Kornimate/medical-research-clean huggingface dataset:
destination therapy post approval study

Conditions: Chronic Heart Failure

Summary: medtronic is sponsoring the heartware™ hvad™ destination therapy (dt) post approval study (pas) to further confirm safety and effectiveness of the heartware ventricular assist device system (hvad system) when used as intended, in "real-world" clinical practice. the destination therapy post approval study (dt pas) is conducted within medtronic's product surveillance platform.

the heartware destination therapy (dt) post approval study (pas) is a prospective, observational, multi-site study. enrollment into the dt pas will be comprised of newly enrolled, commercial use dt patients with the heartware ventricular assist device system (hvad system). patients enrolled in dt pas will be followed for 5 years post-implant or until study closure, patient death, patient exit from the pas (i.e., withdrawal of consent), or patient has hvad device removed without replacement (i.e., transplant, recovery) or device is exchanged for non-hvad. the total estimated study duration is approximately 7 years.

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient is intended to receive or be treated with a heartware hvad system for use as destination therapy * patient is consented prior to the hvad implant procedure exclusion criteria: * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and or effectiveness) * patient less than 18 years of age. * patient with previous support by long-term mechanical circulatory support (mcs), not including temporary mechanical circulatory support.

Keywords: heart failure heart diseases cardiovascular diseases
tradipitant for functional dyspepsia

Conditions: Functional Dyspepsia

Summary: to evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, and postprandial symptoms in patients with functional dyspepsia.


Eligibility criteria:
inclusion criteria: * able to provide written consent * body mass index (bmi) of 18-35 kg/m2 * absence of other diseases which could interfere with interpretation of study results exclusion criteria: * current h. pylori infection * pregnancy or nursing * recent history of alcohol use disorder or substance use disorder

Keywords: tradipitant nk-1 antagonist neurokinin 1 receptor
the microbiology of pleural infection

Conditions: Pleural Infection; Pleural Infection Bacterial

Summary: pleural infection (pi) is a common, severe and complicated disease with considerable morbidity and mortality. (1,2) the knowledge of pleural infection microbiology remains incomplete. sequencing of the bacterial 16s rrna gene is a reliable methodology to discover the total microbiome of complex samples. the investigators designed a translational metagenomics study to study the bacteriology of pleural infection. the investigators will use pleural fluid specimens from a) the "prospective validation of the rapid clinical risk prediction score in adult patients with pleural infection: the pilot study" (3) clinical trial and b) non-pleural infection patients. the pleural fluid specimens will be subjected to 16s rrna next generation sequencing.

pleural infection (pi) is a common, severe and complicated disease with considerable morbidity and mortality1,2. patients develop pleural effusions of frankly infected fluid. the understanding of pleural infection microbiome could improve patient clinical management, however the knowledge remains incomplete. sequencing of the bacterial 16s rrna gene is a reliable methodology to discovery the total microbiome of complex samples. the investigators designed a translational study to study the bacteriology of pleural infection. pleural fluid specimens from a) the "prospective validation of the rapid clinical risk prediction score in adult patients with pleural infection: the pilot study" (3) clinical trial and b) non-pleural infection patients will be subjected to bacterial dna extraction followed by 16s rrna next generation sequencing. moreover, the investigators will study the association between bacterial patterns and important clinical outcomes including survival, duration of hospitalisation and need for surgery.

Eligibility criteria:
the pleural fluid specimens were collected for the "prospective validation of the rapid clinical risk prediction score in adult patients with pleural infection: the pilot study". pmid: 32675200 doi: 10.1183/13993003.00130-2020. the investigators analysed the samples retrospectively. inclusion criteria: * as per protocol of the "prospective validation of the rapid clinical risk prediction score in adult patients with pleural infection: the pilot study". pmid: 32675200 doi: 10.1183/13993003.00130-2020 exclusion criteria: * as per protocol of the "prospective validation of the rapid clinical risk prediction score in adult patients with pleural infection: the pilot study". pmid: 32675200 doi: 10.1183/13993003.00130-2020

Keywords: pleural pleural infection pleural effusion microbiome metagenomics
multiple ascending dose study of trn-157 in stable mild and moderate asthmatics

Conditions: Asthma

Summary: this multiple ascending dose study is to determine the safety and bronchodilator activity of trn-157 in 59 mild and moderate asthmatics.


