Kornimate/medical-research-clean huggingface dataset:
randomized study on the effect of oesophageal temperature on the incidence of esophageal lesions after af ablation

Conditions: Cardiac Arrhythmias; Atrial Fibrillation; Esophageal Ulcer

Summary: it's a randomized pilot study to evaluate the incidence of esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation according to three different strategies of esophageal temperature monitoring. these patients will be divided into 3 groups with different strategies of esophageal temperature monitoring: group 1 without monitoring, group 2 monitoring with single probe thermometer and group 3 monitoring with multi-probe thermometer. the primary end point will be the incidence of esophageal lesions assessed by upper endoscopy.

this is a randomized pilot study on the effect of oesophageal temperature monitoring on the esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation (af). sixty patients with paroxysmal af or persistent and without previous af ablation with indication of af ablation will be selected to be included at the study. after informed consent, these patients will be randomized in 3 groups with different strategies of esophageal protection for radiofrequency application in the posterior wall of the left atrium, by randomization in a ratio of 1: 1: 1 between groups. group i: no esophageal temperature monitoring technique. group ii: monitoring of esophageal temperature during radiofrequency applications in the posterior wall of the left atrium, with unipolar thermometer. group iii: oesophageal temperature monitoring during radiofrequency applications in the posterior wall of the left atrium, with a multipolar and self expandable thermometer. the primary end point will be the incidence of esophageal lesions assessed by upper endoscopy that will be done in all patients.

Eligibility criteria:
inclusion criteria: * patients with paroxysmal or persistent af, diagnosed by electrocardiogram, 24-hour holter, or monitors of implantable or non-implantable events, with at least one episode of af up to 12 months before the procedure. patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form. exclusion criteria: * atrial thrombus in the left atrium, history of af ablation, history of cardiac surgery, contraindication to anticoagulation, permanent af, new york heart association functional class iii or iv, stroke in the last 3 months, pregnancy, history blood clotting abnormalities, previous oesophageal surgery, or advanced chronic kidney disease (creatinine \> 2.5 mg/dl).

Keywords: atrial-esophageal fistula radiofrequency ablation atrial fibrillation ablation
comparison of pain after uterine artery embolization using gelatin microsphere or tris-acryl gelatin microsphere

Conditions: Uterine Myoma; Uterine Fibroid

Summary: this study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using gelatin microsphere or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids.

this investigational study is designed to compare pain after uterine artery embolization using gelatin microsphere or tris-acryl gelatin microsphere in patients with symptomatic fibroids. the primary end-points will be evaluated by assessing the maximum visual analogue scale (vas) score obtained for each time points within 24 hours after embolization. secondary end-points consist of evaluating six items: 1) fentanyl and analgesic usage within 24 hours, 2) comparison of symptom severity score and health-related quality of life score, 3) comparison of postoperative inflammation, 4) assessment of tumor necrosis degree in magnetic resonance imaging, 5) fluoroscopy and procedure time comparison, and 6) assessment of residual ovarian function before and after surgery (serum amh). this study included patients between the ages of 20 and less than 60 years of age who were diagnosed with uterine myoma and planned to undergo uterine artery embolization.

Eligibility criteria:
inclusion criteria: * a patient aged between 20 and under 60 who decided to undergo uterine artery embolization for symptomatic uterine myoma. exclusion criteria: * bradycardia on electrocardiogram (\< 45 bpm) * ventricular conduction abnormalities * liver failure * kidney failure * uncontrolled high blood pressure * obesity (bmi ≥ 30 ㎏/㎡) * patients who are allergic to drugs * patients who cannot read consent forms such as illiterate or foreigners * pregnant woman
evaluation of pegfilgrastim for stem cell mobilization in children

