Kornimate/medical-research-clean huggingface dataset:
pyrophosphate and arterial calcification in chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: arterial calcifications start at early stages of chronic kidney disease (ckd) and are associated to cardiovascular mortality. pyrophosphate (ppi) is an endogenous compound, which stops the mineralization process in bones and is expected to act at ectopic sites. in uremic rats, low ppi plasma levels are associated with high calcium content in the aorta and peritoneal administration of ppi blocks this process. people on maintenance dialysis or kidney transplant recipients have low plasma levels of ppi and show high scores of arterial calcification. the purpose is to determine the role of low ppi in the development of arterial calcifications in patients with ckd stage 3 or 4. to that aim, 252 patients with egfr between 59 et 20 ml/min/1,73 m2 will be recruited and will be examined at baseline and three years later.


Eligibility criteria:
inclusion criteria: * egfr between 59 et 20 ml/min/1,73 m2 twice at three month interval exclusion criteria: 1. kidney transplantation 2. acute inflammatory disease or active cancer
the pacing vs no pacing study - pnp study

Conditions: Aortic Valve Stenosis

Summary: pilot interventional study, without drug, randomized 1: 1, open-label comparison of efficacy and safety between the technique of percutaneous balloon aortic valvuloplasty without rapid ventricular pacing vs valvuloplasty during rapid ventricular pacing (using a temporary pacemaker device with ce mark). it is expected to enroll 100 patients. randomization is done through a dedicated computer program.

the aim is to compare, in terms of procedural success and safety, the procedure of percutaneous balloon aortic valvuloplasty (bav) without rapid ventricular pacing with the same procedure carried out with the aid of rapid ventricular pacing. it is a pilot study with the objective to enroll 100 consecutive patients matching inclusion and exclusion criteria who are randomized 1:1 in two arms: in the first patients undergo procedure of bav without rapid pacing, in the second bav with rapid ventricular pacing able to help in balloon stabilization during inflations. efficacy will be studied analysing changes in transvalvular gradient from baseline to post-bav. safety outcomes will be collected both at discharge and at 30-day. other procedural data will be object of direct comparison.

Eligibility criteria:
inclusion criteria: * diagnosis of severe symptomatic aortic valve stenosis. * no immediate indication to aortic valve replacement (avr). * indication to balloon aortic valvuloplasty (bav). * written expression of informed consent. exclusion criteria: * clinical presentation in cardiogenic shock at the time of bav. * clinical presentation in acute pulmonary edema not previously stabilized by medical therapy.

Keywords: balloon aortic valvuloplasty rapid ventricular pacing outcome
everyday practice with transcatheter aortic valve implantation

Conditions: Aortic Valve Stenosis

Summary: the purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.

the tavi program in our center started on november 2007. as part of the national policy for quality assurance in medicine a detailed clinical characterization of the tavi-population was required. furthermore, a detailed description of the procedure and peri-procedural complications until discharge was required. in our center we designed and are routinely using a tavi database which fulfills the authority requirements as well as has additional data needed for planning and documentation of tavi procedure. since there is already a considerable number of tavi patients in this database we aim to perform statistical analyses answering different question in this filed.

Eligibility criteria:
inclusion criteria: * aortic stenosis * intermediate-to-high risk for surgery * heart team decision exclusion criteria: * contraindication to transfemoral tavi procedure
thrombolytic therapy versus surgery for obstructive prosthetic valve thrombosis

Conditions: Obstructive Thrombus

Summary: prosthetic heart valve thrombosis is a serious complication with high mortality and morbidity the best treatment of pvt is controversial, although surgery and thrombolysis options have been available. in this randomized and multicenter study, the investigators compared thrombolytic therapy versus surgery for the treatment of patients with obstructive prosthetic valve thrombosis.

two different randomization group have been defined and patients with obstructive prosthetic valve thrombosis are included in each group randomly. in the first arm, thrombolytic therapy (tt) is performed to the patients with obstructive prosthetic valve thrombosis. the tt regimen depends on the functional status of the patient. in patients with nyha class iii-iv dyspnea low dose, relatively faster tt regimen (25 mg tpa/6 hours) is performed. in patients with nyha class i-ii dyspnea tt with low dose and ultra slow infusion of tpa (25 mg tpa/25 hours) is performed. during tt, patients are followed up with transesophageal echocardiography in every 24 hours. in the second arm, redo valve surgery is performed for obstructive valve thrombosis. this multicenter study is conducted in cardiology and cardiovascular surgery departments of kosuyolu kartal heart training and research hospital, istanbul, turkey, siyami ersek heart training and research hospital, istanbul, turkey, ankara heart training and research hospital, ankara, turkey, i̇zmir atatürk heart training and research hospital, i̇zmir, turkey, erzurum atatürk university faculty of medicine, erzurum, turkey, diyarbakır dicle university faculty of medicine, diyarbakır, turkey and kars kafkas university faculty of medicine, kars, turkey. informed consent is taken from all patients.

