Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of pioglitazone as an anti-inflammatory for the treatment of cystic fibrosis (cf) lung disease

Conditions: Cystic Fibrosis

Summary: study hypothesis: pioglitazone may decrease inflammation in cystic fibrosis lung disease. primary outcomes: markers of inflammation (neutrophils, elastase, cytokines and bacteria)will be measured in induced sputum specimens before and after a 4 week treatment period with pioglitazone in clinically stable cf patients.

* single-center, open label study of pioglitazone in clinically stable patients with mild to moderate cf lung disease * induced sputum will be obtained from each subject at enrollment (baseline) and again following 28 days of pioglitazone treatment (end of treatment) * changes in markers of inflammation in the sputum samples will be assessed * safety measures, including complete blood count (cbc), serum chemistry, erythrocyte sedimentation rate (esr), c-reactive protein (crp), urinalysis and spirometry, will also be assessed

Eligibility criteria:
inclusion criteria: * male or female \>= 28 years of age * confirmed diagnosis of cystic fibrosis * forced expiratory volume in 1 second (fev1) \>= 40% predicted * clinically stable * ability to reproduce spirometry * ability to understand and sign the informed consent exclusion criteria: * use of an investigational agent within 4-week period prior to visit 1 * chronic daily use of ibuprofen or other nsaids * chronic daily use of insulin,oral diabetic agents or oral hypoglycemic agents * history of hypersensitivity to beta agonists * history of hypersensitivity to glitazones * oxygen saturation\<92% * pregnant, breastfeeding or unwilling to practice acceptable birth control * history of hemoptysis \>30cc per episode within 30 days prior to visit 1 * significant history of hepatic, cardiovascular, renal,neurologic, hematologic or peptic ulcer disease * serum glutamic-oxaloacetic transaminase (sgot)/(serum glutamic pyruvic transaminase (sgpt) \>3 times the upper limit of normal at screening, documented biliary cirrhosis,or portal hypertension * creatinine \> 1.8 mg/dl at screening * inability to swallow pills * presence or abnormality that in the opinion of the investigator would compromise the safety or the quality of the data * subjects who have routinely taken ibuprofen or other nsaids; prednisone or other systemic corticosteroids, or insulin, or oral diabetic agents within 4 weeks prior to visit 1 or who have taken these medications as needed within 72 hours prior to visit one will be excluded

Keywords: prescription drugs administration, oral durable medical equipment kinetics
optimal strategy for the management of ascus cytology in health care services of medellin, colombia

Conditions: Cervical Abnormalities; Cervical Intraepithelial Neoplasia Grade 2/3; Cervical Cancer

Summary: cervical cancer as well cervical preneoplastic abnormalities (cin2+) are cause by human papillomavirus (hpv) infection. these abnormalities have been historically detected by cervical cytology, but recent evidence shows that hpv testing is superior to cytology to detect cervical lesions that eventually will progress to cancer. despite evidence, conventional cytology (pap) remains as a primary screening test in colombia and hpv test is recommended as a triage test for women with atypical squamous cells of undetermined significance (asc-us) in settings around the world. women with asc-us have low risk to cin2+ but higher than healthy population, and therefore it is important to provide appropriate clinical management. however, there is no consensus of how to deal women with asc-us and therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2) repeat conventional cytology at 6 and 12 months and 3) hpv testing. the main objective of this study is to compare the effectiveness and the efficient among the strategies as well as to evaluate the acceptability of the hpv testing in a real-life setting.

