Kornimate/medical-research-clean huggingface dataset:
evaluation of efficacy and safety of formoterol in patients with copd compared with placebo in patients in japan, eu

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with copd compared with placebo in patients in japan and in european countries during 12 weeks.


Eligibility criteria:
inclusion criteria: * males or females aged above 40 with a clinical diagnosis of copd and current copd symptoms * current or previous smoker with a smoking history of 10 or more pack years * lung function parameters: fev1/fvc \< 70%, post-bronchodilator and post-bronchodilator fev1 \< 80% of predicted normal value exclusion criteria: * history and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis * use of inhaled glucocorticosteroids within 4 weeks prior to visit 2 * any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than copd.

Keywords: chronic obstructive pulmonary disease copd
cardiovascular effects of aerosols in residences study

Conditions: Endothelial Dysfunction; Systemic Inflammation

Summary: this study is focused on the effects of hepa filtration to reduce exposures to combustion-derived air pollution (cdap). specifically, the study will evaluate the health benefits of hepa filters and compare the cardiovascular toxicity of two major sources of cdap, specifically traffic and residential wood combustion. specifically, the purpose of this study is to evaluate the ability of portable high efficiency particle air (hepa) filters to reduce exposures to pm2.5 and air pollution indoors and to improve subclinical indicators of microvascular function and systemic inflammation among healthy adult participants. the investigators hypothesize that hepa filter use will help decrease indoor concentrations of cdap thereby helping to mitigate the associated cardiovascular risks.

to address knowledge gaps about health risks of specific pollution sources and to provide new evidence on the health benefits of air pollution interventions, the objectives of this study are: 1) quantify the relationship between low-level exposures to combustion-derived pm air pollution and subclinical indicators of cardiovascular disease risk; and 2) compare the relative impact of hepa filtration for two major pm sources (traffic and residential wood combustion) on these indicators. the use of hepa filters may help to mitigate cardiovascular risks factors caused by combustion-derived air pollution (cdap), (specifically woodstove and traffic emissions). we hypothesize that hepa filter use and improved woodstove technology will help decrease indoor occurrences of cdap. this project will help address knowledge gaps in cdap-related health risks and benefits of interventions. specific objectives include establishing a relationship between exposure to cdap and biomarkers of cardiovascular risk and evaluating the impact of hepa filter use towards improved indoor air quality and health indicators.

Eligibility criteria:
inclusion criteria: * 19 years or older * non-smoking household * lives within study boundaries and in areas of interest exclusion criteria: * copd * asthma * diabetes * heart disease * hypertension * arthritis * gum disease * occupationally exposed to traffic exposures \&/or woodsmoke * if female, pregnant

Keywords: inflammation pathologic processes
bone disease in severely burned children

Conditions: Burn

Summary: bone metabolism is adversely affected by severe burns in children for a period of time.

more closely monitored biochemical and radiologic parameters of bone and mineral metabolism will increase the likelihood of earlier detection of abnormalities and possible therapeutic interventions.

Eligibility criteria:
inclusion criteria: * children age 5-18 years old with at least 40% or more of their body burned. exclusion criteria: * anyone with a burn covering less than 40% of the body or whose burn covers the front of both hipbones. * anyone younger than 5 years old, anyone with a history of cancer or other metabolic disease process, or anyone who is pregnant or has an allergy to tetracycline will also be excluded. * anyone who has participated in an investigational drug trial within the past 60 days from date of admission will be excluded from this study.

Keywords: bone, dexa, parathyroid, diuretic, tetracycline
low-dose cbct protocol for pre-surgical evaluation of the mandibular third molar, a feasible choice?

Conditions: Teeth; Lesion; Tooth Diseases

Summary: low-dose cbct protocol for pre-surgical evaluation of the mandibular third molar. cbct investigations with standard and low dose protocol for evalutation of the mandibular third molar.

two cbct scans were acquired of each examination site: one scan using the standard clinical protocol (90kv, 5ma, 9.4s) and one, the low-dose protocol (90kv, 2ma, 9.4s). all exposures were made with a veraviewepocs 3d f40 (j morita corp.; kyoto, japan) using a field of view (fov) of 4.0 x 4.0 cm and a rotation mode of 180°, voxel size of 0.125 mm.

