Kornimate/medical-research-clean huggingface dataset:
efficacy safety study of arformoterol qd dosing versus bid dosing in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4ml qd (two 15μg/2ml dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 ml bid in subjects with copd.

this is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg bid versus arformoterol 30μg qd in subjects with copd. subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call. this study was previously posted by sepracor inc. in october 2009, sepracor inc. was acquired by dainippon sumitomo pharma., and in october 2010, sepracor inc's name was changed to sunovion pharmaceuticals inc.

Eligibility criteria:
inclusion criteria: * male and female subjects must be at least 45 years old at the time of consent. * subjects must have a pre-established primary clinical diagnosis of copd. * subjects must have a baseline fev1 of ≤ 65% of predicted normal value at visit 1. * subjects must have a fev1 ≥ 0.70l at visit 1. * subjects must have a fev1/forced vital capacity (fvc) ratio of ≤ 70% at visit 1. exclusion criteria: * subjects who do not have a 15 pack-year smoking history and a baseline breathlessness severity grade of 2 (as measured by the modified medical research council \[mmrc\] dyspnea scale score) at screening. * subjects with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to visit

Keywords: copd chronic bronchitis emphysema
study of natalizumab in relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the primary objectives of the study are to evaluate the safety profile and the anti-tumor activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple myeloma. secondary objectives are to assess the pharmacokinetic (pk) profile of natalizumab in this study population and to assess peripheral blood mononuclear cell (pbmc) saturation of very late antigen-4 (vla-4, an α4-integrin) and evaluate possible correlations with clinical activity.

despite no protocol-defined study stopping criteria being met, the sponsor decided to terminate enrollment after the phase 1 portion was complete and to not move into the phase 2 portion of the study. this decision was made due to difficulty enrolling participants and was not due to any safety concerns.

Eligibility criteria:
key inclusion criteria: * relapsed or refractory multiple myeloma that was treated with or was considered inappropriate for treatment with bortezomib and an imid® drug (including an analogue). * eastern cooperative oncology group (ecog) performance status ≤2. * corrected calcium \<10.6 mg/dl. key exclusion criteria: * candidates for stem cell transplantation willing to undergo transplantation. (subjects who are candidates for stem cell transplantation, but are not willing to undergo transplant will be eligible for the study.) * autologous stem cell transplantation \<3 months post-transplant. * prior allogeneic stem cell transplantation. * nonsecretory myeloma. * plasma cell leukemia (\>2000/µl circulating plasma cells by standard cell counting differential), hyperleukocytosis (white blood cells \>100,000/µl), clinical evidence of hyperviscosity syndrome, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (poems), or primary systemic amyloidosis. * subjects who cannot undergo a brain magnetic resonance imaging (mri) study. * clinically significant (as determined by the investigator) 12 lead electrocardiogram (ecg) abnormalities, including qtc prolongation (\>450 ms in males, \>470 ms in females). note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: relapsed or refractory multiple myeloma
bypass surgery versus everolimus-eluting stent implantation for multivessel coronary artery disease (best)

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine whether the safety and efficacy of coronary stent implantation using everolimus-eluting coronary stent system (abbott, boston scientific) is not inferior to coronary artery bypass grafting (cabg) for the treatment of patient with multivessel coronary artery disease (cad).

the primary purpose of the best study is to determine whether the safety and efficacy of coronary stent implantation using everolimus-eluting balloon expandable stents is not inferior to coronary artery bypass grafting for the treatment of multivessel coronary artery disease.

Eligibility criteria:
inclusion criteria: * age 18 years of older * angiographically confirmed multivessel cad \[critical (\>70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (lad, lcx, rca)\] and amenable to either pci or cabg. * indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia * geographically accessible and willing to come in for required study visits * signed informed consent. exclusion criteria: * severe congestive heart failure (class iii or iv according to nyha, or pulmonary edema) at the time of enrollment. * planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent). * in-stent restenosis of a target vessel * prior cabg surgery * prior pci with stent implantation within 1 year * two or more chronic total occlusions in major coronary territories * acute st-elevation mi(q-wave) within 72 hours prior to enrollment requiring revascularization * abnormal creatine kinase (ck \> 2x normal) and/or abnormal ck-mb levels and/or elevated troponin levels at time of randomization * previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a rankin score \> 1 * dementia with a mini mental status examination (mmse) score of ≤ 20 * extra-cardiac illness that is expected to limit survival to less than 2 years; e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease. * prior history of significant bleeding (within the previous 6 months) that might be expected to occur during cabg or pci/des related anticoagulation. * contraindication either cabg or pci/des because of a coexisting clinical condition * significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis * intolerance or contraindication to aspirin or both clopidogrel and ticlopidine * suspected pregnancy. a pregnancy test (urine or serum) will be administered prerandomization to all women not clearly menopausal * concurrent enrollment in another clinical trial

