Kornimate/medical-research-clean huggingface dataset:
statins and selective cyclooxygenase-2 receptor inhibitors in blunt chest trauma

Conditions: Blunt Chest Trauma; Acute Respiratory Distress Syndrome

Summary: background: lung contusion affects 17%-25% of adult blunt trauma patients, and is the leading cause of death from blunt thoracic injury. statins are lipid-lowering drugs with recently suggested anti-inflammatory and antioxidant properties. cyclo-oxygenase-2 (cox-2) is a key enzyme in the production of prostaglandins (pg), and evidence suggests that cox-2 plays an important role in the pathogenesis of acute lung injury (ali). aims: the current study aims at evaluating the beneficial effects of statins and cox-2 receptor inhibitors on ali elicited by blunt trauma to the chest. methods: after approval by the institutional ethics and a scientific committee, and obtaining informed consent , patients admitted to the emergency department (ed) due to blunt trauma with a diagnosis of lung contusion will be enrolled in the study.the effects of statins and cox 2 inhibitors on ali will be assessed by recording clinical parameters and measuring inflammatory mediators levels in the serum and in the bronchoalveolar space. expected results: the investigators expect to find that the proposed treatment will be effective in reducing ali burden. the investigators also suppose that using a combination of those drugs will synergistically potentiate their effect on ali.


Eligibility criteria:
inclusion criteria: * patients older than 18 years of age * diagnosis of lung contusion by physical examination, chest xrays, history by the patient, accompanying persons or police. * ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation. * admission to ward exclusion criteria: * penetrating trauma * current use of lipid-lowering therapy, use of non steroidal anti-inflammatory drugs. * current use of postmenopausal hormone-replacement therapy * evidence of hepatic dysfunction (an alanine aminotransferase level more than twice the upper limit of the normal range), a creatine kinase level more than three times the upper limit of the normal range. * creatinine level higher than 2.0 mg/dl * known uncontrolled hypertension (systolic blood pressure \>190 mm hg or diastolic blood pressure \>100 mm hg * history of uncontrolled hypothyroidism (thyroid-stimulating hormone level\> 1.5 times the upper limit of the normal range) * psychiatric disorders * pregnancy * known allergy or intolerance to one of the protocol drug

Keywords: lung contusion injury cyclooxygenase statin
open-label berotralstat access to hae patients previously enrolled in berotralstat studies

Conditions: Hereditary Angioedema; HAE

Summary: this is a phase 3b open-label study providing access to berotralstat for hae patients who were previously enrolled in berotralstat studies.

apex-a, 7353-312, is a single-arm, open-label, multicenter study. the study will be conducted in countries where berotralstat is not available either commercially or via another mechanism and is planned in countries where pediatric participants have been enrolled in bcx7353-304 (study 304). adult and adolescent (≥12 years) participants will receive berotralstat 150 mg administered orally once daily (qd). pediatric participants will receive a weight-appropriate dose. the study will assess the long term safety and tolerability of berotralstat. eligible subjects will be enrolled directly into study bcx7353-312 (study 312) from studies 302, 204, and 304. subjects will receive berotralstat administered orally once daily (qd). subjects will return to the clinic every 24 weeks for drug dispensation and safety monitoring. participants form studies 302 and 204 may remain on study for up to 480 weeks (approximately 10 years). participants from study 304 may remain in the study until 16 years of age and have access to berotralstat via another mechanism; or up to 5 years, whichever comes first. safety and tolerability will be evaluated through assessment of serious adverse events (saes) and treatment-related, treatment-emergent adverse events (teaes). up to 139 subjects are planned to enroll.

Eligibility criteria:
key inclusion criteria: * males and females currently enrolled in biocryst-sponsored study 302, 204, or 304 * participant or parent/legally designated representative (for participants \<18 years of age) able to provide written informed consent. * would benefit from continued berotralstat treatment * acceptable effective contraception key exclusion criteria: * pregnancy or breast-feeding * any condition or situation, including medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's safety or ability to participate in the study * use of other medications for long-term prophylaxis of hae attacks at the baseline visit or any time during the study. * use of any other investigational medicinal product at the baseline visit or any time during the study.