Eligibility criteria:
inclusion criteria: patients who meet the following criteria will be considered eligible to participate in the study: * the patient is ≥ 18 and \< 70 years of age, and gives informed consent * clinical diagnosis of mild to moderate asthma of at least 6 months duration and age of onset \< 50 years * presently using ics at moderate doses (equivalent to 200-800 µg of budesonide or 88-500 µg of fluticasone daily) * ≥ 12% and ≥ 200 ml improvement in fev1 to 4 puffs albuterol by metered-dose inhaler (mdi) at screening visit * patient is willing to use acceptable form of birth control during trial and for one month thereafter * ability to measure morning (am) peak expiratory flow (pef) on schedule using electronic peak flow meter (epfm) and to complete the study diary correctly at least 70% of the time during the run-in period * after 7 day withdrawal from laba therapy and overnight withdrawal from saba therapy (except rescue medication), patient has between 55% - 80% of predicted fev1 at cv2 exclusion criteria: a patient meeting any of the following criteria is not eligible for enrollment in the study: * a clinical diagnosis of chronic obstructive pulmonary disease (copd), chronic bronchitis, bronchiectasis, or other significant pulmonary disease other than asthma * history of upper or lower respiratory infection within 4 weeks of screening * history of asthma exacerbation requiring oral or systemic corticosteroids or hospital admission within 6 months of screening * history of myocardial infarction, or cardiac conduction abnormalities, including but not limited to atrial fibrillation, and paroxysmal atrial tachycardia * hospitalization due to cardiac failure within the last 6 months * history of narrow angle glaucoma or obstructive uropathy * current smokers or vapers, or former smokers with \> 10 pack-year (self-reported) history of smoking * patients who presently use the following medications will not be eligible for participation: * long-acting muscarinic receptor antagonist (lama) * laba (but may be withdrawn and converted to saba x 7 days prior to entry) * leukotriene pathway blockers * anti-ige antibody (xolair) within last 6 months prior to cv1 * phosphodiesterase 4 (pde4) inhibitors (e.g., roflumilast) * cromolyn * methylxanthines (e.g., aminophylline and theophylline) * 5-lipoxygenase inhibitor (e.g., zileuton) * allergies to lama therapies * history of life-threatening asthma exacerbation requiring icu admission, mechanical ventilation, or tracheostomy
assessment of bone mineral density in patients with subclinical hypothyroidism

Conditions: Subclinical hypothyroïdism

Summary: this study aims to recognize the effects of subclinical hypothyroidism on bone mineral density, not many studies were done on this subject

a lot of different factors are necessary for the harmonious development as well as normal functioning of skeleton: genetic conditions, hormonal and metabolic homeostasis, balanced diet, mechanical load. any disturbances of those agents can lead to serious and dangerous consequences like length reduction, deformations, and fractures. their results depend, between other, on one's age, type of disorder and its duration. * there are a lot of endocrinological reasons of secondary osteoporosis (for example: cushing's syndrome, hyperparathyroidism, hypogonadism, acromegaly, diabetes mellitus, hypothyroidism etc.. any changes of normal thyroid function and thyroid stimulating hormones (tsh) directly affects the remodeling of bone through tsh receptor found on osteoblast and osteoclast precursor cells. tsh has a positive correlation with body mass index (bmi) in women; though, this correlation is insignificant in male. women having subclinical hypothyroidism have reduced femoral neck bone mineral density (bmd). the variations in thyroid function are primary, while changes in body weight and bones are secondary. the physiological variation of thyroid hormones is associated with changes in bmd and non vertebral fracture risk in healthy postmenopausal women. the definition of osteoporosis by the world health organization (who) is densitometric and non-clinical and is based on the measurement of bone mass and dexa method in the spine or hip. there is still controversy about the relation between thyroid hormones, osteoporosis and bmd in female hypothyroid patients. this study aims to fill the gaps in our understanding of impact of subclinical hypothyroid disorder on bone densitometry.

