Kornimate/medical-research-clean huggingface dataset:
comparison of local made and imported porous polyethylene orbital implant for enucleation in thailand

Conditions: Phthisis Bulbi

Summary: this study wants to compare between two types of implants in enucleation. both of them are made from porous polyethylene but have different fabricating techniques. the investigators chose an exposure rate as a main outcome because the investigators think it is the most important outcome for the surgeons. the study hypothesis is: is the exposure rate of a local-made polyethylene orbital implant the same as an imported one?

sample size assessment * the sample size was calculated by using an equivalence formula. from a literature and our own experiences, the success rate for medpor and 3dp were 92% and 94% respectively, the difference (d) of the success rate between two groups was 10% and assuming a 15% of drop out rate. * then allocation sequence was generated by a computerized program, using block of six with varying block size. data management * all definition of data, recruiting techniques, data collection techniques and data management flow were mentioned in the sop. * after double entry technique, each case record form from each site will be sent via datafax system to the data center at center of excellence for biomedical and public health informatics (biophics), thailand. * then data will be validated, analyzed and reported by staff at biophics. plan for missing data * by adding a drop out rate to the sample size calculation. * by choosing the right patients. actually, thai patients have good co-operation especially in surgical research. statistical analysis - intention to treat and per protocol model would be used to see the difference between two types of implants in this project.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of phthisis bulbi, painful blindness, intraocular tumor without metastasis and severe ruptured eyeball * must speak and understand thai language well * must have good consciousness exclusion criteria: * has a history of prior enucleation or evisceration * cannot follow up for at least one year * has recent eye infection within 6 months

Keywords: orbital implant evisceration economic polyethylene porous
adaptive vs. continuous subthalamic nucleus deep brain stimulation in parkinson's disease

Conditions: Deep Brain Stimulation; Parkinson Disease

Summary: the objective of the close-pd study is to compare the efficacy of adaptive deep brain stimulation (adbs) with continue deep brain stimulation (cdbs) in patients with parkinson's disease. the main question it aims to answer is: - whether the change in daily mean on time without troublesome dyskinesia in adbs is greater than cdbs over a six-month follow-up period? researchers will compare adbs to regular continue deep brain stimulation (cdbs). participants will: * be randomized 1:1 to adbs or cdbs; * follow-up will be six months; * complete pd home diary at baseline, two months, four months and at six months.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pd based on the uk brain bank criteria (hughes et al. 1992); * age older than 18 years; * previous implantation of medtronic percepttm pc/rc dbs electrodes bilateral targeting the stn; * reliable beta peak in at least one stn; * able to provide informed consent and comply with the study protocol; * understand the dutch language. exclusion criteria: * legally incompetent adults; * patients with ongoing participation in other clinical trials involving neurological interventions; * inability to recognize the difference between the motor on or off state; * mild cognitive impairment or dementia; * pregnancy.

Keywords: adaptive dbs continue dbs adbs cdbs
effect of enteral immunonutrition on immune, inflammatory markers and nutritional status in patients undergoing gastrectomy for gastric cancer

Conditions: Gastric Cancer; Enteral Immunonutrition

Summary: enteral immunonutrition (ein) has been gaining increasing attention, but data of its immune and anti-inflammatory function in patients undergoing gastrectomy for gastric cancer are poorly investigated. the aim of this study was to assess the effect of ein on immune function, inflammation response and nutrition status when compared to standard enteral nutrition (sen). the investigators believe that the proportion of cluster of differentiation 4 t-cells(cd4＋t-cells), cluster of differentiation 3 t-cells(cd3＋t-cells) and the counts of cd4＋ / cluster of differentiation 8 t-cells (cd8＋), immunoglobulin g(igg), immunoglobulin m(igm), and immunoglobulin a (iga) were larger in ein group, while the level of wbc, crp and tnf-α were lower and nutritional status was similar.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 80 years * with histologically diagnosed cancer of stomach * candidates for elective subtotal or total gastrectomy exclusion criteria: * pregnant or lactating woman, * diagnoses of mental diseases * resent severe concomitant diseases (chronic cardiopulmonary disease, chronic renal failure, etc.) * known allergies to nutrition formula or component * drug intolerance * known immunodeficiency or autoimmune diseases

