-2 infection prevalence situation, such as the workplace or schools, with rapid antigen tests in place of the molecular tests. using viral kinetics, knowledge of what level of viral load is required for transmission of culture-competent virus, test sensitivity and modeling, they have come to the conclusion that more frequent testing with a test with lower sensitivity that has a quick turn-around time is better than a test with high sensitivity with a longer turn-around time. therefore, the goal of this study is to test the hypothesis that frequent testing with a relatively sensitive lateral flow antigen test performed at home using self-collected anterior nasal swabs will be superior to once a week or less pcr testing and non-inferior to three times a week pcr testing in an employment screening setting with a relatively low incidence of new sars-cov-2 infections. this study aims to assess how an at-home covid-19 frequent testing regimen using a rapid antigen screening test (rast) and a phone application to help interpret the test result compares to once-a-week or three-times-a-week pcr (molecular) testing to identify a sars-cov-2 infection. we expect to recruit up to 4,400 employees and cast members of media and entertainment company and its affiliates to test whether frequent use of the rast will perform as well or better than weekly molecular testing and at least as well as three-times-a-week molecular testing. recruitment and the study will continue until at least 31 or at most 148 true positive sars-cov-2 molecular results are reached.

Eligibility criteria:
inclusion criteria: * aged 18 years or older; * have a smartphone; * understand and read english; * will be on one production location for at least three weeks following enrollment to the study; * will be willing to be contacted by the study coordinator after leaving one production location to facilitate continued access to weekly molecular testing; exclusion criteria: * have received any dose of covid-19 vaccination; * have been diagnosed with covid-19 infection.

Keywords: covid-19 covid coronavirus sars-cov-2
the drug-drug interaction study of aju-a51r1 and aju-a51r2

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: to evaluate a pharmacokinetic drug interaction between aju-a51r1 and aju-a51r2 in healthy male volunteers.

this study is to investigate drug-drug interaction between aju-a51r1 and aju-a51r2.

Eligibility criteria:
inclusion criteria: 1. individuals whose age is over 19 and under 65 years old when visiting for initial screening test. 2. body mass index(bmi) between 17.5\~30.5 kg/m\^2 and the body weight must be over 55 kg(men) or 45 kg(women) (body mass index (bmi) = weight (kg) / height (m)\^2) . 3. individuals with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area. 4. due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ecg), and etc. 5. the participants must be volunteered and sign in an informed consent document proven by chonbuk national university irb before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs. 6. individuals who agreed proper contraception during the study 7. the participants must have an ability and willingness to participate throughout the entire trials. exclusion criteria: 1. individuals with a medical evidence or a history (excluding dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease. 2. individual who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or crohn's disease) or surgeries (except a simple appendectomy or herniotomy). 3. individual who had following results after examination(a. alt or ast \> twice higher than upper limit of normal value). 4. individual who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 ml) = 10 g, a shot of soju (20%) (50ml) = 8 g, a glass of wine (12%) (125 ml) = 12g). 5. individual whose blood pressure \< 90 or ≥160(systolic blood pressure) or \< 50 or ≥ 100(diastolic blood pressure). 6. individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within 180 days prior to the first dose of this study(except when subject have not taken investigational product(s)). 7. individual who had a medical history of alcohol and drug abuses. 8. individual who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing drug. 9. individual who has galactose intolerance, lapp lactose intolerance, glucose-galactose malabsorption or genetic disorders. 10. a person who is not determined unsuitable to participate in this test by the researchers.
total contact insole for chronic nonspecific low back pain (lbp)

Conditions: Chronic Nonspecific Low Back Pain

Summary: non-specific low back pain is a common condition. insoles are one of the many treatment form for chronic nonspecific lbp. the investigators hypothesized the contact total insole group will present pain reduction and functional improvement. the aim of this study is to assess the effectiveness of contact total insole for people with nonspecific chronic low back pain and the impact of this insole on function, quality of life, load distribution in the plantar region, gait variables and satisfaction with insole use.

a randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. eighty-four patients with nonspecific chronic low back pain will be randomly into a study group and control group. one week following the baseline evaluation, the study group will receive a contact total insole made of ethyl vinyl acetate and the control group will receive a flat insole made of the same material, color and density. the groups will be evaluated after 6, 12 and 24 weeks of insole use. the following assessment parameters will be employed: low back pain numerical pain scale; functional capacity (oswestry and roland morris questionnaire, six minute walk test and timed to up and go test); quality of life (short form-36) and foot pressure analysis using the amcube footwalk pro program.

Eligibility criteria:
inclusion criteria: * low back pain for more than 3 months, with numeric pain scale between 3 - 8 cm; * over 18 years; * no distinction of sex; * understand portuguese well enough to be able to fill in the questionnaires; * agree to participate of the study and sign the informed consent form. exclusion criteria: * inflammatory/rheumatological diseases, tumor, infection or vertebral fracture; * litigation; * fibromyalgia; * other symptomatic musculoskeletal diseases in lower limbs; * symptomatic diseases of the central and peripheral nervous system; * diabetes mellitus; * rigid deformities on foot; * use of insoles in the last three months; * medical or physiotherapeutic treatment for low back pain or any problem in lower limbs in the last three months; * people who had changed physical activity or undergone physical therapy in the previous 3 months; * pregnancy; * difference of lower limbs greater than 2 cm * less than 6 months after lumbar spine, lower limb or abdomen surgery * previous spinal surgery; * previous spinal infiltration for pain relief in the last 3 months; * serious scoliosis; * allergy to the material of the insole. * planned travel in the next 12 weeks; * geographic inaccessibility.

Keywords: orthotic devices insoles quality of life function
impact of a pluriprofessional intervention to improve medication adherence (secondary preventive medication) in patients after ischemic stroke

Conditions: Ischemic Stroke

Summary: medication adherence is a major factor to prevent vascular recurrence after a first ischemic stroke. nevertheless, it is suboptimal and the implementation of specific interventions are needed to improve it. a patient - centered and pluriprofessional structured intervention, targeting the medication, introduced at hospital discharge and continued at home (by regular telephone contact) could improve medication adherence one year after stroke. this intervention would consist of semi structured interviews patient-pharmacist at different times during one year after stroke. the information about the therapeutic management of the patient will be shared between healthcare professionals : general practitioners (gp) and community pharmacists (cp), hospital clinical pharmacist (hcp) and physician (hphys). it will allow for decrease of the recurrent stroke and others cardiovascular complications based on a better adherence to preventive medication. furthermore the decrease of the iatrogenic events and the improvement of the quality of life of patients may be also associated.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * patient with ischemic stroke hospitalized in physical medicine and rehabilitation unit or neurovascular unit * return at home at the hospital discharge * medication including an antiplatelet drug or an oral anticoagulant with at least an antihypertensive drug and/or a lipid lowering agent (statin) * patient without either cognitive disorders or major psychiatric disorders * patient with a sufficient autonomy for the management of medication at home (score of barthel \> 30) exclusion criteria: * patient ≤ 18 years * patient with important cognitive or psychiatric disorders * management of patient medication exclusively by the helper * no usual pharmacy (or more than 2 usual pharmacies) * patient directed to an institution at the end of the hospitalization

Keywords: ischemic stroke medication adherence cardiovascular disease prevention
an observational study of the use and safety of raptiva during pregnancy (follow)

Conditions: Psoriasis; Pregnancy

Summary: the raptiva pregnancy registry was a prospective observational study established to obtain data on pregnancy outcomes of women who were exposed to raptiva.


Eligibility criteria:
any patient who has used raptiva within 6 weeks prior to conception or during her pregnancy may be included in the registry. enrollment is based on raptiva exposure, whether inadvertent or deliberate, in relation to pregnancy. enrollment should occur as early as possible during the pregnancy and must occur prior to knowledge of pregnancy outcome.