Keywords: coronary artery disease stent coronary artery bypass graft surgery multivessel coronary artery disease
clinical study of nk cells in the treatment of severe endometriosis

Conditions: NK Cell Mediated Immunity; Endometriosis

Summary: dysfunction of natural koller cells (nk cells) is an important factor in the development of endometriosis. nk cell therapy was applied to treat severe endometriosis, which is an exploration of the pathogenesis of this refractory disease.

endometriosis (ems) is one of the common and frequently occurring diseases in women of childbearing age, which seriously affects the health and quality of life of the vast majority of women. the pathogenesis of endometriosis is unknown until now, and the recurrence rate of existing treatment methods is high. it is more and more necessary to introduce new therapeutic methods and strategies in view of the mechanism associated with the reduction of natural killer cell (nk) cytotoxicity. in this study, routine therapy combined with nk cell therapy was used in the treatment of severe endometriosis. the clinical data were collected to confirm the efficacy and safety of nk cell therapy. it is expected to provide a new way of thinking and method for the clinical treatment of ems.

Eligibility criteria:
inclusion criteria: 1. diagonsed as endometriosis stage iii\~iv 2. age ≥18 years ≤ 45 years at the time of informed consent 3. with indications for conservative endometriosis surgery 4. with complete clinical data exclusion criteria: 1. severe allergy to drugs 2. patients with abnormal immune status (autoimmune disease or long-term use of immunosuppressive agents) 3. with serious cardiac, cerebrovascular diseases and liver, kidney disorders 4. with a history of severe mental illness

Keywords: endometriosis nk cell therapy
liver function abnormalities in patients with acute heart failure

Conditions: Acute Heart Failure

Summary: the aim of this study is to evaluate liver function test abnormalities and to identify associated cardiac and non cardiac factors mediating hepatic impairment in acute heart failure patients

cardiac failure has a negative impact on the function of all parenchymatous organs, based both on the low organ perfusion in the left-sided failure and on the venous congestion in the right-sided failure. the pathophysiology of acute heart failure (ahf) is complex and not fully understood. it has been hypothesized that an episode of acute decompensation affects not only the cardiovascular system itself, but may also deteriorate the function of other organs, c ausing serious clinical consequences. liver involvement has been mostly described and investigated in patients with chronic hf. liver enzyme alterations are usually classified as relating predominantly to liver cell necrosis (signified by transaminase elevations) or predominantly to cholestasis (signified by elevated alkaline phosphatase (ap) level).

Eligibility criteria:
inclusion criteria: * patients aged 18 yrs or older presenting with ahf exclusion criteria: * congenital heart disease * acute and chronic liver diseases

Keywords: lfts, ahf
comparison of the qt/qtc interval between an outpatient hiv-infected population on antiretroviral therapy and two large hiv-negative cohorts

Conditions: QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen

Summary: this is a unicentric, two cohorts, observational transversal study. the purpose of this study is to compare the qt/qtc intervals of hiv positive subjects receiving an antiretroviral therapy and those without hiv in an ambulatory care setting.

primary objective: the primary objective is to compare the qt/qtc intervals of hiv positive subjects treated with antiretroviral therapy and followed at the ambulatory hiv clinic and the qt/qtc intervals of : 1. an outpatient hiv negative population from the same health center pre-admission one-day surgical clinic. 2. the large hiv-free korean population studied in the ecg-view database. secondary objectives : * evaluate the prevalence of qtc interval prolongation in the outpatient hiv positive population comparatively to the two hiv negative outpatient populations available from the one-day surgical clinic and the ecg-view database. * evaluate risk factors associated with qtc interval prolongation in the outpatient hiv positive population compared to the outpatient hiv negative population and the population studied in the ecg-view database. * compare the qt/qtc intervals and the prevalence of qtc interval prolongation of the outpatient hiv positive population currently on an antiretroviral regimen including a protease inhibitor versus those on an antiretroviral regimen without protease inhibitor. * compare the qt/qtc intervals among the outpatient hiv positive population treated with a protease inhibitor, in regard to the presence or the absence of certain genetic polymorphisms that may influence pharmacokinetic aspects of protease inhibitors.