the aim of this study is to compare the effectiveness and efficiency of immediate colposcopy (ic), repeat conventional cytology at 6 and 12 months (rc) and hpv triage (hpv) (qiagen-the digene hpv test®) for the clinical management of women with asc-us insured in healthcare management organizations (hmo) within the colombian health security system. this study randomized 2,661 20-69 years old women with asc-us, insured in hmos in medellin-colombia to 3 arms: ic, rc and hpv. all women are scheduled for a visit at 2 years after recruitment that includes hpv-test/cytology and colposcopy either if hpv+ (rlu\>=1) or abnormal cytology (\>=asc-us). this colposcopy is performed by a trained colposcopist and women are followed-up according to a well-defined algorithm. the fewer high-grade cervical neoplasia (cin2+) rate at the end of following will determine the most effective arm. the most efficiency arm will be which reach the major effective with the minimum resource (cytologies, colposcopies and histologies) consumed. the resource consumed is being retrieved from the hmos. this study also pretends to evaluate the acceptability of the hpv testing. this study will allow us to know if within the colombian health security system, the hpv test will remain superior to repeating cytology and/or to immediate colposcopy as it has been demonstrated in randomized controlled trials carried out in outside settings.

Eligibility criteria:
inclusion criteria: * asc-us cytology, living in metropolitan area of medellin exclusion criteria: * previous abnormal cytology

Keywords: human papillomavirus cervical cancer health services research colombia cervical intraepithelial neoplasia
studying the effects of cannabis on vasculature

Conditions: Cardiovascular Diseases; Inflammation; Atherosclerosis

Summary: cannabis is commonly used globally. it is associated with psychiatric problems, but the effects on the cardiovascular system are unclear. in this project, the investigators plan to study the effects of cannabis on the cardiovascular system. this will be done by using a non-invasive test to measure blood vessel function and by using blood samples to measure inflammation. as a control for this project, the investigators would like to test the blood vessel function and inflammation levels of participants who do not use cannabis. this study will provide important information on the long term cardiovascular effects of cannabis.

cannabis is the most commonly used illicit drug in the world, but the investigators do not know the long-term effects on the cardiovascular system in humans. the investigators have data from cell culture and small animal studies that cannabis is toxic to the cardiovascular system. recently legalized in canada, the long-term effects of cannabis use on the cardiovascular system may not be apparent for several decades. the purpose of this study is to test the effect of cannabis use on the vascular system. using a non-invasive test of vascular function, the investigators would like to assess the effects of cannabis on chronic cannabis users. the investigators would also like to test if cannabis use by smoking and/or vaping causes adverse cardiovascular effects acutely. lastly, the investigators would like to test blood from chronic cannabis users for inflammatory cytokines, which could further support our hypothesis that cannabis damages the cardiovascular system via inflammation.

Eligibility criteria:
inclusion criteria: * age: 19 to 80 * males and females * all ethnicities * cannabis use at least 3-4 times per week or more in the past 6 months (50 volunteers, experimental group) * patients who do not use cannabis (50 volunteers, control group) * no history of cardiovascular disease exclusion criteria: * that ingest cannabis containing cannabidiol (cbd) * that are unable to provide a receipt for the cannabis product(s) they ingest * that are unwilling to stop consuming soy products and/or genistein 48 hours prior to appointments.
the diagnostic utility of ultrasound in pelvic inflammatory disease (pid)

Conditions: Pelvic Inflammatory Disease

Summary: pelvic inflammatory disease (pid) represents a significant and complex health issue affecting women, particularly those of reproductive age. characterized by the infection and inflammation of the reproductive organs, pid often results from ascending infections primarily caused by sexually transmitted pathogens, such as neisseria gonorrhoeae and chlamydia trachomation. however, it can also be associated with endogenous bacteria or occur following surgical procedures.

the diverse manifestations of pid from asymptomatic cases to acute presentations, pose significant challenges in diagnosis and prompt treatment. accurate diagnosis is crucial, as untreated infections can lead to severe complications, including infertility, chronic pelvic pain, and ectopic pregnancies.