Conditions: Solid Malignancies

Summary: hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state provides an efficient stem cell mobilization in children with malignancies design: phase 2 study. judgment criterion: percentage of children achieving at least 5x10e6 cd34 cells with a standard apheresis (less than 2 blood volume processed)

patients: consecutively referred for hsc mobilization. at least 17 days after the previous chemotherapy. no hematological growth factor during the 8 previous days. mobilization: one sc injection of 300 µg/kg pegfilgrastim (neulasta, amgen) evaluation during the study: cd34 circulating cells from day 2 to day 7 ; ae recording judgment criterion: percentage of children achieving at least 5x10e6 cd34 cells with a standard apheresis (less than 2 blood volume processed) analysis: sequential bayesian study

Eligibility criteria:
inclusion criteria: * 0 to 18 years * solid malignancy * lansky score \>70% * more than 17 days since the beginning of the last chemotherapy cycle * absolute neutrophil count (anc) greater than 1×109/l * no administration of any hematopoietic growth factor in the previous 8 days exclusion criteria: * clinical or biological conditions precluding the mobilization or collection procedure

Keywords: children cancer bone marrow transplantation mobilization g-csf children with solid malignancies
vitamin d and immunity: photosynthesis versus supplementation

Conditions: Vitamin D Deficiency

Summary: the optimal way to restore serum 25-hydroxyvitamin d sufficiency is currently debatable. uv irradiation through sunshine exposure promotes endogenous vitamin d synthesis, although this can also be associated with a risk of uvr-induced skin cancer. dietary supplements represent an alternative, which are increasingly being used in clinical trials to correct deficiency. however, it is unclear whether sunshine exposure and vitamin d supplementation induce comparable changes in immune function, or whether additional uvr-induced molecules may be responsible for proposed health benefits. several studies report an inverse correlation between exposure to uvr and immune-mediated diseases, further supporting the theory that uvr may also be protective through non vitamin-d mediated pathways. so far it has been difficult to distinguish between immune-regulation by vitamin d and other mediators induced by uvr as the downstream effects are similar. a direct comparison of the biological effects of vitamin d obtained by uvr versus supplementation has never been made. this study aims to elucidate the differences in vitamin d generated by uvr exposure versus supplementation by comparing immunological endpoints


Eligibility criteria:
inclusion criteria: * age: 18-40 * fitzpatrick skin type i/ii * healthy * serum 25(oh)d3 \<50nmol/l exclusion criteria: serum 25(oh)d3 \>50nmol/l * pregnant or nursing women * women of child bearing age not using adequate contraception * are taking photosensitizing medication (i.e. causes you to be more sensitive to sunlight) * have had a history of skin disorders, sensitive skin, sensitivity to sunlight or skin cancer * have previously had an organ transplant * have partaken in a clinical study within the last 14 days * have had recent exposure to sunbeds (last 4 months) or holiday sun (including skiing) * are currently or have taken vitamin d supplements in the last 4 months are asthmatic or suffer from any allergies

Keywords: vitamin d uvr immune system
study of the psychological development of children of parents with and without affective disorders

Conditions: Bipolar Disorder; Involutional Depression; Mood Disorder

Summary: this research study is the continuation of a study started more than 20 years ago. the study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance. the study will continue to investigate if children have certain characteristics in early and middle childhood that predict the later development of psychological disorders. in addition, the study will continue looking at the processes responsible for the development of children of parents with and without affective (mood) disorders.

the psychological development of offspring of parents with and without affective disorder is assessed from early childhood to young adulthood. parents with a diagnosis of major depression or bipolar illness and well parents and their children are studied (sads-l, rdc, and scid, dsm-iii). a sibling pair is studied in each family. parent-child interaction is investigated through direct observation of behavior in naturalistic and controlled settings. family history information is obtained through parent interviews. behavioral observations, standard tests, physical examinations, and psychiatric interviews, and mri procedures provide multiple assessments of the offspring. the study has been completed through preadolescence, adolescence, and late adolescence. follow-up in young adulthood continues.

Eligibility criteria:
patients will be drawn from an ongoing longitudinal study begun in 1979 of offspring of parents with affective illness (unipolar and bipolar) and children of normal control parents.