Eligibility criteria:
inclusion criteria: * a need for a cbct investigation of the mandibula third molar exclusion criteria: * been involved in radiographic examinations for science beforer.

Keywords: cbct
open multi-center safety & efficacy study of low frequency magnetic fields to treat unresponsive diabetic foot ulcers.

Conditions: Neuropathic Diabetic Ulcer - Foot

Summary: an open multicenter trial to document the efficacy and safety of two therapeutic extremely low frequency magnetic fields stimulation devices to promote wound healing of diabetic foot ulcers.

an open multi center trial to document the systemic effects and safety of extremely low frequency electromagnetic fields (elf-mf) stimulation on healing of diabetic foot ulcers (dfu). the study will be performed in two sites: monterrey, nuevo leon, with patients from medical services of the autonomous university of nuevo león, and cuernavaca, morelos with patients from regional general hospital of cuernavaca n. 1 imss, and health services of morelos. two elf-mf investigational exposure systems will be used to stimulate blood at different anatomical regions to enhance wound healing upon peripheral blood mononuclear cell migration to the ulcer site. a) in monterrey, nuevo leon, where dfu subjects should be exposed at either forearm with a sinusoidal oscillating magnetic field of 120 hz with nominal elf-mf amplitude of approximately 0.6mt-0.8mt (6-8 gauss) rms 2 hours/day, 2 times/week. and b) in cuernavaca, morelos, where dfu subjects would be exposed at the thorax with a stimulation system in a quasi-helmholtz configuration, for 25 minutes/day, 2 times/week to a sinusoidal oscillating magnetic field of 120 hz, with nominal elf-mf amplitude of approximately 0.6mt-0.8mt (6-8 gauss) rms. treatment period for both groups will be 14.2 weeks or upon a complete healing. in each treatment session, evolution of ulcer healing should be recorded photographically. efficacy and adverse effects will be searched for during treatment, short-term (\<1 year), and long-term follow-up in both groups (up to 7 years).

Eligibility criteria:
inclusion criteria: * age older than 20 years old * presence of diabetic foot ulcers resistant to medical and/or surgical treatment * medical care prior to admission. exclusion criteria: * pregnant women * cancer diagnosis * bmi \> 3 * non-diabetic leg ulcers * infected wounds * skin autoimmune disease * vasculitis

Keywords: diabetic foot ulcer healing magnetic therapy safety and efficacy wound care
dose-response of exercise on long-term weight loss

Conditions: Obesity; Weight Loss

Summary: the purpose is to examine varying durations and intensities of exercise on long-term weight loss.


Eligibility criteria:
inclusion criteria: 1. female 2. 21-45 years of age 3. bmi = 27-40 kg/m2 4. ability to provide informed consent. 5. ability to provide consent from their personal physician to participate in this study. exclusion criteria: 1. reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (this study is designed to recruit relatively sedentary adults.) 2. diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. 3. currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 24 months. (pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.) 4. non-medicated resting systolic blood pressure \>160 mmhg or non-medicated resting diastolic blood pressure \>100 mmhg, or taking medication that would affect blood pressure. 5. taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade). 6. arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated. 7. history of myocardial infarction or valvular disease. 8. history of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
bavituximab plus carbo and pemetrexed in chemo-naive stage iv non-squamous non-small cell lung cancer (nsclc) subjects

Conditions: Non Small Cell Lung Cancer (NSCLC)

Summary: this is a non-randomized, open-label phase 1b trial to establish the safety and recommended phase 2 dose (rp2d) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage iv non-squamous non-small cell lung cancer (nsclc).

subjects with measurable disease will be assessed for response after every 2 cycles of therapy using recist 1.1 criteria. in addition, progression free survival (pfs), overall survival (os) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated.