Eligibility criteria:
inclusion criteria: * women of reproductive age (18-45 years) presenting with symptoms suggestive of pelvic inflammatory disease (pid). * patients who have been clinically diagnosed with pid based on symptoms such as lower abdominal pain, fever, abnormal vaginal discharge, and tenderness upon pelvic examination. * patients who have undergone preliminary diagnostic tests, such as high vaginal swab (hvs) and urine microscopy, culture, and sensitivity (m/c/s), prior to ultrasound assessment. exclusion criteria: * pregnant women, due to potential confounding factors in ultrasound findings and differential diagnosis. * patients with chronic pelvic pain not related to acute pid episodes. * patients who do not provide informed consent for participation in the study. * patients with a history of recent pelvic surgery within the last 6 months, as postoperative changes may affect ultrasound findings.
thc and ketamine effects in humans: relation to neural oscillations and psychosis

Conditions: Cannabis; Ketamine

Summary: the aim of the research protocol is to evaluate cannabinoid-glutamate interactions in humans. as part of this aim the investigators will assess the safety and tolerability of the combination of nmda antagonist, ketamine, and the cannabinoid, delta-9-tetrahydrocannabinol (thc), in healthy adult subjects, and characterize the interactive effects of ketamine and thc on various electrophysiological (eeg), cognitive, and behavioral outcomes.

the investigators will examine the contributions of the cannabinoid receptor (cb1r) and n-methyl d-aspartate receptor (nmdar) systems to psychosis in healthy humans beings using thc and ketamine respectively (both alone and in combination). healthy subjects (n=21) will receive thc (active or placebo) followed by ketamine (active or placebo) in a double blind, randomized, crossover (2x2) design. psychotomimetic effects will be assessed before and at various time points after the drug infusions. eeg indices of information processing, specifically neural oscillations, will be assessed during peak drug effects.

Eligibility criteria:
inclusion criteria: 1. 18 to approximately 45 years old 2. good physical and mental health as determined by history, the structured clinical interview for dsm-5 tr (scid-np) and collateral information, physical and laboratory examinations, ecg and vital signs. 3. weight of 100 kg (220.46 lbs.) or less (inclusive). exclusion criteria: 1. unstable serious medical conditions. at the discretion of the investigator, subjects with unstable medical conditions that may necessitate changes in medical treatment and hence influence study outcomes will be excluded. 2. uncontrolled hypertension, long qt syndrome, and seriously abnormal ekg results. ekg abnormalities will be reviewed by the pi and eligibility decisions will be made at the discretion of the pi. 3. a hearing deficit in greater than one band in an ear detected using a welch-allyn audioscope (500, 1000, 2000 and 4000 hz threshold will be evaluated) 4. positive pregnancy test
an open-label, single-arm extension study to evaluate the long-term safety of denosumab administration in postmenopausal women with low bone mineral density

Conditions: Low Bone Mineral Density

Summary: an open-label, single-arm extension study to evaluate the long-term safety of denosumab administration in postmenopausal women with low bone mineral density


Eligibility criteria:
inclusion criteria: * subject must be ambulatory * subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit * signed informed consent must be obtained before any study-specific procedures exclusion criteria: * experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study. * developed grade 3 or 4 laboratory abnormalities based on common terminology criteria for adverse events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment. * newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease. * using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, serms, systemic glucocortiocosteriods.

Keywords: bone loss osteoporosis
evaluation of multi-cancer early detection testing in a high-risk military population: the sentinel study

Conditions: Cancer Diagnosis

Summary: the purpose of this research study is to evaluate the possible benefits of an investigational, but commercially available galleri multi-cancer early detection (mced) blood test which is designed to detect many types of cancer early in veterans who have served in the military in active duty. the name of the screening blood test being studied is: -grail galleri mced test

this research study aims to assess the performance of the galleri multi-cancer early detection (mced) screening test in a military population and to compare the number and types of cancers diagnosed using mced testing versus standard of care. this research study will give doctors and participants results of galleri® blood tests which is designed to detect many types of cancer. the research study procedures including screening for eligibility, blood draws, questionnaires, and clinic visits. participation in this research study is expected to last for up to 1 year. it is expected that about 1,500 people will take part in this research study. the department of defense (dod) is funding this study.