Keywords: follow psoriasis pregnancy
cataract refractive suite study

Conditions: Cataracts

Summary: the purpose of this study is to compare the refractive predictability (prediction error) between the cataract refractive suite (crs) and standard manual technique at one month post-operative


Eligibility criteria:
inclusion criteria: * diagnosed with bilateral cataracts; * planned cataract surgery and implantation of restor +2.5 d multifocal intraocular lens (iol) in both eyes; * clear intraocular media, other than cataract, in study eye(s); * willing and able to complete all required postoperative visits; * able to comprehend and sign a statement of informed consent; * other protocol-specified inclusion criteria may apply. exclusion criteria: * significant irregular corneal astigmatism; * history of or current severe dry eyes, retinal/uveal pathology or concurrent ocular disease; * previous intraocular or corneal refractive surgery, corneal transplant, or retinal detachment; * any inflammation or edema (swelling) of the cornea; * pregnant; * other protocol-specified exclusion criteria may apply.
study safety and efficacy of bmmnc for the patient with duchenne muscular dystrophy

Conditions: Muscular Dystrophy; Duchenne Muscular Dystrophy

Summary: this study is single arm, single center trial to check the safety and efficacy of bmmnc (100 million per dose) for the patient with duchenne muscular dystrophy,

muscular dystrophies, or md, are a group of inherited conditions, which means they are passed down through families. they may occur in childhood or adulthood. there are many different types of muscular dystrophy. they include: duchenne muscular dystrophy is a form of muscular dystrophy that worsens quickly. other muscular dystrophy (including becker's muscular dystrophy) get worse much more slowly. duchenne muscular dystrophy is caused by a defective gene for dystrophin (a protein in the muscles). however, it often occurs in people without a known family history of the condition. symptoms usually appear before age 6 and may appear as early as infancy. they may include: fatigue learning difficulties (the iq (intelligence quotient )can be below 75) intellectual disability (possible, but does not get worse over time) muscle weakness begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body difficulty with motor skills (running, hopping, jumping) frequent falls trouble getting up from a lying position or climbing stairs weakness quickly gets worse progressive difficulty walking ability to walk may be lost by age 12, and the child will have to use a wheelchair breathing difficulties and heart disease usually start by age 20

Eligibility criteria:
inclusion criteria: * patient with diagnose of duchenne muscular dystrophy. * aged in between 4 to 20 years. * willingness to undergo bone marrow derived autologous cell therapy. * ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required informed consent form(icf) for the study. * ability and willingness to regular visit to hospital for protocol procedures and follow up exclusion criteria: * patient with history of immunodeficiency hiv+,hepatitis b ,hbv and tppa+, tumor markers+ * patients with history of hypertension and hypersensitive. * patient who is not diagnose of duchenne muscular dystrophy. * alcohol and drug abuse / dependence.

Keywords: duchenne muscular dystrophy muscular dystrophy myopathy
relation of caries color to caries severity and its microbial load

Conditions: Relation of Caries Color

Summary: this study is to find the relation of caries color to caries severity and its microbial load in primary molars.

this study is to investigate the relationship between the caries color to caries severity and its microbial load.

Eligibility criteria:
inclusion criteria: 1. their ages ranged from (4 to 7) years. 2. they were healthy, free from any chronic disease and had no previous anxiety disorder or medical disability such as the history of seizures or convulsion disorders, nystagmus, vertigo or equilibrium disorders, eye problems and autism. 3. primary molars with class 1 caries, normal furcation and normal periapical bone structure 4. they were indicated for restorative treatment under local anesthesia. 5. they were not indicated for pharmacological management exclusion criteria: 1. primary molars with class 2 caries 2. teeth with mobility 3. periapical abscess 4. fistula

Keywords: relation of caries color history of pain caries severity icdas microbial load radiograph