Eligibility criteria:
inclusion criteria: * age eligible for study : 18-65 years old inclusively * gender eligible for study : both exclusion criteria: * hospitalised at the moment of recruitment * aids status o opportunistic infections acquired in the last 30 days before the date of recruitment * age \ 65 years old * follow-up care in an oncology clinic * dialysis during the study period * pregnancy * without antiretroviral therapy * history of a myocardial infarction in the 3 weeks preceding recruitment * have a pacemaker * diagnosed with bundle branch block on ecg * principal follow-up care outside of the chum hiv clinic * refusal to participate in the study
a study of atra in the treatment of itp

Conditions: Immune Thrombocytopenia

Summary: an open-label, multicenter study to compare the efficacy and safety of atra for the treatment of adults with primary immune thrombocytopenia (itp)

the investigators are undertaking an open-label, single-arm, multicenter trial of adults patients with itp in china. patients with treatmant naive itp were given atra treatment. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: 1. confirmed newly-diagnosed, treatment-naive itp; 2. platelet counts \<30×109/l ; 3. platelet counts \< 50×109/l and significant bleeding symptoms (who bleeding scale 2 or above); 4. willing and able to sign written informed consent. exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit; 2. received first-line and second-line itp-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit; 3. received high-dose steroids or ivig in the 3 weeks prior to the start of the study. 4. current hiv infection or hepatitis b virus or hepatitis c virus infections; 5. severe medical condition (lung, hepatic or renal disorder) other than chronic itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia); 6. female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; 7. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test; 8. patients who are deemed unsuitable for the study by the investigator.
a poc and dose-ranging study of htd1801 in psc patients

Conditions: Primary Sclerosing Cholangitis (PSC)

Summary: the study was a dose-ranging, 18-week study comparing two doses of htd1801 (500 mg bid and 1000 mg bid) to placebo in adult subjects with psc.


Eligibility criteria:
inclusion criteria: * male or female between 18 and 75 years of age; * have a clinical diagnosis of psc as evident by chronic cholestasis of more than six months duration with either a consistent magnetic resonance cholangiopancreatography (mrcp)/endoscopic retrograde cholangiopancreatography (ercp) showing sclerosing cholangitis; * if subjects have inflammatory bowel disease (ibd) they will be eligible to participate. if a subject has ibd, documented evidence of ibd must have been evident by prior endoscopy or in previous medical records for ≥6 months. in addition, subjects may only enter the study with a partial mayo score of 0-4, inclusively. subjects who are on treatment are allowed, provided they are stable for 3 months if taking: 1. 5-amino salicylic acid drugs, 2. azathioprine, 3. 6-mercaptopurine, or methotrexate 4. biologics; * have a serum alp ≥1.5 × upper limit of normal (uln); * be able to understand and sign a written informed consent form (icf); * subjects receiving allowed concomitant medications need to be on stable therapy for 28 days prior to the baseline visit, with the exception of ursodeoxycholic acid (udca), which should be stable for at least 6 weeks prior to the baseline visit. exclusion criteria: * presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis, recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis, surgical or blunt abdominal trauma, recurrent pyogenic cholangitis, choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other cause of secondary sclerosing cholangitis) on prior clinical investigations; * small duct psc; * presence of percutaneous drain or bile duct stent; * history of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1 year by mrcp/ercp. presence of dominant stricture without ercp evidence of cholangiocarcinoma is acceptable if stable for ≥ 1 year; * ascending cholangitis within 60 days prior to screening; * history of alcohol or substance abuse or dependence; * prior or planned liver transplantation; * presence of alternative causes of chronic liver disease, including alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, autoimmune hepatitis; * platelet count below 125,000/mm3, albumin below 3.0 g/dl, international normalized ratio (inr) \> 1.2, or a history of ascites, or encephalopathy, or history of esophageal variceal bleeding; * severe active ibd or flare in colitis activity within the last 90 days requiring intensification of therapy beyond baseline treatment;
study of naproxen capsules to treat dental pain

Conditions: Dental Pain

Summary: the purpose of the study is to determine whether naproxen test formulation capsules are safe and effective for the treatment of dental pain.