Keywords: gastric cancer enteral nutrition enteral immunonutrition immune function inflammation response
circadian rhythm in tobramycin elimination in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis is the most common inherited life limiting condition which affects children. patients with it develop lung infections which become difficult to clear, and damage the lungs. these are treated with antibiotics (such as tobramycin) into the vein (termed "intravenous antibiotics"). this has without doubt improved survival. however, all treatments have side effects. tobramycin can cause kidney damage. the investigators have preliminary data that suggests that administering tobramycin in the morning may be safer for the kidneys than administering it in the evening. the investigators plan to approach children and adults with cystic fibrosis whose doctors have decided to administer a course of intravenous tobramycin. the investigators will randomly allocate them to receive it at either 0800h or 2200h. the investigators will measure the rate at which the body eliminates tobramycin from the bloodstream, by measuring the amount of tobramycin in the blood stream after administering the antibiotic. for each patient the study will last for the duration of the course of antibiotics. this is decided by the doctor looking after the patient (rather than the researcher), and would typically be 14 days. the investigators will also measure substances in the blood and urine ("biomarkers") which are sensitive indicators of low levels of kidney injury. the investigators will monitor lung function and lung bacteria in both the groups to ensure that the patients in both groups improve by the same amount. if the preliminary data are proved correct, this research will allow investigators to improve the safety profile of tobramycin, one of the most widely prescribed drugs in cystic fibrosis.


Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis (cf) (defined as clinical features of cf plus a positive sweat test or the presence of 2 genes known to be associated with cf disease) * males or female 5 years and older * treating doctor has decided to commence a course of tobramycin * patient or parent / legal guardian able to give informed consent exclusion criteria: * previous episode of acute kidney injury * solid organ transplantation * evidence of impaired renal function (raised serum creatinine above the normal range for age) * once daily aminoglycoside unsuitable because of hypersensitivity or previous high trough levels on once daily dosing. * pregnancy

Keywords: cystic fibrosis tobramycin pharmacokinetics toxicity
a clinical trial to evaluate the pharmacokinetics and safety/tolerability of fimasartan and atorvastatin in healthy male volunteers.

Conditions: Hypertension, Hyperlipidemia

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety / tolerability of fimasartan and atorvastatin in healthy male volunteers.

this is a randomized, open-label, single dose, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of fimasartan/atorvastatin and co-administration of fimasartan and atorvastatin.

Eligibility criteria:
inclusion criteria: * a healthy male aged 19-50 years * body weight is over 55kg and bmi 18 \~ 27(kg/m2). * a subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol. * a subject who is eligible according to investigator's assessment exclusion criteria: * history or presence of clinically significant medical or psychiatric condition or disease. * history of gastrointestinal disease and resection * hypersensitivity to ingredient of investigational product(ip) and other medication, food. * genetic problem such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption. * a subject who take a drug that inhibit or induce significantly drug-metabolizing enzyme within 1months. * positive results for serum examination(hiv, b and c viral test, syphilis). * seated bp is less than 100/65 mmhg or greater than 140/90 mmhg at screening. * participation in any other study within 3months. * history of whole blood donation within 2months and apheresis 2 weeks.
antisepsis regimen in the surgical treatment of human papilloma virus generated cervical lesions: polyhexamethylene biguanide versus chlorhexidine

Conditions: Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions

Summary: treatments for the macroscopic or pathologic lesions caused by hpv infection can be classified as topical, surgical, destructive, or immunomodulatory. post surgical treatments generally consist of analgesic, anti-inflammatory and topical antimicrobial agents to reduce the risk of local infections. the aim of this study is to compare the efficacy and safety of polyhexamethylene biguanide-based vaginal suppositories to a similar chlorhexidine-based treatment, in the post recovery regimen after surgical treatment of cervical lesions. women who underwent to co2 laser therapy for cervical lesions are randomly assigned to receive 10 days of antiseptic treatment with chlorhexidine digluconate vaginal suppositories, or polyhexamethylene biguanide vaginal suppositories (monogin® / biguanelletm vaginal suppositories, lo.li.pharma, italy). a weekly follow-up check was performed for 6 weeks.


Eligibility criteria:
inclusion criteria: * positive colposcopy examination * positive papanicolaou smear * pathological biopsy * physical ablation by co2 laser therapy for a number of lesions included between 3 and 5 exclusion criteria: * pregnancy

Keywords: laser therapy cervical lesions polyhexamethylene biguanide chlorhexidine
rupp pi pdd: drug and behavioral therapy for children with pervasive developmental disorders

Conditions: Child Development Disorders, Pervasive

Summary: this 24-week study will compare the safety and effectiveness of medication treatment alone (risperidone or aripiprazole) to medication treatment in combination with a parent management training program.

pdd can be a profoundly disabling condition across social, emotional, and academic domains. safe and effective treatments for pdd are needed. participants are randomly assigned to receive either risperidone plus parent management training or risperidone alone for 24 weeks. participants who show deterioration at week 4 will be offered an alternative mediation treatment, aripiprazole. these participants will remain in their original treatment group (either med alone or med plus parent management training). after 6 months of treatment (week 24), participants who respond to their treatment will be gradually discontinued from their medication treatment to learn if the response can be sustained without continued medication treatment (this phase of the study was ended in nov. 2006) adaptive and behavioral outcomes are assessed during the study.