Eligibility criteria:
inclusion criteria: - all adult patients with subclinical hypothyroidism with the level of tsh values above 4.0 mu/l.and normal values of thyroxine (t4) and triiodothyronine (t3). exclusion criteria: * diabetes mellitus * cushing * hyperparathrodisim * ckd .patients on corticosteroid therapy. * inflammatory conditions as rheumatoid arthritis,systemic lupus, crohn's disease, ulcerative colitis * haematological conditions as multiple myeloma, myeloproliferative disorders * vitamin d deficiency * males aged more than 55 years old * postmenopausal females will also be excluded in this study
value of mri csf flowmetry in assessment of grey zone hydrocephalic patients

Conditions: Hydrocephalus

Summary: to evaluate accuracy of (mri) cerebrospinal fluid flowmetry after shunt operation in patients with borderline (grey zone) hydrocephalus.

hydrocephalus could be defined as disturbance of formation, flow or absorption of csf. we encounter some challenging cases with intermittent non specific symptoms as delayed milestones and headache with concomitant imaging showing dilated ventricular system, so we find ourselves hesitating to take the decision of surgical intervention to put shunt or not, therefore mri csf flowmetry gives us a chance to overcome this problem. phase contrast mr imaging is a rapid, simple and non-invasive technique which is sensitive to even small csf flows, and can be used to evaluate csf flow both qualitatively and quantitatively. csf flow measurement at the suspected level of obstruction gives reliable and reproducible results for more accurate diagnosis and can be used to guide therapeutic decisions in a more reliable manner, and follow up post treatment outcome. with the ct and magnetic resonance imaging (mri) techniques, it is possible to localize with accuracy the exact site of blockage of flow to csf. hence classification is as follows: the hydrocephalus may be due to 1) overproduction of csf 2) obstructive 3) absorption defect. depending on the exact aetiology, a secondary classification could be added under the following headings: 1) congenital, 2) acquired, eg; traumatic inflammatory, neoplastic, and degenerative . bypassing the site of obstruction to csf flow by diverting the csf from ventricular cavity to a site where it is readily absorbed is the basic principle underlying the treatment of hydrocephalus. extensive range of complications has been reported for shunting for hydrocephalus. they could be classified as mechanical or flow-related complications as csf over drainage leading to subdural hematoma, subdural collections, low-pressure headaches cranial deformity, and asymmetrical drainage can lead to trapping or isolation of a part of a ventricular system. the slit ventricular syndrome is a complication related to absorption. besides, ascites, loculations, hydrocele, perforation of the stomach, large and small bowel are also described. the success rates of shunt operation for hydrocephalus depend on the age of the patient and the reason why the shunt is needed. generally, there is around a 50% failure rate for ventriculoperitoneal shunts.

Eligibility criteria:
inclusion criteria: patients with borderline hydrocephalus * clinically:suspicious and non specific symptoms as * headache * macrocranium * vomiting * gait instability * dementia * urine incontinence. * delayed milestone. * radiologicaly: dilated ventricular system. exclusion criteria: * documented or clinically and radiologically evident cases of hydrocephalus * patients known to have contraindications for mri, e.g. an implanted magnetic device, pacemakers or claustrophobia.
assessment of chronic guillain-barre syndrome improvement with use of 4-aminopyridine