Keywords: parental psychopathology child rearing depression bipolar affective disorders manic-depression social-emotional development cognitive development child psychopathology affective disorder children at risk
peripheral blood mononuclear cells response in healthy controls, heavy drinkers, and patients with alcoholic hepatitis

Conditions: Alcoholic Hepatitis

Summary: inflammatory responses in response to alcohol have been identified as contributing to the development of alcoholic hepatitis. the inflammatory response including that to lippopolysaccharide is known to lead to progression of alcoholic liver disease. in addition to the inflammatory response mitochondrial perturbations exist and redox homeostasis is altered in patients with alcoholic hepatitis. though this is known there have been very few studies targeting mitochondrial function in peripheral blood mononuclear cells (pbmcs). we plan to collect 50 milliliters of blood from healthy control patients so that we can compare the data to that of patients with alcoholic hepatitis and those who are heavy drinkers without liver disease. in addition to studying mitochondrial function we will investigate cytokine response, as well as fatty acid metabolism, glucose, and insulin measurements


Eligibility criteria:
inclusion of subjects with alcoholic hepatitis (ah): \*diagnosis of ah either by imaging, biochemical values or liver biopsy as well as drinking history inclusion heavy drinking controls: \*heavy alcohol drinking will be defined as \>40 g/day or \>280g/week on average for women and \>60 g/day or \>420 g/week on average for men for a minimum of 6 months \[6\] and within the 4 weeks prior to study enrollment. exclusion criteria for all groups * inability or unwillingness to sign informed consent * cancer * autoimmune disease that in the opinion of the pi will confound study data control subjects (drinking and non drinking) must meet the following criteria: * inr \< 1.4 * total bilirubin levels must \<3 * no prior history of known alcoholic liver disease * absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease.
assessement of microcirculation with nirs predicts sepsis development in patients with severe covid-19 pneumonia

Conditions: Sepsis

Summary: sepsis and septic shock are among main causes of death in patients with severe covid-19 pneumonia. a few factors are proven to predict sepsis in these patients. with near infrared spectroscopy it is possible to detect microcirculatory changes typical for sepsis early in the course of disease. the hypothesis that changes in tissue oxygene saturation during vasoocclusive test predict sepsis as well as mortality in mechancally ventilated patients withe severe covid-19 pneumonia will be tested.

at the moment the majority of icu admissions in slovenia are due to severe covid19 pneumonia. despite intensive supportive treatment the mortality of these patients is high, around 30%. the main reason for icu admission is respiratory failure, these patients usually do not have multiorgan failure on admisssion. in the early phase of disease the inflamatory, endothelial and microcirculatory response is different than that in "classic" septic shock. one of the most common complications later in the course of severe covid19 pneumonia is sepsis, which is defined as a life threatening syndrome with the failure of one or more organs due to disregulated inflamatory host response. this definition can be connected to the majority of patients who die. it is not well known which factors predict sepsis development in patients with severe covid19 pneumnia. in a laboratory mode the coagulation abnormality have been shown to be one of them. one of the earliest features of sepsis are microcirculation dysfunction and oxygene consumption abnormalities. many studies have shown that with near infrared spectroscopy, we can reliably assess these abnormalities. with this method the tissue oxygene saturation can be measured. with vasoocclusive test the rate of tissue deoxygenation during stagnant ischemia and the rate of reoxygenation after flow release can be determined. it has been shown that the inclination of both curves decreases in sepsis. the measurements have also prognostic value. with the clinical study we want to detect the microcirculatory abnormalities, typical for sepsis, early in the course, before the clinical and laboratory signs of multiorgan failure develop. aim of the study is to test hypotheis that nirs measurements can predict sepsis development early and that machanically ventilated (due to covid 19 pneumonia) patients with microcirculatory abnormalities have worse prognosis than those with preserved microcirculatory function.