Eligibility criteria:
inclusion criteria: * autistic disorder, asperger's disorder, or pervasive developmental disorder not otherwise specified * weight \> 30 lbs * iq \>= 35 or mental age of at least 18 months exclusion criteria: * psychotic disorder * history of intolerance or nonresponse to risperidone * pregnancy * history of neuroleptic malignant syndrome

Keywords: autistic disorder asperger syndrome
synapdx autism gene expression analysis study

Conditions: Autism

Summary: this study will prospectively enroll approximately 660 children, at least 18 months and less than 5 years of age, who have been referred to a pediatric developmental evaluation centers. enrolled children will have blood drawn for rna gene expression analysis and undergo a clinical evaluation to determine the presence or absence of a diagnosis of asd. the sequential co-primary objectives of this study are: * to develop an algorithm to classify blood rna gene expression patterns to maximize agreement between the classification and a clinical assessment of presence or absence of autism spectrum disorders (asd). * to prospectively assess the clinical sensitivity and specificity of the blood rna gene expression classification algorithm (the sdx-002 test) in children referred to a developmental evaluation clinic for a possible developmental disorder.


Eligibility criteria:
inclusion criteria: 1. referred to a developmental evaluation centers for evaluation of a possible developmental disorder, other than isolated motor problems. 2. age \>= 18 months and \< 5 years. 3. parent/legal guardian has been informed about the study and has signed an informed consent form. exclusion criteria: 1. prior reliable diagnosis of autism spectrum disorder (i.e. prior evaluation by a multi-disciplinary team has already reliably established autism spectrum disorder diagnosis). 2. unable or unwilling to complete study procedures

Keywords: autism autism spectrum disorders rna gene expression developmental delay
nesa neuromodulation versus transcutaneous posterior tibial stimulation

Conditions: Bladder Dysfunction

Summary: introduction: overactive bladder (oab) is a common condition characterized by urinary urgency, frequency, and, in some cases, urge incontinence. non-invasive neuromodulation has emerged as an effective therapeutic option by modulating the neural pathways involved in bladder control. this approach offers a promising alternative for patients who do not respond to conventional treatments. objectives: to evaluate the effect of non-invasive nesa neuromodulation compared to posterior tibial stimulation in patients with overactive bladder. compared to posterior tibial stimulation, with same-day exercises and patient education on quality of life, symptoms, discomfort and sleep. day of the session and patient education on quality of life, symptoms, discomfort and sleep. methods: twenty-four patients (24 women), aged 38-85 years with overactive bladder will be included in this experimental clinical trial study. each patient will attend ten sessions two days a week. patient life quality will be measured using sf-36, sleep quality with the pittsburgh questionnaire, perception of urinari incontinence (ui) symptoms and patient quality of life with the iciq-sf questionnaire. all these variables will be measured before, immediately after the ten sessions and at two months after the end of treatment. ethic: the study was approved by the ethics committee of the university of valencia, and all participants will be given an informed consent form.


Eligibility criteria:
inclusion criteria: * minimum criteria for a primary diagnosis of overactive bladder who have or have not received active/alternative treatments for this pathology. * patients with previous pharmacological treatments that have not obtained an adequate clinical response. * patients whose cognitive abilities are competent to participate in the study and are able to complete the study questionnaires and have given written consent to participate in the study. * without further contraindications for electrotherapy treatment such as serious use of pacemakers, pregnancy, internal bleeding, poor skin condition (ulcerations, wounds...) and/or phobia of electricity. exclusion criteria: * presence of urinary fistula. * infections in the last 12 months. * haematuria during the trial period. * pregnancy or plans to become pregnant during the study. * pathology of the central or peripheral nervous system (multiple sclerosis, parkinson's disease, etc.). * uncontrolled diabetes. * currently treated with botox injections for the bladder or within the last year. * current treatment with interstim or currently implanted interstim device. * bladder outlet obstruction. * urinary retention. * treatment with more than two antidepressants and/or multiple benzodiazepines, as well as antiepileptics. * contraindications for electrotherapy treatment.

Keywords: overactive bladder transcutaneous neuromodulation nesa non-invasive neuromodulation posterior tibial nerve stimulation
the influence of needle-insertion depth on successful epidurogram and clinical outcome in caudal epidural injections

Conditions: Lumbosacral Radicular Pain

Summary: caudal epidural injections have been commonly performed in patients with low back pain and radiculopathy. conventional caudal epidural injections, which the needle is advanced into the sacral canal, present a potential risk of penetration of the epidural venous plexus or dura. the investigators hypothesized that a new caudal injection technique, which the needle only penetrates the sacrococcygeal ligament without being inserted into the sacral canal, might represent a safe alternative, with a lower incidence of intravascular injections and patient's discomfort during the procedure than the conventional technique. the study is designed to investigate the influence of the depth of the inserted needle on successful epidurogram and clinical outcome in caudal epidural injections under the ultrasound and digital subtraction angiography.