Conditions: Guillain-Barre Syndrome

Summary: in developed countries, guillain-barre syndrome (gbs) is the most common cause of acute neuromuscular paralysis, afflicting about 5,000 persons annually in the united states. over 20% of gbs patients have permanent residual motor deficits that affect their activities of daily living. the goal of this study is to assess the potential usefulness and safety of 4-aminopyridine (4-ap) in those patients who suffer chronic functional deficits from gbs.this medication is a potassium channel blocker that has the potential to improve nerve conduction, particularly across partially demyelinated axons. it is felt that by increasing nerve conduction there will be improved motor performance for walking and activities of daily living, as well as decreased fatiguability. this medication has demonstrated potential usefulness in central demyelinating diseases such as multiple sclerosis.because the peripheral nervous system is much more accessible to systemic medication delivery it is felt that this medication may improve the functional status of those patients who are suffering from the residual side effects of this medication.

objective.- to determine the safety and efficacy of orally delivered 4-aminopyridine for motor weakness due to guillain-barre syndrome (gbs) under a fda approved protocol (ind no: 58,029). setting.- tertiary care outpatient rehabilitation center directly attached to a university hospital. subjects.- subjects who are unable to ambulate more than 200 feet without assistive devices and have residual nonprogressive motor weakness due to gbs more than one year out from the initial episode. design.- subjects will be randomized to a double-blind, placebo-controlled, cross-over design, which had two eight-week treatment arms with a three-week washout. the average dosage at 4 weeks will be 30 milligrams (mg) per day. patients who demonstrate improvement will be continued on the medication for an additional three months. assessments will be performed every two weeks during the randomized trial and every month for those continued for up to three months on the medication.

Eligibility criteria:
inclusion criteria * male or female, 19 to 75 years of age, irrespective of race. * subject is able to and has voluntarily given informed consent prior to the performance of any study specific procedures. * subject has neurological impairment secondary to gbs, which has been stable for more than 12 months. * subject has motor strength that averages less than 5.0 but greater than 3.0 on the asia motor scale. * subject is able and willing to comply with protocol. * subjects will agree to no change in their outpatient therapy, or home exercise programs during enrollment in the study.

Keywords: guillain barre syndrome 4-aminopyridine
pictou county pep: a 6-month, home-based, personal empowerment program for adults with a chronic medical condition living in pictou county

Conditions: Chronic Condition

Summary: the pictou county personal empowerment program is a comprehensive health promotion program aiming to improve the quality of life as well as both physical and mental health in adults living with chronic medical conditions. the program includes daily email communications over 6 months that encourage a range of self-management and health promoting activities, including strength and aerobic exercise, yoga, stress reduction techniques, dietary improvements, relationship/intimacy education and more.


Eligibility criteria:
inclusion criteria: * age \>18; * diagnosed with one or more chronic medical conditions, as per the participant's report, including but not restricted to the following (complete list in protocol appendix): * heart disease / cardiovascular disease / stroke * high blood pressure * diabetes including a diagnosis of pre-diabetes * chronic respiratory disease * chronic neurologic disease * chronic kidney disease * chronic liver disease * immunodeficiency * overweight or obese (bmi \>25) * psychiatric or mental health issue - e.g., depression and anxiety * substance-related and addictive disorders (e.g alcohol, smoking, etc.); * resident of pictou county, nova scotia; * existing (or willingness to create) email account and willingness to access email daily; * ability to follow website links to watch youtube videos; * ability to understand and speak english; * ability to participate in low to moderate levels of physical activity and strength training; * ability and willingness to fill out an online survey at baseline, and 6, 12 months, and fill in a weekly compliance survey for the six months of the program. exclusion criteria: * diagnosed with cancer in the last 5 years and/or received treatment for cancer in the last 5 years; * myocardial infarction or stroke within the last year and without written approval from their family physician, cardiologist, or study physician that they are safe to exercise; * unable to access the internet daily during the intervention; * lack of access to a computer or smartphone to receive emails required for study intervention.
impact of duration of untreated manic episodes on clinical outcome

Conditions: Patients Diagnosed With Bipolar Disorder ( Manic Episodes) and Delayed Diagnosis

