Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of dexmedetomidine during prolonged infusion in icu

Conditions: Pharmacokinetics; Sedation

Summary: the study will examine dexmedetomidine levels in the blood of critically ill intensive care patients to understand how it is broken down by the body.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from the patient's legal representative according to local regulations before starting any study procedures other than pre-screening * patients sedated and ventilated in icu for whom sedation is expected to be clinically required for at least 24 hours, as determined by the responsible physician * prescribed light to moderate sedation (target rass = 0 to -3) exclusion criteria: * acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury * uncompensated acute circulatory failure at screening (severe hypotension with mean arterial pressure(map) \< 55 mmhg despite vasopressor and inotrope therapy) * heart rate (hr) \< 50 beats/min for longer than 5 min between screening and starting study treatment * atrioventricular (av)-conduction block ii-iii (unless pacemaker installed) * severe hepatic impairment (e.g. bilirubin \> 101 μmol/l) * need for continuous muscle relaxation * any condition which would significantly interfere with the collection of study data * burn injuries or other conditions requiring regular anesthesia or surgery * use of centrally acting alpha-2 agonists or antagonists within 24 hours prior to starting the study (e.g. dexmedetomidine, clonidine, tizanidine, apraclonidine and brimonidine) * known allergy to dexmedetomidine or any excipients of the study treatment * patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis * patients receiving sedation for therapeutic indications rather than to tolerate the ventilator (e.g. epilepsy) * patients unlikely to require continuous sedation during mechanical ventilation (e.g. guillain-barré syndrome) * patients who are unlikely to be weaned from mechanical ventilation; e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or advanced amyotrophic lateral sclerosis)
long head of biceps as an anterior dynamic sling for recurrent anterior shoulder dislocation

Conditions: Shoulder Dislocation

Summary: purpose: to evaluate the functional outcomes of arthroscopic onlay dynamic anterior stabilization (das) using the long head of biceps (lhb) tendon for treatment of anterior glenohumeral instability (agi) with limited to subcritical glenoid bone loss (gbl).

twenty-five patients underwent arthroscopic das using lhb between march 2022 and october 2022 for treatment of anterior glenohumeral instability (agi) with limited to subcritical glenoid bone loss (gbl) were included in a prospective study with a minimum follow-up period of 2 years. the shoulder functional outcomes were assessed using the rowe and the quick disabilities of arm, shoulder and hand (quick dash) scores both preoperative and at 2 years follow-up. magnetic resonance imaging (mri) at 6 months after surgery to evaluate lhb tendon healing to the anterior glenoid.

Eligibility criteria:
the inclusion criteria were * patients complaining of agi, with one or more events of anterior shoulder dislocation. * associated limited (\<13.5%) to subcritical (\<25%) gbl. * positive anterior shoulder apprehension. the exclusion criteria were * associated critical gbl (≥25%). * concomitant lhb lesion or rupture. * multidirectional or voluntary shoulder instability. * prior arthroscopic shoulder stabilization procedure. * concomitant rotator cuff tears. * acute proximal humerus fractures of the involved shoulder.

Keywords: dynamic anterior stabilization; onlay; glenohumeral instability.
predictive factors for successful outcome after pulmonary veins ablation to treat paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation is the most common serious abnormal heart rhythm affecting about 2% to 3% of the population, being associated with a 1.5- to 1.9-fold higher risk of death. patients with paroxysmal af in whom antiarrhythmic drug therapy does not elicit a response are potential candidates for rf ablation of af. the success rate of rf ablation in the treatment of af varies depending on the type and duration of af (ie, paroxysmal vs persistent), structural remodeling of the heart, co-morbidities and the technique of the cardiac electrophysiologist, but it usually ranges from 60-80% over 1-2 years of follow-up. to study and predict the successful outcome of rf ablation is of great clinical importance. moreover, the detection of predictive factors for successful outcome may alter the therapeutic strategy determining a subgroup of patients in the need of more invasive management.

the study will include 150 patients scheduled to undergo pulmonary vein (pv) ablation because of non-responsive to medical therapy paf. ecg recordings will be obtained during sinus rhythm before and after pv ablation with a 3 - channel digital recorder for 10 minutes, and digitized with a 16-bit accuracy at a sampling rate of 1000 hz. the p wave will be analyzed using the morlet wavelet. other parameters to be analyzed include 12 lead surface ecg, the burden of main and secondary morphologies and echocardiographic indexes of left atrial mechanical function. follow-up visits will be held in 3, 6 and 12 months after the ablation procedure.