Eligibility criteria:
inclusion criteria: * obstructive prosthetic valve thrombosis exclusion criteria: * non-obstructive prosthetic valve thrombosis

Keywords: prosthetic valve thrombosis surgery thrombolytic therapy transesophageal echocardiography
vit45 versus oral iron in the treatment of anemia in non-dialysis dependent chronic kidney disease

Conditions: Anemia

Summary: this study compares the efficacy and safety of intravenous (iv) iron (vit45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (ndd-ckd).

this study compares the efficacy and safety of intravenous (iv) iron (vit45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (ndd-ckd).

Eligibility criteria:
inclusion criteria: * males or females \> or = 12 years of age * ndd-ckd subjects * baseline hemoglobin \< or = 11g/dl * stable erythropoietin (epo) status exclusion criteria: * known hypersensitivity to ferrous sulfate or iv iron * unstable epo status * anemia not related to ckd * chronic, serious infection * recent iv iron * recent blood transfusion * recent blood loss * need for surgery * received investigational drug within 30 days * female subjects who are pregnant or lactating

Keywords: anemia chronic kidney disease iron
evaluation of the prepex device for rapid scale-up of vmmc, phase 3 field implementation trial with hiv + adult males

Conditions: HIV Seropositivity

Summary: this study will assess the safety of the prepex device as applied to hiv positive men by assessing the rate of clinical adverse events. the study will include adult, hiv + men who are eligible to receive the prepex procedure per the zimbabwe ministry of health and child care (mohcc) eligibility criteria.

according to mathematical modeling, voluntary medical male circumcision (vmmc) has the potential to have a major impact on reducing hiv incidence in areas with high hiv prevalence and low prevalence of male circumcision, as is the case in zimbabwe. male circumcision devices have the potential to accelerate vmmc scale-up as the procedure is faster and simpler and can be safely performed by nurses. however, fear of social stigma and desire to avoid hiv testing remain potential barriers to those hiv+ men who would otherwise seek out vmmc. study subjects (n=400) are hiv+ males who elect to undergo vmmc with prepex as a study subject, and healthcare workers involved in implementation of prepex on hiv+ male subjects. the aim of the study is to determine if prepex can be used safely among hiv+ men with similar rates of adverse events to hiv-uninfected men. if so, then the barrier of mandatory hiv testing as part of vmmc could be removed, encouraging more men to undergo the procedure. determining prepex safety in hiv+ men would also allow both those with unknown status and those with positive status to undergo mc with prepex. determining the barriers to performing vmmc among hiv+ men among healthcare workers, if any, would also inform future policy.

Eligibility criteria:
inclusion criteria: * agrees to take an hiv test * hiv sero-positive * who hiv clinical stage 1 or 2 * age 18 years and above * agrees to be circumcised by prepex * able to understand the study procedures and requirements * completes vmmc counseling * agrees to return to the health care facility for follow-up visits or as instructed after this circumcision until complete healing 7 weeks from device application, or until cleared by a physician * able to comprehend and freely give informed consent for study participation exclusion criteria: * known bleeding/coagulation abnormality (excessive bleeding from nosebleeds, pulled tooth, or gums) * uncontrolled diabetes (frequent treatment in a clinic or recent hospitalization for diabetes, frequent infections, hypertension, or kidney disease) * active genital infection, anatomic abnormality or any other condition, which in the opinion of the investigator prevents the subject from undergoing circumcision using prepex. * hiv sero-negative * hiv status unknown * who hiv stage 3 and above * does not agree to prepex

Keywords: prepex hiv seropositivity
effects of botulinum toxin type a(meditoxin®) on sleep bruxism

Conditions: Sleep Bruxism

Summary: the purpose of this study is to evaluate the effect of botulinum toxin type a(meditoxin®) on bruxism using polysomnography and determine which site is most appropriate for injection to obtain maximal effects.