Eligibility criteria:
inclusion criteria: * patient is male or female between 18 and 50 years of age * for women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control * patient requires extraction of 2 or more third molars * patient must be willing to stay at the study site overnight exclusion criteria: * patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs * patient has a current disease or history of a disease that will impact the study or the patient's well-being * patient has used or intends to use any of the medications that are prohibited by the protocol * patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test * patient has taken another investigational drug within 30 days prior to screening
impact of life-size growth charts on understanding of stunting

Conditions: Stunting

Summary: randomized control trial testing whether exposure to a wall hanging (growth mat) enabling parents to physically compare their children's height against the world health organization (who) standards for height-for-age in combination with normal messaging on stunting increases parents' understanding and retention of those messages. both intervention and control groups will receive messages about stunting over a 3-month period, but the intervention group will also be exposed to the growth mats during the 3-month intervention period. parents in both groups will be tested post intervention on the messages about stunting and scores will be compared.

this study is embedded within a development program implemented by a consortium led by catholic relief services. the program aims to improve child nutrition, in part, through behavior change messaging. parents have difficulty understanding that stunting is a problem because the high prevalence (57%) means the entire population curve has shifted to the left - a stunted child appears normal when compared to others in the community. through previous work, we have designed a wall-hanging like a life-size, color coded growth chart. using 2 stage sampling, with parents clustered in neighbor groups, neighbor groups have been randomly assigned to intervention or control. both groups will receive standard lessons on stunting while only the intervention group will have the growth mats incorporated into the lessons. after 3 months of exposure to the lessons, parents will be tested on their understanding of the key lesson points. scores between groups will be tested for statistical differences. qualitative focus groups throughout the intervention period will collect information on perception of the message delivery and the utility of the growth mats.

Eligibility criteria:
inclusion criteria: * membership and regular participation in the selected neighbor groups exclusion criteria: * extended absence from the village during the intervention period

Keywords: stunting height-for-age behavior change malnutrition
effectiveness study of zymar versus vigamox for preoperative sterilization of the ocular surface after loading dose

Conditions: Eye Infection; Infection

Summary: the purpose of this study is to analyze the effect of zymar and vigamox on ocular surface bacteria. we believe that zymar will eradicate more ocular surface bacteria than vigamox.

topical antibiotics are frequently used before surgical procedures with the intent of targetting and reducing the number of bacteria on the surface of the eye. these bacteria serve as potential sources for post-operative infection. one commonly used method is the administration of antibiotic drops 3 times: 1 hour prior to surgery at intervals of 5 minutes. studies in the lab have shown that the preservative benzalkonium chloride 0.005%, part of the zymar antibiotic drop preparation, allows the antibiotic to act more effectively than the antibiotic vigamox, which does not include this preservative. comparison: the effect of zymar antibiotic eye drops on conjunctival cultures compared to the effect of vigamox on conjunctival cultures as measured by conjunctival cultures taken prior to treatment and then one hour after administration of eye drops 3 times, at 5 minute intervals.

Eligibility criteria:
inclusion criteria: * male or female 25 years of age or older * informed consent * likely to complete the entire course of the study exclusion criteria: * contraindications or known sensitivity to any component of the study medications * a subject on oral or topical antibiotics * a subject that has a condition (i.e. an uncontrolled systemic disease) or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound the trial results, or may interfere significantly with the subject's participation in the trial. * monocular subjects * contact lens wearers * subjects who regularly take eyedrops other than preservative free artificial tears * a subject with an eye infection

Keywords: antibiotic prophylaxis vigamox moxifloxacin zymar gatifloxacin preoperative antibiotic eye infection
safety and immunogenicity of an adjuvanted influenza vaccine in subjects aged 65 years and over.

Conditions: Influenza

Summary: the purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (im) injection of an adjuvanted influenza vaccine in elderly subjects.


Eligibility criteria:
inclusion criteria: * 65 years of age or older and in good health exclusion criteria: * any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (copd) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure. * any acute disease or infections requiring systemic antibiotic or antiviral therapy * hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine * history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine * known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days

Keywords: influenza elderly vaccine