Keywords: prophylaxis
high-density (hd) wave mapping in subjects with atrial fibrillation as a predictor of recurrence after a single ablation procedure using a pvi-only strategy

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Cardiac Arrhythmia

Summary: the aim is to use the advisor™ hd grid mapping catheter, sensor enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a pvi only approach and a contact catheter.

this clinical investigation is intended to characterize the left atrial substrate using the advisor™ hd grid mapping catheter, sensor enabled™ in an hd wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (pvi) approach without further substrate modification. this is a post-market, single-arm, multi-center, prospective interventional study of the advisor™ hd grid mapping catheter, sensor enabled™. this study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation. approximately 300 subjects at up to 20 sites worldwide will be enrolled. subjects will be followed until they complete their 12-month visit. clinical investigation visits will occur at baseline (confirmation of eligibility), index procedure, 3 months, 6 months, and 12 months. endpoints will be analyzed when all subjects have completed their 12-month follow up visits.

Eligibility criteria:
inclusion criteria: 1. documented atrial fibrillation with planned endocardial ablation procedure 2. age 18 years or older 3. able and willing to provide written informed consent prior to any clinical investigation related procedure 4. able and willing to complete all required study procedures through 12 months exclusion criteria: 1. long-standing persistent atrial fibrillation defined as continuous af greater than 12 months in duration 2. previous ablation or surgery in the left atria 3. implanted left atrial appendage occluder 4. implanted mitral or tricuspid valve replacement 5. implanted cardiac defibrillator (icd) 6. participation in another clinical investigation that may confound the results of this study 7. pregnant or nursing 8. presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 9. life expectancy less than 12 months
from cytotrophoblast to syncytiotrophoblast

Conditions: Syncytiotrophoblast

Summary: a deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.the aim of this study is to compare telomere length, aggregate formation, and senescence markers in placentas from complicated pregnancy with placentas from normal pregnancy.

protocol summary no. 2 for research 0202-14 of date: 22/11/2014. rationale for the research a deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications. the aim of this study is to compare telomere length, aggregate formation, and senescence markers in the syncytiotrophoblast of placentas from complicated pregnancy with placentas from normal pregnancy. telomere lenght and aggregate formation will be assessed by the fluorescent intensity of telomere fish. senescence will be assessed by immunohistochemistry for the markers - sahf, cyclin dependent kinase inhibitors p16/p21, hlax, ervwe1, sa-b-gal. the study groups 1. a retrospective arm - paraffin blocks which were collected over the years from placentas from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) will be compared to blocks of placentas from normal pregnancies. 2. the prospective arm - placental from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) . will be compared to placentas of normal pregnancies. 3. a laboratory model based on human placenta cell cultures

Eligibility criteria:
inclusion criteria: * placentas from normal and complicated pregnancy exclusion criteria: * women consent

Keywords: cytotrophoblast syncytiotrophoblast placentas intrauterine growth restriction preeclampsia placenta accrete
the effects of exercise on appetite regulation in overweight/obese individuals

Conditions: Obesity

Summary: in this study the investigators are examining the effects of a 12-week exercise program (intervention) on measures of appetite and food intake regulation in overweight to mildly obese healthy adults. the investigators hypothesize that individuals who lose a significant amount of weight in response to the intervention will show a reduction in the brain response to food cues as measured by functional magnetic resonance imaging (fmri) when compared to those who do not lose weight. these changes in neuronal activity will be associated to physiologic and behavioral measures.


Eligibility criteria:
inclusion criteria: * all ethnic groups and both genders; * age: 21-45 yrs; * bmi: 27-35; * weight stable within +/- 5 percent in the last 6 months; * sedentary (less than 1 hour of planned physical activity by self-report). exclusion criteria: * history of cardiovascular disease (cvd), diabetes mellitus, uncontrolled hypertension, untreated thyroid disease, renal disease, hepatic disease, or any other medical condition affecting weight or energy metabolism; * unable to effectively exercise due to cardiac, pulmonary, neurologic or orthopedic reasons; * unable to pass screening graded exercise treadmill test; * currently smoking; * medications affecting weight, energy intake (ei) or energy expenditure (ee) in the last 6 months; * weight loss or weight gain of \>5 percent in past 6 months; * currently pregnant, lactating or less than 6 months post-partum; * bariatric surgery; * major psychiatric disorder, presence of alcohol or substance abuse, current depression by history and/or a score \>21 on the he center for epidemiologic studies depression scale (ces-d), history of eating disorders and/or a score of \>20 on the eats-26; * contraindication to mri
oral water ingestion in heart transplant patients

Conditions: Blood Pressure; Cardiac Transplantation

Summary: in this study the investigators propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. the investigators will test the hypothesis that water ingestion will increase the systemic vascular resistance.

in this study we propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. we will test the hypothesis that water ingestion will increase the systemic vascular resistance. this study will occur in patients status post cardiac transplantation during their clinical right heart catheterizations. invasive hemodynamics including cardiac outputs and plasma norepinephrine levels will be measured before and 30 min after the water ingestion.