bruxism is an oral habit consisting of involuntary non-functional gnashing, clenching, grinding of teeth and is a very common condition in the general population. various treatment modalities such as occlusal splints, pharmacologic agent and cognitive-behavioral therapy have been investigated for the management of bruxism, but none is reported to be fully effective. recently locally injected botulinum toxin has been used in various movement disorders, but its usefulness and objective effects on nocturnal bruxism have not been evaluated using objective measures such as polysomnography. moreover, there is no systematic study about which site is most appropriate for injection to obtain maximal effects. the aim of this study is to evaluate the effect of botulinum toxin type a into masseter muscle or both masseter muscle and temporal muscle on nocturnal bruxism using polysomnography and the changes in the bruxism events on polysomnography.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sleep bruxism confirmed by wear facets on occlusal splint * must be able to follow clinical trial procedure * who are suitable for this clinical trial * who participated in this clinical trial out of his own free will exclusion criteria: * who take medications such as benzodiazepine or muscle relaxants * who have secondary bruxism due to brain injury * who are pregnant or have the possibility of pregnancy * who had an botulinum toxin injection during the past three months * who had an allergic reaction history to botulinum toxin * who have an infection or skin trouble on injection site * who have an other treatment plan for bruxism * who are enrolled in other clinical trials * who are not suitable for this clinical trials * who have mandibular dyskinesia or mandibular dystonia

Keywords: bruxism polysomnography botulinum toxin type a masseter muscle temporal muscle
aortic root enlargement versus aortic root replacement in the management of cases with small aortic root

Conditions: Aortic Valve Disease

Summary: each type of aortic valve surgery has its advantages and disadvantages; we aim to differentiate between two types of aortic valve surgery: aortic root replacement (using either ross procedure or stentless bioprosthesis procedure) and mechanical aortic valve replacement.

aortic valve replacement has been performed since the 1950s. since then, the surgical procedure has been optimized to reduce the risk of procedure-related complications. in addition, technical advances in the design of valves have significantly improved long-term prognosis. after the initial use of mechanical ball-caged valves, numerous monoleaflet and bileaflet valves have been introduced and evaluated. moreover, bioprosthetic valves came on the market in the 1960s as an alternative to mechanical valve. the pulmonary autograft was introduced in clinical practice as a substitute for the diseased aortic valve by donald ross in 1967. the original implant technique, namely subcoronary freehand grafting, was associated with substantial prevalence of early and late valve dysfunction, thereby limiting widespread adoption of the operation. more recent experience with pulmonary autografts used for complete or partial aortic root replacement allowed for satisfactory functional behavior of the valve . homografts for aortic valve replacement were the first biologic stentless prostheses used in clinical practice in the 1960s. binet introduced a stentless porcine bioprosthesis, but the valve was abandoned because of poor tissue fixation. due to limited availability and a relatively difficult implantation technique, mechanical avr became the popular therapeutic option. the disadvantage of life-long anticoagulation therapy in mechanical avr prompted the development of xenogeneic bioprostheses. although porcine aortic valves or pericardial tissue mounted on a stent made the implantation technique easier, these valves sacrificed orifice area and increased stress at the attachment of the stent, which caused earlier primary tissue failure. optimizing hemodynamics to prevent patient-prosthetic mismatch and improve durability revived the use of stentless bioprostheses in the early 1990s. patients with an expected survival of less than 10 years (more than 65 years old, renal disease, lung disease, patients who are more than 60 years old), ejection fraction of less than 40%, or coronary disease would be reasonable candidates for aortic bioprostheses to avoid anticoagulation with an extremely low likelihood of aortic valve reoperation. results tend to favor mechanical aortic valves in patients under age 65 years with a life expectancy of at least 10 years.

Eligibility criteria:
inclusion criteria: * patients undergoing aortic valve surgery. exclusion criteria: * patients who have other procedure with aortic valve surgery.
prostate biopsy access needle & needle guide feasibility study

Conditions: Prostate Cancer

Summary: the objective of the study is to assess the design features of a modified stainless steel access needle (single use disposable) in a clinical setting and a disposable, single use, custom-made, polymer needle guide used in conjunction with a rectal ultrasound probe. the disposable stainless steel access needle may be used with or without the disposable needle guide, but will always be used with ultrasound image guidance and a biopsy gun. the primary purpose of the single-use disposable access needle is to guide the use of a biopsy gun to obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of the perineum. the primary purpose of the disposable needle guide is to stabilize the needle biopsy and better approximate the most direct path to the prostate.

the objective of the study is to assess the design features of a modified stainless steel access needle (single use disposable) in a clinical setting with and a disposable, single use, custom-made, polymer needle guide used in conjunction with a rectal ultrasound probe. the disposable stainless steel access needle may be used with or without the disposable needle guide, but will always be used with ultrasound image guidance and a biopsy gun. the primary purpose of the single-use disposable access needle is to guide the use of a biopsy gun to obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of the perineum. the primary purpose of the disposable needle guide is to stabilize the needle biopsy and better approximate the most direct path to the prostate. for some subjects, the study will assess the fit and functionality of the stainless steel access needle when used in conjunction with the disposable needle guide as well as multiple handling aspects of the access needle and disposable needle guide when utilized in a prostate biopsy procedure. the study will also assess the ability of trans-rectal ultrasound to appropriately image the stainless steel access needle and biopsy gun needle at, near, and within the prostate tissue.