Eligibility criteria:
inclusion criteria: * adult patients (20-80 years of age) who were scheduled to receive caudal epidural injection for lumbosacral radicular pain at our pain management clinic exclusion criteria: * pregnancy * coagulopathy * systemic infection * any active infection at the injection site * history of allergy to contrast media, local anesthetics, corticosteroid * patients unable to communicate or patients with cognitive dysfunction
integrase inhibitor (mk-0518) viral decay

Conditions: HIV Infections

Summary: the eradication of hiv by antiretroviral therapy has thus far been elusive. it has been consistently demonstrated that a pool of latently infected, resting cd4+ t cells persists in the majority of hiv-infected individuals receiving antiretroviral therapy in whom plasma viremia has been successfully suppressed for prolonged periods of time; this pool has emerged as the major obstacle in achieving the eradication of hiv. we believe that mk-0518 can further the decay and suppression of hiv-1 in patients who have been virologically suppressed for a prolonged period of time on effective cart (≥ 4 years).

the trial is a prospective, double-blind, randomized, placebo-controlled study with two phases: phase i to 48 weeks and phase ii to 96 weeks with the primary analysis at 48 weeks. hiv-infected individuals who are taking their first standard cart regimen for at least four years with complete viral suppression. upon enrollment, he/she will be randomized to one of two arms: the mk-0518 arm or the control arm. as each participant reaches week 48, he/she will be unblinded and those in the mk-0518 arm will continue taking mk-0518. based on the results of an interim analysis, the control arm will be rolled over to receive mk-0518 for 48 weeks. after the screening, baseline visits and week 4 safety visit, follow-up visits will occur every 8 weeks for both arms.

Eligibility criteria:
inclusion criteria: 1. participant must be hiv-1 infected 2. participant must be 18 years old 3. participant must be taking first standard cart with 2-3 nrtis and 1-2 pis or an nnrti for at least four years (first cart regimen may include changes due to toxicity but not due to virologic failure). 4. participant must have a vl \< 50 copies/ml (using the standard available methods of detection) during the entire time on standard cart except for initial fall of vl and a maximum of two non-consecutive blips of \< 100 copies/ml that the study investigator deems to be not clinically significant 5. female participant must agree to use two methods of birth control or abstinence during the period of the study 6. participant has to have signed full informed consent exclusion criteria: 1. participant who would have difficulty participating in a trial due to non-adherence or substance abuse 2. participant who has taken mono or dual antiretroviral therapy in the past 3. participant who has had a vl \> 50 copies/ml on any antiretroviral regimen 4. participant with any of the following abnormal laboratory test results in screening: * hemoglobin \< 100 g/l * neutrophil count \< 750 cells/l * platelet count \< 50,000 cells/l * ast or alt \> 5x the upper limit of normal * creatinine \> 250 mol/l 5. participant with a malignancy 6. participant with other significant underlying disease (non-hiv) that might impinge upon disease progression or death 7. participant with an active aids-defining illness in the past six months 8. participant who is pregnant

Keywords: chronic hiv infection human immunodeficiency virus treatment experienced
atezolizumab plus bevacizumab versus sintilimab plus bevacizumab with tace and haic in unresectable hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: systemic therapy is the primary option for managing advanced hepatocellular carcinoma (hcc). the combination of atezolizumab and bevacizumab (a+b) has emerged as the first-choice treatment for advanced hcc(im brave 150). the orient-32 study, also reported an orr of 24% for sintilimab plus a bevacizumab biosimilar (s+b) versus 8% for sorafenib, with significantly longer os and pfs. based on those therapeutic advantages over sorafenib, both the a+b and s+b regimens were approved as first-line treatment options for advanced hcc in china. these two trials had very similar designs but included different target populations. our previous studies have demonstrated that a novel treatment approach combining transarterial chemoembolization (tace) with hepatic arterial infusion chemotherapy (haic) has high efficacy in patients with potentially resectable hcc or portal vein tumor thrombus. however, it remains unknown whether combining immune checkpoint inhibitors and macromolecular vegf-targeted therapy with transvascular local interventions could improve patient prognosis in uhcc.


Eligibility criteria:
inclusion criteria: * (a) a confirmed diagnosis of uhcc; * (b) at least one target lesion evaluable by both recist 1.1 and mrecist criteria; * (c) child-pugh grade a or b. exclusion criteria: * (a) previous exposure to other anti-cancer treatments; * (b) diagnosis of any other primary malignancy; * (c) significant esophageal varices or observable red wale marks; * (d) a history of severe cardiac, pulmonary, or renal comorbidities; * (e) incomplete follow-up records.