Eligibility criteria:
inclusion criteria: * s/p cardiac transplantation scheduled for clinical right heart catheterization * age \> 18 years exclusion criteria: * significant tricuspid regurgitation * inability to safely swallow 500 ml of water * other major medical comorbidities such as advanced renal disease where water ingestion may be harmful to patient

Keywords: water blood pressure vascular resistance cardiac transplantation
a study of the effect of ly2189265 on blood pressure and heart rate in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the effects of 2 doses of ly2189265 on blood pressure and heart rate using 24-hour ambulatory blood pressure monitoring (abpm), in participants with type 2 diabetes mellitus treated with oral antihyperglycemic medications (oams).


Eligibility criteria:
inclusion criteria: * type 2 diabetes taking 1 or more oral diabetes medications and have taken these medications for at least 1 month prior to screening * glycosylated hemoglobin (hba1c) value ≥7% and ≤9.5% at screening * mean blood pressure \>90/60 millimeters of mercury (mmhg) and \<140/90 mmhg at screening * if treated for hypertension, are taking 3 or less antihypertensive medications and have been taking these medications for at least 1 month prior to screening * stable weight for 3 months prior to screening * body mass index (bmi) greater than or equal to 23 kilogram-meter squared (kg/m\^2) * willing to wear an ambulatory blood pressure monitoring device for at least 24 hours on multiple occasions * women of childbearing potential must test negative for pregnancy and be willing to use a reliable method of birth control * male participants must use a reliable method of birth control exclusion criteria: * myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure class iii or iv at screening * ongoing or history of frequent intermittent tachyarrhythmia * resting heart rate \ 100 bpm at screening * work rotating shifts or work during the hours of 2200 to 0700 * chronic insulin therapy * use of a glucagon-like peptide 1 (glp-1) receptor agonist within 3 months prior to screening, or a dipeptidylpeptidase-iv (dpp-iv) inhibitor within 2 weeks prior to screening * nondominant arm circumference \>42 centimeter (cm) * use of drugs to promote weight loss * chronic use of systemic steroids * gastric emptying abnormality or bariatric surgery * hepatitis, other liver disease, or alanine transaminase (alt) \>3 times the upper limit of normal * acute or chronic pancreatitis * severe renal impairment * active autoimmune disease or uncontrolled endocrine abnormality * self or family history of thyroid cancer, medullary c-cell hyperplasia, or type 2a or 2b multiple endocrine neoplasia * calcitonin value greater than or equal to 20 picograms per milliliter (pg/ml) at screening * transplanted organ except corneal transplants * active or untreated cancer or in remission \<5 years, except skin, in situ cervical, or prostate cancer * sickle-cell disease, hemolytic anemia, or another hematological condition that may interfere with hba1c testing

Keywords: type 2 diabetes diabetes ambulatory blood pressure monitoring abpm blood pressure heart rate
f18-flouride pet/ct in acute knee injury

Conditions: Knee Injury

Summary: 18f-fluoride is a positron-emitting bone-seeking agent with favorable pharmacokinetic properties. its uptake mechanism resembles that of 99mtc-mdp. after iv administration, 18f-fluoride diffuses through the bone capillaries into the bone extracellular fluid (ecf). its plasma clearance is more rapid than that of 99mtc-mdp and its single-passage extraction efficiency is higher. the fast blood clearance of 18f-fluoride results in a better target- to- background ratio. bone uptake of 18f-fluoride is two-fold higher than that of 99mtc-mdp. combining the favorable pharmacokinetic characteristics of 18f-fluoride with the high performance of pet technology, 18f-fluoride is a valuable imaging modality of the skeleton. there are only few manuscripts on the role of static 18f-fluoride pet for detection of lesions in patients referred for non-oncologic indications the purpose of the study is to prospectively assess the added value of fluoride pet/ct in the clinical setting of acute knee injury. the findings of fluoride pet/ct will be correlated with those found on arthroscopy and mri which the currently used diagnostic techniques with a high, however, not perfect diagnostic accuracy regarding the issue of bone injury which is a critical component on the long term outcome after knee injury.

we intend to inject only 5mci of fluoride, as we already did before, thus reducing the radiation exposure to half of that of the routine tc-mdp bone scintigraphy. we will refer 50 patients over the age of 18 who had knee trauma, intent to or had mri assessment and are scheduled for arthroscopy. the compartments of the injured knee will be evaluated on each of the modalities. exclusion criterion is pregnancy