Eligibility criteria:
inclusion criteria: * active-duty or national guard/reserves military service for eight or more years * age ≥ 45 * received care at a va facility within past 5 years * able to sign informed consent * willingness to travel to dana-farber cancer institute in boston, ma, for diagnostic testing if screening test indicates possible malignancy exclusion criteria: * individuals diagnosed with invasive malignancy within 3 years of enrollment (non- melanoma skin cancer is acceptable) * individuals with evidence of symptomatic or active cancer requiring therapeutic intervention at the time of participation (hormone therapy for breast/prostate cancer is acceptable) * individuals in the process of being evaluated for a clinical suspicion of cancer

Keywords: cancer diagnosis
nutritional support with tgf-β2 food for special medical purposes (tgf-β2 fsmp) in adult allogeneic hematopoietic stem cell transplantation (allo-hsct) for the prevention of malnutrition: a prospective, randomized, multicenter study

Conditions: Malnutrition (Calorie); Stem Cell Transplant Complications

Summary: prospective, randomized, multicenter study to confirm the potential benefits of tgf-β2 enriched fsmp. the primary objective is to evaluate the superiority of supplementing with tgf-β2 fsmp (experimental arm) compared to best supportive treatment (bst) in preventing malnutrition in patients submitted to allo-sct. the secondary endpoints include the assessment of reduction of incidence of severe acute gvhd at day +100.


Eligibility criteria:
inclusion criteria: * intact intestinal tract * life expectancy more than 12 weeks * allogeneic stem cell transplantation * signed informed consent exclusion criteria: * active hematological disease at the beginning of conditioning * personal history of inflammatory bowel diseases * personal history of bowel resection * personal history of gastric bypass procedures * enrolment in a competitive prospective study (malnutrition or gvhd as primary outcome) * subjects with known hypersensitivity to milk proteins or components of modulen-ibd

Keywords: stem cell transplant malnutrution gvhd
adding a combined program of therapeutic exercise and self-massage to the conventional approach of compression stockings and preventive measures in chronic venous insufficiency.

Conditions: Chronic Venous Insufficiency, CVI

Summary: the purpose of this study is to evaluate whether the inclusion of a physiotherapy approach in primary care consultation prescribing exercises and teaching self-massage techniques would be well accepted by patients of chronic venous insufficiency and provide higher benefits in the self-management.

this study aimed at comparing the effects of conventional therapy approaches based on compression stocking and prevention measures with a combined program of these techniques added to therapeutic exercise and self-massage explained by a physiotherapist on on functionality, general physical activity and oedema of people with cvi. in this sense, a randomized controlled trial two armed group was designed.

Eligibility criteria:
inclusion criteria: 1. diagnosed of cvi 2. aged between 18 and 85 years and 3. with mobile or email address to send the study information and follow-up exclusion criteria: 1. mental or psychological condition that impairs the study development 2. comorbidities that impair the physical activity performance 3. surgical interventions during the 6 previous months before the intervention or during the study development 4. deep vein thrombosis 5. active leg ulcer 6. pregnancy.

Keywords: therapeutic exercise massage compression stocking physiotherapy
intracranial pressure and brain function: effects of head down tilt upon brain perfusion and cognitive performance

Conditions: Intracranial Hypertension

Summary: the aim of the study is to understand the relationship between intracranial pressure regulation, cerebral tissue oxygenation and cognitive functioning. more specifically, the study tests the hypothesis that head down tilt will increase intracranial pressure (not measured in this study, but demonstrated in previous studies), will induce venous congestion and facial swelling, decrease intracranial tissue oxygenation and hamper brain functioning. the objectives of the study therefore are to assess young healthy people during head-down tilt (hdt), and to assess cognitive brain functioning, cerebral tissue oxygenation (non-invasively), frontal skin thickness, cerebral perfusion and neuronal functioning via event-related potentials.