Eligibility criteria:
inclusion criteria: * severe respiratory failure due to covid19 pneumonia * sedated, mechanically ventilated patient exclusion criteria: * sepsis with multiorgan failure present on admisssion

Keywords: sepsis microcirculation nirs sarscov19
a phase i open label dose escalation trial of rna-144101 in the treatment of geographic atrophy

Conditions: Geographic Atrophy

Summary: this is a non-randomized, open-label, dose-escalating phase ia study performed at a single center designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of intravitreous administration of rna-144101 in patients with geographic atrophy (ga).


Eligibility criteria:
inclusion criteria: * males and females of all races and ethnicities between the ages of 50-99 * female subjects must be 1-year postmenopausal or surgically sterilized and must have negative serum pregnancy test * subjects must have ga from amd in one or both eyes: * the study eye will be the eye that meets all inclusion/exclusion criteria * if both eyes meet criteria, then the eye with the smaller ga lesion will be studied * if the ga lesions are equal in size, then the eye with the best-corrected visual acuity (bcva) will chosen as the study eye * if both eyes have the same lesion size and same bcva, the right eye will be chosen * subjects must have the following ga criteria for inclusion: * ga lesions with an area \> 2.5mm2 and ≤ 20mm2 as determine by fluorescein angiography and fundus autofluorescence * a clear view to the fundus must be present in order to easily examine the study eye at baseline * bcva in the study eye between 20/20 and 20/100 as measured on snellen chart or 85-50 letters by etdrs * willing and able to provide signed informed consent prior to any study participation exclusion criteria: * ga due to a disease other than amd * pregnancy or lactation * treatment of any systemic infection * autofluorescence pattern marked at none, focal or patchy * ocular surgery in the study eye in the previous 6 months. * presence or history of choroidal neovascularization (wet amd) in the study eye * any inflammatory (autoimmune, uveitis) or neovascular (diabetic retinopathy) disease of the retina * any history of glaucoma or disc cupping in the study eye * any history of severe dry eye disease * high myopia \> - 8d or high hyperopia \> +8d in the study eye * presence of life-threatening disease * abnormal basal metabolic panel or liver function tests * current alcohol or other substance abuse * unwilling or unable to provide signed informed consent for any study procedures
treating apoplectic sequela with acupuncture: a randomized controlled study

Conditions: Cerebral Infarction

Summary: the purpose of this study is to evaluate the therapeutic effect of acupuncture method of "xing nao kai qiao" for paralysis as an apoplectic sequela in a multicenter randomized and controlled clinical trial and to compare the efficacy between acupuncture and rehabilitation therapy. in addition, evaluating the trial in the view of medical economics.

this study is a multi-center randomized controlled trial comparing three treatment groups.the trial is completed in the following three hospitals: first teaching hospital of tianjin university of traditional chinese medicine (tcm) of china, tianjin hospital of tcm of china, and qingdao haici medical group of shangdong province of china. the total observation period within this study is 24 weeks for each patient. all patients should remain hemiplegia within 15～90 days after stroke. after randomization the patients will receive 4 sessions of 30 minutes' duration during a period of 4 weeks. the outcome measurement is completed both in the different times as follows: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. 288 patients were randomised into three groups: acupuncture group, rehabilitation group,and acupuncture plus rehabilitation group.the patients in the three groups are blinded as to which treatment method they received. the central randomization is used in this trial, which is performed by the drug clinical research center of shanghai university of tcm of china. this trial is performed according to the principles of the declaration of helsinki (version edinburgh 2000). and the trial protocol has been approved by local institutional review board and ethics committee.