Eligibility criteria:
inclusion criteria: * greater than or equal to 18 * histologically or cytologically confirmed stage iv non-squamous nsclc not previously treated with systemic chemotherapy * evaluable disease by clinical or radiographic parameters * no history or concomitant malignancy * adequate organ and marrow function * female subjects with negative urine or serum pregnancy * ecog must be 0 or 1 exclusion criteria: * squamous cell, small cell, or mixed histology * known history of bleeding diathesis or coagulopathy * cavitary tumors or tumors invading or abutting large blood vessels * any history of thromboembolic events * ongoing therapy with oral or parenteral anticoagulants * major surgery within 4 weeks of day 1 of treatment * uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease) * any history of significant vascular disease * congestive heart failure * history of any condition requiring anti-platelet therapy * serious non healing wound * known chronic infection with human immunodeficiency virus (hiv) or viral hepatitis * unable or unwilling to discontinue use of prohibited medications * d-dimers \>2 x uln as measured on 2 separate occasions at least 1 day apart

Keywords: chemotherapy naive stage iv non squamous non small cell lung cancer phase 1b bavituximab chimeric 3g4 u of north carolina at chapel hill
biomarker in tumor tissue samples from patients with rhabdomyosarcoma

Conditions: Sarcoma

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies biomarkers in tumor tissue samples from patients with rhabdomyosarcoma.

objectives: * to determine and quantify the degree of surface insulin-like growth factor i receptor (igf-ir) expression in rhabdomyosarcoma (rms) tumor tissue. * to assess the feasibility and validity of a mass spectrometry assay for igf-ir expression on paraffin-embedded tumor tissue. outline: paraffin-embedded tumor tissue slides are analyzed for insulin-like growth factor i receptor (igf-1r) expression by mass spectrometry and correlated with the results obtained by ihc assay.

Eligibility criteria:
disease characteristics: * diagnosis of rhabdomyosarcoma * alveolar or embryonal rhabdomyosarcoma * available samples from the cooperative human tissue network (chtn) bank patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: alveolar childhood rhabdomyosarcoma embryonal childhood rhabdomyosarcoma previously treated childhood rhabdomyosarcoma previously untreated childhood rhabdomyosarcoma recurrent childhood rhabdomyosarcoma
phase 3 safety and immunogenicity study of aqiv in elderly adults

Conditions: Influenza, Human

Summary: this phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aqiv versus the us-licensed 2017-2018 adjuvanted trivalent influenza vaccine (ativ-1, fluad), and versus an adjuvanted trivalent influenza vaccine (ativ-2), containing the alternate b strain.


Eligibility criteria:
inclusion criteria: * males and females ≥ 65 years old who are healthy or have co-morbidities * individuals who or whose legal representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry * ability to attend all scheduled visits and to comply with study procedures including diary card completion and follow-up exclusion criteria: * history of behavioral or cognitive impairment or psychiatric condition * hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study * abnormal function of the immune system * receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine prior to the day 22 blood collection * any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study additional eligibility criteria may be discussed by contacting the site.
ovulation induction with clomiphene citrate and dexamethasone

Conditions: Infertility

Summary: the purpose of this study is to determine if the addition of dexamethasone to clomiphene citrate will increase the pregnancy rate of intrauterine insemination (iui) cycles.

for decades clomiphene citrate (cc) has been the first line therapy for ovulation induction in anovulatory or oligoovulatory women, and for superovulation in women with unexplained infertility or partners with mild sperm abnormalities. while approximately 80% of patients achieve ovulation with cc, less than half conceive. pregnancy is achieved in approximately 10% of ovulatory cycles. addition of dexamethasone to cc has been shown to result in pregnancy rates of 21-40% in cc-resistant women (defined as patients failing to ovulate on cc alone). a subsequent randomized controlled trial demonstrated higher pregnancy rates in patients with unexplained infertility undergoing intrauterine insemination (iui) with cc + dexamethasone compared to those taking cc alone. in light of the relatively high pregnancy rates achieved in previous trials, we hypothesize that dexamethasone as an adjunct to cc will increase the ovulation rate and pregnancy rate for all appropriate candidates for iu with a standard cc regimen. our study is designed to randomize patients undergoing ovulation induction with iui into two groups: one consisting of a standard cc regimen, and the other consisting of the same cc regimen with the addition of daily dexamethasone. the primary outcome measure is pregnancy.