Summary: the current study is cross sectional retrospective study, included 100 patients were diagnosed as mood disorder bipolar i (manic episodes) according to dsm5, patients recruited from inpatient psychiatric unit at department of neurology and psychiatry, assiut university hospitals the current work is designed to study the effect of duration of untreated bipolar disorder on clinical outcome ( severity , residual symptoms ,duration of hospital admission) and to study factors affecting duration of untreatment in upper egypt.

mood disorder carries a major burden in our country as it represents 15% of inpatients and 20% of outpatients in mental hospitals in egypt the current work is designed to study the effect of duration of untreated bipolar disorder on clinical outcome ( severity , residual symptoms ,duration of hospital admission) and to study factors affecting duration of untreatment in upper egypt. the current study is cross sectional retrospective study, included 100 patients were diagnosed as mood disorder bipolar i (manic episodes) according to dsm5, patients recruited from inpatient psychiatric unit at department of neurology and psychiatry, assiut university hospitals

Eligibility criteria:
inclusion criteria: * -age group between 18 to 45 years old. * patients diagnosed as mood disorder bipolar i manic episode according to dsm v(2). * clearly consenting to participate in the study. exclusion criteria: * -mood disorder due to substance abuse. * patients in depressive episodes. * other mental disorders
effect of mk0524a on cholesterol levels (0524a-048)

Conditions: Hypercholesterolemia; Hyperlipidemia

Summary: the primary objective of the study is to assess the effects of mk0524a in reducing cholesterol levels in an asian population.


Eligibility criteria:
inclusion criteria: * patient is male or female between 18 and 70 years of age * females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study exclusion criteria: * patient has a history of not being able to take niacin or niacin-containing products * patient consumes more than 2 alcoholic beverages per day * patient has poorly controlled type 1 or type 2 diabetes mellitus * patient engages in vigorous exercise or an aggressive diet regimen

Keywords: high cholesterol excess lipids
comparison of two steroid nasal implants following endoscopic sinus surgery for chronic rhinosinusitis

Conditions: Chronic Sinusitis; Rhinosinusitis

Summary: the purpose of this study is to learn whether there is a difference in postoperative (after surgery) endoscopic appearance of the sinus cavities (the way that the sinuses look through a camera) between sinuses that receive one of two types of resorbable steroid eluting sinus packing (a sponge-like material which dissolves within several days while releasing a steroid): 1) propel implant or 2) nasopore soaked with triamcinolone at the time of endoscopic sinus surgery (ess) for chronic rhinosinusitis.

1. the propel 'implant' is composed of small, flexible tubes which dissolve while releasing mometasone which is one type of steroid. this application has been approved for use by the fda. 2. nasopore soaked with triamcinolone. this "packing' is a sponge-like material which dissolves while releasing triamcinolone, which is another type of steroid. triamcinolone has been approved for use topically elsewhere on the body, although the specific use of triamcinolone in the sinuses has not been approved by the fda. both of these procedures are currently used regularly by dr. pearlman in practice at the conclusion of ess for treatment of chronic rhinosinusitis. as standard of care, treatment is determined intraoperatively (during surgery), at the discretion of the surgeon. in this study, each subject will have both treatments (one in each cavity). the 'experimental' aspect relates to directly comparing the two procedures. this research study is being done because there is currently a lack of consensus regarding the optimal nasal packing regimen. there have been no comparison studies and practice patterns vary widely. our study looks to compare the propel implant to nasopore packing soaked in triamcinolone.

Eligibility criteria:
inclusion criteria: -adult patients undergoing endoscopic sinus surgery for the treatment of chronic rhinosinusitis refractory to medical management exclusion criteria: * patients ineligible for informed consent * patients unwilling or unable to comply with the postoperative visits necessary for data collection * patients with a history of intolerance to triamcinolone * patients with suspected systemic inflammatory disease, cystic fibrosis, and any contraindication to systemic corticosteroids. * as standard of care, the pi does not operate on pregnant patients. a pregnant patient would not be a candidate for the study.

Keywords: propel implant nasopore triamcinolone