Eligibility criteria:
inclusion criteria: * males and females * age \>18 years * paroxysmal af (paf) scheduled to undergo pulmonary vein (pv) ablation * singed written consent form * patients who will comply with study procedures exclusion criteria: * age \<18 years permanent atrial fibrillation * acute myocardial infraction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within less than 2 months prior to ablation procedure * life expectancy less than 12 months, according to investigator's judgment * participation to other clinical trial * patients who will not be compliant with study procedures

Keywords: pulmonary veins ablation paroxysmal atrial fibrillation
quality of life assessed with the pah sympact questionnaire

Conditions: Pulmonary Hypertension

Summary: researchers are evaluating quality of life in pulmonary hypertension subjects using the pulmonary arterial hypertension-symptoms and impact (pah-sympact) questionnaire and assessing the questionnaires' performance with regard to relationship to other markers of disease severity, response to treatment, and outcome in a clinical practice setting.

subjects will be recruited from among those seen at the mayo pulmonary hypertension clinic. the pah-sympact questionnaire will be administered either in written form or by telephone interview. on the second 100 patients implement a standardized palliative care referral program for patients with group 1 and 3 ph and high sympact scores\> 1.0.

Eligibility criteria:
inclusion criteria: * age 18 years or above * consents to participate * documented group i pah based upon these hemodynamic criteria: (mpap \> 20, pcw 18 or less, pvr \> 3 wood units * mean pap \> 20, pcw ≤ 18, pvr \> 3 wood units * parenchymal lung disease that in the opinion of the investigator qualifies patient as group iii ph * documented chronic thromboembolic pulmonary hypertension or chronic thromboembolic disease with intent to treat with surgery, balloon pulmonary angioplasty, and/or ph medication exclusion criteria: * left sided heart disease (lvef\ 18) * any other known concomitant life-threatening disease with a life expectancy \<12 months * any other clinically relevant and/or serious chronic medical condition that would affect study participation in the opinion of the investigator * non english speaking
a provocation study using biogenic amines to show the efficacy of oral diamine oxidase supplementation

Conditions: Histamine Intolerance

Summary: this study aims to define a provocation test for histamine intolerance (aka. biogenic amine intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate this condition.

the clinical picture of the so-called histamine intolerance has been described by various authors since the 1990ies. however, the existence of this multifactorial condition is also being contested due to the lack of both a positive definition and unambiguous diagnostics. various provocation studies using pure histamine or histamine-containing foods support the existence of the disease pattern, however many questions still remain open. a lack of diamine oxidase (dao) is considered the etiological cause of the condition. dao is an enzyme known to degrade a wide array of biogenic amines. the aim of this study is to provoke a response in patients by oral administration of a defined mixture of biogenic amines. by administration of dao before provocation an attenuation of the symptoms is to be expected.

Eligibility criteria:
inclusion criteria: * persons suspected of suffering from bais (bais score ≥ 50) according the the questionaire used for histamine intolerance so far exclusion criteria: * pregnancy * coronary heart disease * labile hypertension * bronchial asthma * periodical therapy using h1-blockers * chirurgical intervention with the gi tract within the previous 3 months * participation in a clinical trial within the previous 4 weeks

Keywords: histamine, biogenic amines, diamine oxidase
relationship between 24-hour iop pattern and the 24-hour blood pressure pattern in patients with poag

Conditions: Primary Open Angle Glaucoma; Normal Tension Glaucoma

Summary: interplay between the increasing iop and decreasing blood pressure (bp) during the 24-hour period, especially in the nocturnal period, may lead to insufficient perfusion pressure of the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. patients with progressive vf loss showed greater nocturnal bp dips than patients with stable vf. reduced mean intraocular perfusion pressure (iopp) was significantly associated with the extent of glaucomatous damage. how the nycthemeral iop fluctuation influences glaucoma progression has not been studied in a prospective manner and remains to be elucidated. the purpose of this study is to assess the relationship between the 24-hour iop fluctuation pattern and the 24-hour bp pattern in patients with primary open angle glaucoma (poag). iop fluctuations will be monitored with sensimed triggerfish®, a portable investigational device using a contact lens sensor that monitors the iop fluctuation continuously over 24-hours.