Eligibility criteria:
inclusion criteria: * males requiring a needle-biopsy of the prostate with ultrasound assistance via a trans-rectal ultrasound probe * otherwise healthy patient with no serious acute or chronic illness exclusion criteria: * patients with a partial or complete prostectomy * patients with active infection of the prostate, perineum, rectum, bowel, or peritoneum * patients with serious acute or chronic illness * cannot read and comprehend simple instructions in english * poorly controlled psychiatric disease * females

Keywords: transperineal transrectal needle guide biopsy
osteopathic treatment to alcohol withdrawal syndrome

Conditions: Alcohol Withdrawal

Summary: the alcohol withdrawal syndrome has a hierarchical symptomatology depending on the severity (minor, moderate or severe). these signs express a state of psychic, behavioral and physical deprivation. the management of withdrawal syndrome involves the establishment of pharmacological and psychosocial interventions. osteopathy is an exclusively manual practice whose purpose is to overcome the dysfunction of mobility of tissues of the human body. it can be used as a complementary treatment when a specific support is put in place. the purpose of this study is to examine the effectiveness of osteopathy in reducing alcohol withdrawal symptoms in adult patients.

the use of osteopathic techniques for facial equilibration decreases the severity of withdrawal symptoms experienced by patients hospitalized in a weekday hospital.

Eligibility criteria:
inclusion criteria : * age\> 18 years * patient hospitalized for a programmed alcohol withdrawal * patient not abstinent with alcohol before hospitalization * signed informed consent exclusion criteria : * minor patient * patient with an addiction other than alcohol (except tobacco and benzodiazepines) * previous participation in the osteool study
obesity and the initiation of knee osteoarthritis

Conditions: Obesity

Summary: healthy adults aged 20-60 of varying weights will participate in this minimally invasive study. there is one 4-hour appointment for which subjects are paid $120. the tests involve: 1 tube blood draw, 1 gait test (motion capture) and 1 mr of both knees.

the tests will be done at the va and stanford and are not dangerous or painful. they are designed to help us learn more about the relationship of excess weight on cartilage degradation by testing a biomarker in blood. gait testing involves walking in a lab that is about 20 meters long about 20 times. mr involves lying in a tube for less than 1 hour.

Eligibility criteria:
inclusion criteria: * healthy adults aged 20-60 who have no history of le surgery * healthy adults able to walk 30 minutes * healthy adults able to have mr exclusion criteria: * adults who have had le surgery * adults cannot walk 30 minutes * adults who cannot tolerate mr * adults with osteoarthritis

Keywords: obesity arthritis
the neuroprotective effect of lamotrigine and interferon beta 1a in patients with relapsing-remitting multiple sclerosis

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: this study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis.


Eligibility criteria:
inclusion criteria: * definitive multiple sclerosis according to mc donald criteria * clinical isolated syndrome according to mc donald criteria * expanded disability status scale score 0-5 * pre-treatment with interferon beta 1a (avonex) since at least 2 months before inclusion exclusion criteria: * relapse within 30 days prior to randomisation * steroid pulse therapy within 30 days prior to randomisation * pregnancy or poor contraception * contraindication for lamotrigine * depressive symptoms * drugs with possible interaction with lamotrigine according to instruction leaflet * other medical relevant conditions but multiple sclerosis * clinically relevant laboratory results * contraindication for mri * missing informed consent

Keywords: neuroprotection multiple sclerosis brain atrophy mr-spectroscopy
pentacam study of the cornea in ra patients

Conditions: RA - Rheumatoid Arthritis

Summary: to evaluate the effect of rheumatoid arthritis (ra) activity on the corneal densitometry, corneal curvature (cc), central corneal thickness (cct), and lens densitometry by pentacam and compared these parameters with those of age-matched healthy control subjects

case - control observational study on ra patients which divided into 2 groups, each group 120 eyes of 60 patients, group 1 of ra in the remission state and group 2 of ra in the active state. group 3 of 120 eyes of healthy controls. pentacam was used to measure corneal densitometry, cc, cct, and lens densitometry. the cornea was divided into 4 concentric zones (0-2, 2-6, 6-10, and 10-12) and anterior, central, and posterior layers according to the depth

Eligibility criteria:
inclusion criteria: * the included patients had aged more than 20 years with ra only without ocular manifestations with clinically clear cornea with normal anterior and posterior segment examinations with normal intraocular pressure (iop) exclusion criteria: * we excluded patients with ocular problems as corneal opacity, cataract, glaucoma, errors of refraction, topical application of eye drops except for topical artificial tears. the presence of systemic diseases other than ra as dm, hypertension were also excluded

Keywords: pentacam-ra-corneal densitometry