Eligibility criteria:
inclusion criteria: * patients over the age of 18 who had knee trauma exclusion criteria: * pregnancy * age under 18 years

Keywords: knee trauma mri arthroscopy patients over the age of 18 who had knee trauma intent to or had mri assessment scheduled for arthroscopy
a study to assess the bioequivalence of aprepitant and fosaprepitant and the effect of food on aprepitant bioavailability (0869-165)

Conditions: Chemotherapy-Induced Nausea and Vomiting

Summary: this study will assess the bioequivalence of single oral doses of aprepitant (mk0869) to a single intravenous infusion of fosaprepitant (mk0517) and also determine the effect of food on the bioavailability of oral aprepitant.


Eligibility criteria:
inclusion criteria: * subject is in good health * subject is a nonsmoker * subject is willing to comply with the study restrictions exclusion criteria: * subject has a history of any illness that might confound the results of the study or might make participation in the study unsafe * subject has a history of stroke, seizures, or major neurological disorder * subject has a history of cancer * subject consumes more than two alcoholic drinks per day * subject consumes more than three caffeinated beverages daily
oral treatment with pl-56 in patients with iga nephropathy - an explorative study

Conditions: IGA Nephropathy

Summary: the study will investigate the effect of pl-56 on albumin leakage and renal function (glomerular filtration rate) in patients with iga nephropathy. it will also assess the safety of treatment with pl-56.


Eligibility criteria:
inclusion criteria: * signed informed consent * female or male patient \> 18 years * biopsy-verified iga nephropathy * proteinuria: u-albumin \>500 mg/24 h * s-creatinine \< 200 umol/l * a minimum of four available sample results (u-albumin and s-creatinine) prior to inclusion in the study. exclusion criteria: * severe gastrointestinal disorders which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the investigator * consumption of an investigational drug within 30 days prior to enrolment * unacceptable blood pressure (treated or untreated), defined as a systolic value \>150 mm hg and/or diastolic \>90 mm hg * hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the investigator * patients in whom an ace inhibitor was introduced/changed during the last three months prior to enrolment * patients treated with immuno-suppressive drugs * patients unable to take oral medication * severe liver disease (defined as asat and/or alat and/or gamma-gt above twice the normal value). * uncontrolled (treated or untreated) congestive heart failure as judged by the investigator * patients with diabetes * patients with current malignancy or history of malignancy during the last three years * history or presence of psychological or psychiatric illness which may interfere with the patient´s ability to adhere to the protocol * alcohol or drug abuse (present) * patients unwilling to meet the requirements of the protocol * other medical or social reasons for exclusion at the discretion of the investigator * use of drugs inhibiting the cytochrome p-450 enzyme cyp3a4 (including grape fruit juice) * kidney transplanted patients * for women only: pregnant or breast feeding; unwilling to use adequate contraception during the study (only women of childbearing potential)
effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense

Conditions: Healthy

Summary: the aim of this study was to investigate the effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense of healthy individuals.

a randomized controlled crossover trial will be conducted at a biomechanics laboratory with healthy males. all participants will perform with a washout period of 1 week: a control condition (5-minute rest) and 4 local muscle fatigue protocols (concentric of quadriceps; concentric of hamstrings; eccentric of quadriceps; eccentric of hamstrings) in an isokinetic dynamometer at 30º/s. three maximum voluntary isometric contractions (mvic) of quadriceps and hamstrings will also be assessed in the beginning of all conditions. knee joint position sense will be assessed before and immediately after the fatigue protocols/control condition, through active concentric and eccentric positionings/repositionings, in sitting and prone positions, to a target range of 45º of knee flexion in an isokinetic dynamometer. surface electromyography electrodes will also be placed on the vastus lateralis and biceps femoris during all procedures.

Eligibility criteria:
inclusion criteria: * males aged between 18 and 30 years; * without current or previous knee pathology or surgery; * with a low or moderate physical activity level, according to the international physical activity questionnaire; * normal body mass index (under 24.9 kg/m2), according to the world health organization. exclusion criteria: * those with cardiorespiratory, neurological or vestibular pathologies; * with positive knee integrity tests (anterior drawer, lachman's test, posterior drawer; valgus and varus stress testes); and * those taking any medication that can affect motor control (sedatives, anxiolytics, antibiotics, analgesics, nsaids or myorelaxants).

Keywords: muscle fatigue knee joint position sense proprioception