Eligibility criteria:
inclusion criteria: 1. cerebral infarction diagnosed according to the diagnostic standard of western medicine 2. apoplexy diagnosed according to the diagnostic standard of traditional chinese medicine for apoplexy 3. cerebral vascular accident occured in the internal carotid artery system which was verified by cerebral ct or mri 4. the incidence of apoplexy less than twice and the time of onset 15\~3 months 5. age: 40-75 years, non-limited gender 6. nds score of limb functional defect ≥10 7. the patient was alert and the vital signs are stable 8. participant signed the informed consent form exclusion criteria: 1. tia or rind 2. the nerve function defect induced by the cerebral tumor, trauma, parasitic diseases, heart disease and metabolic disorder or hemorrhagic cerebrovascular disease 3. pregnant or breast-feeding women 4. complicated with severe primary disease in heart, liver, kidney and hematology system or psychopath

Keywords: cerebral infarction paralysis acupuncture rehabilitation trial
effectiveness of nerve glide exercises on cubital tunnel syndrome

Conditions: Cubital Tunnel Syndrome

Summary: the objective of this study is to determine if nerve glide exercises in patients with cubital tunnel syndrome can improve pain, paraesthesias and reduce the need for future surgery. cubital tunnel syndrome is a common form of peripheral neuropathy caused by compression of the ulnar nerve at the elbow. surgical intervention is typically reserved for those with severe symptoms, but many cases can be treated with non-operative measures. this study will look at the efficacy of nerve glide exercises in the management of cubital tunnel syndrome. 70 subjects with cubital tunnel syndrome will be enrolled and randomized into groups receiving either standard conservative measures or standard measures in addition to nerve glide exercises. outcomes will be measured 6 months after initiation of treatment with questionnaires on clinical symptoms and function to see if there is a difference between the two groups.


Eligibility criteria:
inclusion criteria: * patients diagnosed with cubital tunnel syndrome on physical exam exclusion criteria: * patients with diagnosed or self-reported cognitive dysfunction * patients who are unable to understand or follow commands * any patient that the investigators feel unsafe or cannot comply with all study related procedures * patients who had previous ulnar nerve release at the elbow * patients with documented cervical spine pathology * patients with clinical signs of other nerve pathology * patients with palpable subluxation of the ulnar nerve at the elbow
injection of tenoxicam versus arthrocentesis alone in the treatment of temporomandibular joint osteoarthritis

Conditions: Arthrocentesis

Summary: the aim of the study is to examine the effectiveness of arthrocentesis plus tenoxicam injection and to compare it with arthrocentesis alone in patients with tmj-oa. thirty patients with tmj-oa who were treated randomly with either arthrocentesis plus tenoxicam injection (tx group) or arthrocentesis alone (control group) were examined. maximum mouth opening (mmo), visual analog scale (vas) pain values, and joint sounds were the outcome variables, which were evaluated at pre-treatment and at 1, 4, 12, and 24 weeks after treatment.

temporomandibular joint osteoarthritis (tmj-oa) is a very painful disease that disrupts the patient's comfort of life. arthrocentesis alone or in combination with intraarticular injections is highly effective in the treatment of tmj-oa. it reduces pain, increases mouth opening, and improves jaw movements. in intra-articular injections, hyaluronic acid, platelet-rich plasma, corticosteroids, and non-steroidal anti-inflammatory drugs (nsaids) are used. tenoxicam is an nsaid that is used systemically or locally in joint diseases such as acute or chronic inflammatory rheumatoid arthritis and osteoarthritis. it has been reported that its long-lasting analgesic effect and anti-inflammatory effect are higher in intra-articular administration than in oral and intravenous administrations , to our knowledge, there has been no such study analysing the effectiveness of intra-articular application of tenoxicam in patients with tmj-oa. the aim of the study is to examine the effectiveness of arthrocentesis plus tenoxicam injection and to compare it with arthrocentesis alone in patients with tmj-oa. thirty patients with tmj-oa who were treated randomly with either arthrocentesis plus tenoxicam injection (tx group) or arthrocentesis alone (control group) were examined. maximum mouth opening (mmo), visual analog scale (vas) pain values, and joint sounds were the outcome variables, which were evaluated at pre-treatment and at 1, 4, 12, and 24 weeks after treatment.

Eligibility criteria:
inclusion criteria: * clinical and radiological diagnosis of tmj-oa * 18 years of age and older * sufficient clinical data at baseline and follow-up. exclusion criteria: * uncontrolled systemic disease * neurological disease * previous tmj surgery * malignant disease in the head and neck region