Eligibility criteria:
inclusion criteria: * diagnosis of poag, including progressing normal tension glaucoma (ntg) based on recent or recurrent disc haemorrhage * no anti-glaucomatous drug treatment or washed-out for a period of 4 weeks prior to sd0 and absent throughout the study * aged more than 18 years, of either sex * not more than 4 diopters spherical equivalent on both eyes * not more than 2 diopters cylinder equivalent on both eyes * have given written informed consent, prior to pre-study screening exclusion criteria: * patients with history of ocular surgery within the last 3 months * corneal or conjunctival abnormality hindering contact lens adaptation * severe dry eye * secondary forms of oag * patients with systemic hypertension * patients with allergy to corneal anesthetic * patients with contraindications for silicone contact lens wear * wear of full frame metallic glasses during triggerfish® monitoring * patients not able to understand the character and individual consequences of the investigation * simultaneous participation in other clinical research

Keywords: glaucoma iop blood pressure ecg
doripenem in the treatment of complicated lower urinary tract infection or pyelonephritis

Conditions: Urinary Tract Infections; Pyelonephritis

Summary: the purpose of this study is to compare the microbiological cure rate of doripenem versus a comparator antibiotic in the treatment of patients with complicated urinary tract infection or pyelonephritis. the study will also characterize the safety and tolerability of treatment with doripenem in patients with complicated urinary tract infection or pyelonephritis.

doripenem is an antibiotic medication not yet approved by the us fda. this is a phase 3, multi-center, randomized, prospective, double-blind study of doripenem versus comparator in the treatment of complicated lower urinary tract infections (uti) or pyelonephritis in adults. after the screening, patients are randomized to receive either doripenem or comparator. patients are hospitalized, but subsequently, patients may be treated as outpatient or through home-based therapy at the investigators' discretion. conventional laboratory data are collected from all patients at specified times throughout the study. the primary endpoint is microbiological response measured at test of cure visit. the patients receive either doripenum or comparator; duration of therapy is 10 days.

Eligibility criteria:
inclusion criteria: * diagnosis of complicated lower urinary tract infection or pyelonephritis exclusion criteria: * women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control * history of moderate or severe hypersensitivity reactions to antibiotic medications

Keywords: complicated urinary tract infection pyelonephritis
prostatic artery embolization for the treatment of symptomatic benign prostatic hyperplasia (bph)

Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Summary: this is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (pae) for the treatment of moderate to severe lower urinary tract symptoms (luts) due to benign prostatic hyperplasia (bph). embolization will be performed with lc bead lumi particles using a balloon occlusion microcatheter or standard microcatheter.


Eligibility criteria:
inclusion criteria: * age ≥ 45 years and ≤ 85 years old * prostate volume ≥ 40 ml and ≤ 300 ml * diagnosis of bph with moderate to severe lower urinary tract symptoms (luts) * refractory or intolerant to medical management * ineligibility for or refusal of surgical management * no evidence of prostate cancer exclusion criteria: * history of pelvic cancer * neurogenic bladder disorder * bladder diverticula greater than 5 cm or bladder stones * acute urinary retention with foley catheter dependence * active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months * prior surgical prostate intervention * active participation in another clinical trial

Keywords: benign prostatic hyperplasia (bph) prostatic artery embolization (pae) lower urinary tract symptoms (luts) prostate artery embolization
a study of tocilizumab in patients with active polyarticular juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: this 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. in part i of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients \< 30kg) every 4 weeks for 16 weeks. in part ii of the study, patients with an adequate response in part i were randomized to receive either tocilizumab at the same dose as in part i or placebo every 4 weeks for up to 24 weeks. in part iii of the study, patients received tocilizumab at the same dose as in part i every 4 weeks for up to another 64 weeks. standard of care therapy with or without non-steroidal anti-inflammatory drugs (nsaid), corticosteroids, or methotrexate was continued throughout the study.


Eligibility criteria:
inclusion criteria: * children/juveniles, 2-17 years of age. * polyarticular-course juvenile idiopathic arthritis (pcjia) ≥ 6 months duration. * active disease (≥ 5 active joints, ≥ 3 with limitation of motion). * inadequate response to or inability to tolerate methotrexate. * methotrexate, oral corticosteroids, and non-steroidal anti-inflammatory drugs (nsaid) at stable dose(at least 8, 4, and 2 weeks,respectively) prior to baseline. * biologics discontinued, between at least 1 and 20 weeks prior to baseline, depending on biologic. exclusion criteria: * auto-immune, rheumatic disease or overlap syndrome other than pcjia. * wheelchair bound or bedridden. * intra-articular, intramuscular, intravenous, or long-acting corticosteroids within 4 weeks prior to baseline. * disease-modifying anti-rheumatic drugs (dmard) (other than methotrexate) within 4 weeks prior to baseline. * previous treatment with tocilizumab.
anticoagulation for aortic bioprosthesis (antipro)

Conditions: Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve Insufficiency; Aortic Valve Regurgitation

Summary: this study evaluates the clinical and hemodynamic outcome in patients after aortic valve replacement. half of the patients will receive warfarin + aspirin and the other half will receive only aspirin. the investigators will focus mainly on early bioprosthesis degeneration.