Eligibility criteria:
inclusion criteria: * active duty military members or dependents seeking infertility treatment at brooke army medical center * primary or secondary infertility * candidate for intrauterine insemination (iui) exclusion criteria: * severe male factor infertility (total motile sperm count \<10 million/ml) * bilateral fallopian tube obstruction * diminished ovarian reserve (baseline follicle stimulating hormone \> 20) * history of clomiphene resistance as determined by a clomid challenge test or prior non-ovulatory cycles while taking clomiphene * known or suspected hypopituitarism or hypothalamic amenorrhea * six or more prior therapeutic cc cycles without a pregnancy * diabetes * renal impairment, hepatitis, hepatic cirrhosis, or myasthenia gravis * osteoporosis * cataracts or glaucoma * congenital adrenal hyperplasia, cushing's disease, or any condition requiring chronic corticosteroid use

Keywords: ovulation induction dexamethasone
bioavailability study of sirolimus tablets 2 mg under fed condition

Conditions: Healthy

Summary: this study is to assess the sirolimus tablets 2 mg of dr. reddy's laboratories limited, india and rapamune® (sirolimus) tablets 2 mg of wyeth laboratories, philadelphia in healthy, adult,human subjects under fed conditions.

open label, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of sirolimus tablets 2 mg under fed conditions.

Eligibility criteria:
inclusion criteria: i. provide written informed consent ii. must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg iii. having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in kg/height in m2 iv. must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance) v. female subjects * of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (iud), or abstinence * surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) exclusion criteria: i. incapable of understanding the informed consent ii. systolic blood pressure less than 90 mm of hg or more than 140 mm of hg iii. diastolic blood pressure less than 60 mm of hg or more than 90 mm of hg iv. oral temperature is below 95.0°f or above 98.6°f v. pulse rate below 50/min or above 100/min vi. history of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs vii. any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function viii. consumption of grapefruit for the past ten days prior to the check-in, in each period ix. regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period x. habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period xi. difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period xii. intake of over the counter (otc) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing xiii. clinically significant abnormalities and / or with significant diseases xiv. confirmed positive in alcohol screening xv. confirmed positive in selected drug of abuse xvi. participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study xvii. confirmed positive in urine pregnancy test xviii. female detected to be pregnant, breast feeding or who is likely to become pregnant during the study
detection of aluminium-reactive t-lymphocytes in patients with vaccination granulomas

Conditions: Granuloma; Aluminum Allergy

Summary: vaccines and subcutanoeus immunotherapy vaccines often contains aluminium, and may induce itching granulomas at the injection site. this is usually diagnosed by patch testing. another way of detecting metal allergy is by investigation metal-specific cells in the blood. we include participants both with and without granulomas, all have a blood test taken where we investigate if any participants have aluminium-specific cirkulation cells, and whether we can detect a difference between participants with and without granulomas.

aluminium-adsorbed vaccines and subcutaneous immunotherapy may induce vaccination granulomas at injection site. most children have concormitant aluminium contact allergy diagnosed by path testing, but in adults the allergy can rarely be detected by patch tests. an alternative to patch testing is the blood in vitro lymphocyte proliferation test (lpt), which we investigated using a well-established lpt protocol. this has previously been shown to detect and characterize metal-specific cells and was used to detect circulating aluminium-specific proliferation. the lpt test is based on a single blood sample and has mostly been used to detect drug hypersensitivity. still, its role in detecting metal allergy is expanding, with recent studies suggesting using the test as a supplement to the patch test when only a few allergens are to be investigated.

Eligibility criteria:
inclusion criteria: * indivicuals with vaccination granulomas * controls without granulomas and no suspected contact allergies exclusion criteria: * pregnancy, breastfeeding, recent vaccination, skin diseases

Keywords: aluminum allergy contact dermatitis vaccination granuloma lpt scit