Eligibility criteria:
inclusion criteria: * physically and mentally healthy male test subjects that are able and declare in writing their willingness to participate in the entire study and successfully passed the psychological and medical screening * aged between 18-55 years old with a body mass index (bmi) of 20-28 kg/m2, weight between 65-100 kg, and a height between 158-195 cm * demonstrable medical insurance and official certificate of absence of criminal record exclusion criteria: * inability to sleep on the back * drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day) * smoking within the past 6 months prior to study commencement * migraine or other chronic head aches * previous psychiatric illness * subjects suffering from weak concentration * history of psychological or central nervous disorders * hiatus hernia * gastro-oesophageal reflux * diabetes mellitus * pronounced orthostatic intolerance (\< 10 min standing) * kidney disorder: deviations from normal values for creatinine in plasma. (normal value: creatinine \< 1.20 mg/dl) * thyroid gland disorder: deviations from normal values for thyroid stimulating hormone (tsh) in plasma. (normal range: tsh 0.55-4.80 munits/l) * anaemia: hb under normal values (normal values of hb for men: 13.5-17.5 g/l) * elevated risk of thrombosis * high likelihood of coagulopathy assessed by a clinical standard questionnaire * chronic back complaints * history of lumbar surgery * history of lumbar spine trauma * motor or sensory deficits as assessed by neurological examination * contraindications against mri * imprisoned at the time of the study * taking medications that may impair cognitive function, autonomic function or any of the study procedures * ophthalmological conditions including glaucoma, retinopathy, severe cataracts, eye trauma or implants * any other medical condition that the investigators consider a contraindication to the study procedures that would make it unsafe or confound the measurements.

Keywords: cognitive functioning brain tissue oxygenation cerebral perfusion head down tilt
assessment of respiratory symptoms after corticosteroid treatment period using impedance pneumography

Conditions: Obstructive Bronchitis

Summary: introduction lung function assessment of preschool children is hindered by their limited co-operation in conventional tests such as peak expiratory flow (pef) or spirometry and the methods available for younger children are, again, laborious and time consuming. however, impedance pneumography (ip) records indices of airway obstruction during normal sleep at home and has been shown accurate in wheezy preschool children (seppä et al. j appl physiol 2013). aim of the study the general purpose of this study is to assess the clinical value of the information provided by overnight home recording of tidal breathing by means of ip technique in young children with asthmatic symptoms and inhaled corticosteroid (ics) medication. the main hypothesis is that ip measurement can distinguish between groups whose asthmatic symptoms recur or do not recur after ending the ics drug treatment period. methods the study recruits 1-5 year old children (n=75) who have presented at the emergency room due to obstructive bronchitis and for whom an ics drug treatment period has been prescribed based on the national guidelines. the subjects will perform three overnight ip measurements at home at two weeks intervals close to and after ending of the treatment period. significance of the study being an affordable, simple and convenient ambulatory measurement method, ip may bring needed objectivity to asthma diagnostics and asthma drug response assessment in young children.

quality control and quality assurance information of study personnel and training all personnel involved with the use of the ip measurement device will be instructed by ville-pekka seppä. protocol amendments essential amendments in the research protocol will be reviewed by the institutional review board and informed to national supervisory authority of welfare and health (valvira). data handling and record keeping electronic data collection electronic data will consist of ip recorder device data files (.ipr). upon complete protocol execution there will be three files for each patient. these files will be stored in a computer in tays allergiakeskus. data management access to all collected patient information and the patient information collected before the study in the primary care centers will be accessible to rn tiina mäki (0503439195), md marita paassilta, and md jussi karjalainen of allergiakeskus. research group members from tut will have access only to data that does not enable identifying individual patients and where individual patients are referred to by participant codes. study subject register the study subject register will be treated per the finnish personal data act article 10.

Eligibility criteria:
inclusion criteria: * age 1-5 yrs * recurrent obstructive bronchitis * inhaled corticosteroid treatment has been prescribed exclusion criteria: * laryngeal disease * tracheobronchial malacia * parenchymal lung disease * history of bronchopulmonary dysplasia * active implantable medical such as pacemakers

Keywords: device investigation