aortic bioprosthesis have the advantage that they do not require life-long anticoagulation. current guidelines support the use of aspirin (aas) 100 mg as a class i indication. current evidence, mainly derived from transaortic valve implantation (tavi) patients, have shown that aortic bioprosthesis suffer subclinical thrombosis which may explain the increase in gradient and bioprosthetic degeneration. anticoagulation in this cases improve leaflet mobility and decrease in gradient. evidence supporting early anticoagulation in patients with aortic bioprosthesis is not as strong as in the case of mitral bioprosthesis. nonetheless, current american heart association/american college of cardiology (aha/acc) guidelines recommend (iia) the use of warfarin for at least 3 months after aortic valve replacement. the aim is to conduct a single blinded (echocardiographist) randomized control study in patients who receive an aortic bioprosthesis. comparison will be performed between the use of warfarin + aspirin vs aspirin alone. duration of anticoagulation will be for 3 months and patients follow-up for 1 year. clinical and echocardiographic evaluation will be performed in every patients. some patients will undergo positron emission tomography (pet-scan).

Eligibility criteria:
inclusion criteria: * patients with indication of aortic valve replacement with porcine bioprosthesis exclusion criteria: * concomitant mitral valve replacement * previous atrial fibrillation * previous use oral anticoagulation * contraindication for the use of oral anticoagulation (high risk of bleeding, intolerance, allergy) * jehovah witness * platelet count below 90,000. * liver disease

Keywords: aortic valve replacement bioprosthesis anticoagulation
trans-rectal ultrasound of the female pelvis for real-time mri-us fusion based needle tracking

Conditions: Uterine Cancer

Summary: the purpose of this study is to utilize transrectal ultrasound (trus) images of the intact and post-hysterectomy female pelvis in order to provide feasibility information for a magnetic resonance imaging (mri)-trus fusion based 3d needle navigation system for use in image guided brachytherapy. the fusion and needle guidance will be performed using eigen health's navigation system that currently provides targeted mr/ultrasound fusion based prostate biopsies utilizing a proprietary 3d semi-robotic navigation system.


Eligibility criteria:
inclusion criteria: * histologically proven invasive primary squamous, adenosquamous, or adenocarcinoma of the uterine cervix, (recurrent or medically inoperable) uterine adenocarcinoma. * treatment plan must include curative-intent definitive radiation that includes brachytherapy treatments with or without concurrent chemotherapy * adults ≥ 18 years of age * ecog performance status 0-2 exclusion criteria: * patients with active rectal bleeding or rectal ulcer
assessment of hand-grip in the prevention of postural orthostatic hypotension

Conditions: Orthostatic Hypotension

Summary: the study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension in 20 patients diagnosed with autonomic failure. five healthy subjects will be studied for comparison. the investigators will evaluate the subjects while on tilt table for 10 minutes and than while mounted from lying down to 70 degrees for additional 10 minutes. blood pressure, heart rate and symptoms will be continuously measured. first study will evaluate the blood pressure changes. second measure will include hand-grip maneuver 1 minute before the erect positon. trans cranial doppler will assess the intracranial blood flow during the position changes.

study 1: 10 minutes lying on the tilt table. performing tcd study at 10 minutes. raising the tilt table to 70 degrees. performing tcd study 5 minutes after tilting. measuring blood pressure and symptoms for 10 minutes. returning the tilt bed to supine position. study 2. in continue with study 1: 10 minutes lying on the tilt table. performing tcd study at 10 minutes. performing hand-grip at 50-70% grip force for 1 minute raising the tilt table to 70 degrees. performing tcd study 5 minutes after tilting. measuring blood pressure and symptoms for 10 minutes. returning the tilt bed to supine position.

Eligibility criteria:
inclusion criteria: * man or women * 18 years of age or older * diagnosed with orthostatic hypotension due to parkinson's disease, multiple system atrophy or pure autonomic failure * orthostatic hypotension is not due to drugs, any heart disorder, anemia or dehydration exclusion criteria: * pregnant or breast feeding
complementary and alternative medicine during the covid-19 pandemic

Conditions: Complementary Therapies

Summary: complementary and alternative medicine is frequently used in the treatment of several groups of diseases.

this study aimed to explore the attitudes of adults living in turkey toward complementary and alternative medicine in the period of the covid-19 pandemic and identify whether turkish adults used it during the pandemic.

Eligibility criteria:
inclusion criteria: * agree to participate in the study * not to be a communication problem exclusion criteria: * be a communication problem

Keywords: complementary therapies covid-19 complementary and alternative medicine attitude